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Cetirizine
Cetirizine Hydrochloride
Cardinal Health 107, Llc
Varies globally
Data not provided.
Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itching of the nose or throat
Directions adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a docto...
Data not provided.
Data not provided.
Global (FDA)
Quflora Pediatric
Vitamin A Acetate, Ascorbic Acid, Cholecalciferol, .Alpha.-Tocopherol, Dl-, Thiamine Hydrochloride, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Levomefolic Acid, Folic Acid, Cyanocobalamin, Magnesium Oxide, Cupric Sulfate, And Sodium Fluoride
Carwin Pharmaceutical Associates, Llc
Varies globally
Data not provided.
INDICATIONS AND USAGE Quflora™ Pediatric Chewable Tablets with 0.5 mg Fluoride is a prescription dietary fluoride supplement providing twelve essential vitamins and minerals.
DOSAGE AND ADMINISTRATION One tablet daily or as prescribed by your healthcare practitioner. Each tablet contains 0.5 mg fluoride ion (F) from 1.1 mg sodium fluoride (NaF).
ADVERSE REACTIONS Allergic rash and other idiosyncrasies have been rarely reported. Call your doctor for medical advice about side effects. You may report side effects or obtain product information by calling Carwin Pharmaceutical Associates, LLC at 1-844-700-5011.
Data not provided.
Global (FDA)
Endocet
Oxycodone And Acetaminophen
Par Health Usa, Llc
Varies globally
Data not provided.
INDICATIONS AND USAGE ENDOCET is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use : Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see WARNINGS ] , rese...
DOSAGE AND ADMINISTRATION Important Dosage and Administration Instructions ENDOCET should be prescribed only by healthcare professionals who are knowledgeable about the use of opioids and how to mitigate the associated risks. Use the lowest effective dosage for the shortest duration of time consistent with individual p...
ADVERSE REACTIONS The following adverse reactions have been identified during post approval use of ENDOCET. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Serious ad...
Data not provided.
Global (FDA)
Xaciato
Clindamycin Phosphate
Organon Llc
Varies globally
Data not provided.
1 INDICATIONS AND USAGE XACIATO is a lincosamide antibacterial indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older. ( 1.1 ) 1.1 Bacterial Vaginosis XACIATO ® is indicated for the treatment of bacterial vaginosis in females 12 years and older [see Use in Specific Populations (...
2 DOSAGE AND ADMINISTRATION The recommended dosage of XACIATO is one applicatorful (5 g of vaginal gel containing 100 mg of clindamycin) administered once intravaginally as a single dose at any time of the day [see Clinical Studies ( 14 )] . Place the used tube with any remaining gel and used applicator in the containe...
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Clostridioides difficile -Associated Diarrhea (CDAD) [see Warnings and Precautions ( 5.1 )] Use with Polyurethane Condoms [see Warnings and Precautions ( 5.2 )] Vaginal Candida Infections [see Warnings an...
Data not provided.
Global (FDA)
Piperacillin And Tazobactam
Piperacillin Sodium And Tazobactam Sodium
Provepharm Inc.
Varies globally
Data not provided.
1 INDICATIONS AND USAGE Piperacillin and tazobactam for injection is a combination of piperacillin, a penicillin-class antibacterial and tazobactam, a beta-lactamase inhibitor, indicated for treatment of: Intra-abdominal infections in adult and pediatric patients 2 months of age and older ( 1.1 ) Nosocomial pneumonia i...
2 DOSAGE AND ADMINISTRATION Adult Patients With Indications Other Than Nosocomial Pneumonia; The usual daily dosage of piperacillin and tazobactam for injection for adults is 3.375 g every six hours totaling 13.5 g (12.0 g piperacillin/1.5 g tazobactam). ( 2.2 ) Adult Patients With Nosocomial Pneumonia: Initial presump...
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Hypersensitivity Adverse Reactions [see Warnings and Precautions ( 5.1 )] • Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.2 )] • Hemophagocytic Lymphohistiocytosis [see Warnings a...
Data not provided.
Global (FDA)
Triple Antibiotic Ointment, Circle K
Triple Antibiotic Ointment
Lil' Drug Store Products, Inc.
Varies globally
Data not provided.
Use Use First aid to help prevent infection in minor cuts scrapes burns
Directions Directions clean the affected area apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily may be covered with a sterile bandage
Data not provided.
Data not provided.
Global (FDA)
Humalog Kwikpen
Insulin Lispro
Eli Lilly And Company
Varies globally
Data not provided.
1 INDICATIONS AND USAGE HUMALOG is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. HUMALOG is a rapid acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. ( 1 )
2 DOSAGE AND ADMINISTRATION See Full Prescribing Information for important administration instructions. ( 2.1 , 2.2 , 2.3 , 2.4 ) Subcutaneous injection ( 2.2 ): Administer HUMALOG ® U-100 or U-200 by subcutaneous injection into the abdominal wall, thigh, upper arm, or buttocks within 15 minutes before a meal or immedi...
6 ADVERSE REACTIONS The following adverse reactions are discussed elsewhere: Hypoglycemia [see Warnings and Precautions ( 5.3 )] . Hypoglycemia Due to Medication Errors [see Warnings and Precautions ( 5.4 )]. Hypersensitivity Reactions [see Warnings and Precautions ( 5.5 )]. Hypokalemia [see Warnings and Precautions ( ...
Data not provided.
Global (FDA)
Colloidal Oatmeal
Colloidal Oatmeal
Meijer, Inc.
Varies globally
Data not provided.
Uses temporarily protects and helps relieve minor skin irritation and itching due to: eczema rashes
Directions apply as needed
Adverse reaction Questions 1-888-593-0593 DISTRIBUTED BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544 www.meijer.com PLASTIC TUBE how2recycle.info OUR QUALITY GUARANTEE The Meijer Family www.meijer.com/satisfaction
Data not provided.
Global (FDA)
Just Cbd Ultra Relief
Menthol, Camphor
Just Brands Llc
Varies globally
Data not provided.
USE Aid for temporary local relief of minor pain in muscles or joints.
DIRECTIONS: Adults over 21 years: Apply a small amount to the affected area. Massage in circular motion until absorbed. Repeat as needed, but no more than 3 to 4 times per day. Wash hands with soap and water after use.
Data not provided.
Data not provided.
Global (FDA)
Just Cbd - Cbd And Thc Ultra Relief
Menthol, Camphor
Just Brands Llc
Varies globally
Data not provided.
USES: Aid for temporary local relief of minor pain in muscles or joints.
DIRECTIONS: Adults over 21 years: Apply a small amount on the affected area. Massage in circular motion, let set for a few seconds. Repeat as neccesary, but no more than 3 to 4 times daily Wash hands with soap and water after use.
Data not provided.
Data not provided.
Global (FDA)
Ondansetron
Ondansetron
Direct_Rx
Varies globally
Data not provided.
Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with: highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2 initial and repeat courses of moderately emetogenic cancer chemotherapy radiotherapy in patients receiving either total body irradiati...
2.1 Dosage The recommended dosage regimens for adult and pediatric patients are described in Table 1 and Table 2, respectively. Corresponding doses of ondansetron tablets, ondansetron orally disintegrating tablets and ondansetron oral solution may be used interchangeably. Table 1: Adult Recommended Dosage Regimen for P...
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. The following adverse r...
Data not provided.
Global (FDA)
Triamterene And Hydrochlorothiazide
Triamterene And Hydrochlorothiazide
Nucare Pharmaceuticals,Inc.
Varies globally
Data not provided.
INDICATIONS AND USAGE: This fixed combination drug is not indicated for the initial therapy of edema or hypertension except in individuals in whom the development of hypokalemia cannot be risked. Triamterene and hydrochlorothiazide tablets are indicated for the treatment of hypertension or edema in patients who develop...
DOSAGE AND ADMINISTRATION: Note: 37.5 mg/25 mg=37.5 mg triamterene and 25 mg hydrochlorothiazide 75 mg/50 mg=75 mg triamterene and 50 mg hydrochlorothiazide The usual dose of triamterene and hydrochlorothiazide 37.5 mg/25 mg, is one or two tablets daily, given as a single dose, with appropriate monitoring of serum pota...
ADVERSE REACTIONS: Side effects observed in association with the use of triamterene and hydrochlorothiazide tablets, other combination products containing triamterene and hydrochlorothiazide, and products containing triamterene or hydrochlorothiazide include the following: Gastrointestinal: jaundice (intrahepatic chole...
Data not provided.
Global (FDA)
Articaine Hydrochloride And Epinephrine
Articaine Hydrochloride, Epinephrine Bitartrate
Burkhart Dental Supply Co., Inc
Varies globally
Data not provided.
1 INDICATIONS AND USAGE Articaine HCl and Epinephrine is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age or older. Articaine HCl and Epinephrine is a combination of articaine HCl, an amide local anesthetic, and epin...
2 DOSAGE AND ADMINISTRATION • For dental procedures by intraoral submucosal infltration or nerve block ( 2.1 ): - For infltration: 0.5 mL-2.5 mL (20 mg-100 mg articaine HCl) ( 2.1 ) - For nerve block: 0.5 mL-3.4 mL (20 mg-136 mg articaine HCl) ( 2.1 ) - For oral surgery: 1 ml-5.1 mL (40 mg-204 mg articaine HCl) ( 2.1 )...
6 ADVERSE REACTIONS Reactions to articaine are characteristic of those associated with other amide-type local anesthetics. Adverse reactions to this group of drugs may also result from excessive plasma levels (which may be due to overdosage, unintentional intravascular injection, or slow metabolic degradation), injecti...
Data not provided.
Global (FDA)
Acetaminophen And Codeine Phosphate
Acetaminophen And Codeine Phosphate
Eywa Pharma Inc
Varies globally
Data not provided.
INDICATIONS AND USAGE Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which ...
DOSAGE AND ADMINISTRATION Important Dosage and Administration Instructions Acetaminophen and codeine phosphate tablets should be prescribed only by healthcare professionals who are knowledgeable about the use of opioids and how to mitigate the associated risks. Use the lowest effective dosage for the shortest duration ...
ADVERSE REACTIONS The following serious adverse reactions are described, or described in greater detail, in other sections: • Addiction, Abuse, and Misuse (see WARNINGS ) • Life-Threatening Respiratory Depression (see WARNINGS ) • Ultra-Rapid Metabolism of Codeine and Other Risk Factors for Life-Threatening Respiratory...
Data not provided.
Global (FDA)
Febuxostat
Febuxostat
Novadoz Pharmaceuticals Llc
Varies globally
Data not provided.
1 INDICATIONS AND USAGE Febuxostat tablets are xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not a...
2 DOSAGE AND ADMINISTRATION Recommended dosage is 40 mg or 80 mg once daily. The recommended starting dosage is 40 mg once daily. For patients who do not achieve a serum uric acid (sUA) less than 6 mg/dL after 2 weeks, the recommended dosage is 80 mg once daily. ( 2.1 ) Patients with severe renal impairment: Limit the ...
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the prescribing information: Cardiovascular Death [ see Warnings and Precautions (5.1)] Hepatic Effects [ see Warnings and Precautions (5.3)] Serious Skin Reactions [ see Warnings and Precautions (5.4)] Adverse reactions in > 1% of p...
Data not provided.
Global (FDA)
Jardiance
Empagliflozin
Cardinal Health 107, Llc
Varies globally
Data not provided.
1 INDICATIONS AND USAGE JARDIANCE is indicated: • to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure. • to reduce the risk of sustained decline in eGFR, end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney disease at...
2 DOSAGE AND ADMINISTRATION • Assess renal function before initiating and as clinically indicated. Assess volume status and correct volume depletion before initiating. ( 2.1 ) • Recommended dosage is 10 mg orally once daily in the morning, taken with or without food. ( 2.2 ) • For additional glycemic control, dosage ma...
6 ADVERSE REACTIONS The following important adverse reactions are described below and elsewhere in the labeling: • Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis [see Warnings and Precautions (5.1) ] • Volume Depletion [see Warnings and Precautions (5.2) ] • Genitourinary Infecti...
Data not provided.
Global (FDA)
Unda 312
Angelica Archangelica, Drosera, Grindelia, Lamium Album, Pinus Sylvestris, Rubus Fruticosus, Senega Officinalis
Seroyal Usa
Varies globally
Data not provided.
Uses For the relief of symptoms associated with sore throat. Directions Adults and adolescents (12 years and older): Take 5 drops three times daily or as recommended by your healthcare practitioner. Children (under 12 years): Take under the direction of your healthcare practitioner. Uses For the relief of symptoms asso...
Directions Adults and adolescents (12 years and older): Take 5 drops three times daily or as recommended by your healthcare practitioner. Children (under 12 years): Take under the direction of your healthcare practitioner. Directions Adults and adolescents (12 years and older): Take 5 drops three times daily or as reco...
Data not provided.
Data not provided.
Global (FDA)
Phesgo
Pertuzumab, Trastuzumab, And Hyaluronidase-Zzxf
Genentech, Inc.
Varies globally
Data not provided.
1 INDICATIONS AND USAGE PHESGO is a combination of pertuzumab and trastuzumab, HER2/neu receptor antagonists, and hyaluronidase, an endoglycosidase, indicated for: Use in combination with chemotherapy as: neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer ...
2 DOSAGE AND ADMINISTRATION For subcutaneous use in the thigh only. ( 2.2 ) PHESGO has different dosage and administration instructions than intravenous pertuzumab and trastuzumab products. ( 2.2 ) Do not administer intravenously. ( 2.2 ) Perform HER2 testing using FDA-approved tests by laboratories with demonstrated p...
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the label: Cardiomyopathy [see Warnings and Precautions (5.1) ] Embryo-Fetal Toxicity [see Warnings and Precautions (5.2) ] Pulmonary Toxicity [see Warnings and Precautions (5.3) ] Exacerbation of Chemotherapy-Induc...
Data not provided.
Global (FDA)
Cetirizine Hydrochloride
Cetirizine Hydrochloride
Sun Pharmaceutical Industries, Inc.
Varies globally
Data not provided.
Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat
Directions may be taken with or without water chew or crush tablets completely before swallowing For 5 mg: adults and children 6 years and over 1 tablet (5 mg) or 2 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than 2 tablets (10mg) in 24 hours. adults 65 years and over 1 tablet (5 mg...
Data not provided.
Data not provided.
Global (FDA)
Diclofenac Sodium Delayed Release
Diclofenac Sodium
Carlsbad Technology, Inc.
Varies globally
Data not provided.
INDICATIONS AND USAGE Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals ( see WARNINGS; Gastrointestina...
DOSAGE AND ADMINISTRATION Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointest...
ADVERSE REACTIONS SECTION The following adverse reactions are discussed in greater detail in other sections of the labeling: Cardiovascular Thrombotic Events (see WARNINGS ) GI Bleeding, Ulceration and Perforation (see WARNINGS ) Hepatotoxicity (see WARNINGS ) Hypertension (see WARNINGS ) Heart Failure and Edema (see W...
Data not provided.
Global (FDA)
Hydrogen Peroxide
Hydrogen Peroxide
Meijer, Inc.
Varies globally
Data not provided.
Uses first aid to help prevent the rise of infection in minor cuts, scrapes and burns aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth
Directions First aid antiseptic: clean the affected area apply a small amount of product on the affected area 1 to 3 times a day may be covered with a sterile bandage if bandaged, let dry first Oral debriding agent (oral rinse): adults and children 2 years of age and over: mix with an equal amount of water swish around...
Adverse reactions Dist. by Meijer Distribution, Inc, Grand Rapids, MI 49544 www.meijer.com
Data not provided.
Global (FDA)
Piperacillin And Tazobactam And Sodium Chloride
Piperacillin And Tazobactam And Sodium Chloride
B. Braun Medical Inc.
Varies globally
Data not provided.
1 INDICATIONS AND USAGE Piperacillin and Tazobactam for Injection and Sodium Chloride Injection, is a combination of piperacillin, a penicillin-class antibacterial and tazobactam, a beta-lactamase inhibitor, indicated for the treatment of: Intra-abdominal infections in adult and pediatric patients 2 months of age and o...
2 DOSAGE AND ADMINISTRATION If a dose of Piperacillin and Tazobactam for Injection and Sodium Chloride injection is required that is not equal to 2.25 g, 3.375 g, or 4.5 g, this product is not recommended for use and an alternative formulation of piperacillin and tazobactam for injection should be considered ( 2.1 ). A...
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Adverse Reactions [see Warnings and Precautions (5.1) ] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.2) ] Hemophagocytic Lymphohistiocytosis [see Warnings and Preca...
Data not provided.
Global (FDA)
Antiseptic Mouth Rinse
Eucalyptol, Menthol, Methyl Salicylate, Thymol
Meijer, Inc.
Varies globally
Data not provided.
Use helps control plaque that leads to gingivitis
Directions adults and children 12 years of age and older - vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonfuls) between teeth twice a day for 30 seconds then spit out; do not swallow children under 12 years of age - consult a dentist or doctor this rinse is not intended to replace brushing or flossing
Adverse Reactions DISTRIBUTED BY MEIJER DISTRIBUTION, INC. GRAND RAPIDS, MI 49544 www. meijer.com OUR QUALITY GUARANTEE The Meijer Family www.meijer.com/satisfaction Empty & Replace Cap PLASTIC BOTTLE how2recycle.info DSP-TN-21091 DSP-MO-20087
Data not provided.
Global (FDA)
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate
Aurolife Pharma, Llc
Varies globally
Data not provided.
INDICATIONS AND USAGE Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed salts of single entity amphetamine product) are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. Attention Deficit Hyperactivity Disor...
DOSAGE AND ADMINISTRATION Regardless of indication, amphetamines should be administered at the lowest effective dosage and dosage should be individually adjusted according to the therapeutic needs and response of the patient. Late evening doses should be avoided because of the resulting insomnia. Attention Deficit Hype...
ADVERSE REACTIONS Cardiovascular Palpitations, tachycardia, elevation of blood pressure, sudden death, myocardial infarction. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use. Central Nervous System Psychotic episodes at recommended doses, overstimulation, restlessness, irritab...
Data not provided.
Global (FDA)
Sterile Diluent For Treprostinil
Water
Dr.Reddy'S Laboratories Inc.,
Varies globally
Data not provided.
1 INDICATIONS AND USAGE Treprostinil injection is a prostacyclin vasodilator indicated for: Treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idio...
2 DOSAGE AND ADMINISTRATION PAH WHO Group 1 in patients with NYHA Class II-IV symptoms : Initial dose for patients new to prostacyclin infusion therapy: 1.25 ng/kg/min; increase based on clinical response (increments of 1.25 ng/kg/min per week for the first 4 weeks of treatment, later 2.5 ng/kg/min per week). Avoid abr...
6 ADVERSE REACTIONS The following adverse reactions are discussed elsewhere in labeling: Infections associated with intravenous administration [see Warnings and Precautions (5.1) ] . Most common adverse reactions (incidence >3%) reported in clinical studies with treprostinil injection: subcutaneous infusion site pain a...
Data not provided.
Global (FDA)
Invokana
Canagliflozin
Cardinal Health 107, Llc
Varies globally
Data not provided.
1 INDICATIONS AND USAGE INVOKANA (canagliflozin) is indicated: • as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. • to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial i...
2 DOSAGE AND ADMINISTRATION • Assess renal function before initiating and as clinically indicated. Assess volume status and correct volume depletion before initiating ( 2.1 ). • The recommended starting dosage in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus is 100 mg orally once d...
6 ADVERSE REACTIONS The following important adverse reactions are described below and elsewhere in the labeling: • Diabetic Ketoacidosis in Patients with Type 1 Diabetes and Other Ketoacidosis [see Warnings and Precautions (5.1) ] • Lower Limb Amputation [see Warnings and Precautions (5.2) ] • Volume Depletion [see War...
Data not provided.
Global (FDA)
Nifedipine
Nifedipine
Cardinal Health 107, Llc
Varies globally
Data not provided.
INDICATIONS AND USAGE I.Vasospastic Angina Nifedipine extended-release tablets are indicated for the management of vasospastic angina confirmed by any of the following criteria: 1) classical pattern of angina at rest accompanied by ST segment elevation, 2) angina or coronary artery spasm provoked by ergonovine, or 3) a...
DOSAGE AND ADMINISTRATION Dosage must be adjusted according to each patient's needs. Therapy for either hypertension or angina should be initiated with 30 or 60 mg once daily. Nifedipine extended-release tablets should be swallowed whole and should not be bitten or divided. In general, titration should proceed over a 7...
ADVERSE EXPERIENCES Over 1000 patients from both controlled and open trials with nifedipine extended-release tablets in hypertension and angina were included in the evaluation of adverse experiences. All side effects reported during nifedipine extended-release tablets therapy were tabulated independent of their causal ...
Data not provided.
Global (FDA)
Potassium Phosphates
Potassium Phosphates
American Regent, Inc.
Varies globally
Data not provided.
1 INDICATIONS AND USAGE Potassium Phosphates Injection is indicated as a source of phosphorus: in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated. for parenteral nutrition in adults and pediatric patients w...
2 DOSAGE AND ADMINISTRATION Administer intravenously only after dilution or admixing in a larger volume of fluid. ( 2.1 ) Potassium Phosphates Injection provides phosphorus 3 mmol/mL (potassium 4.4 mEq/mL). ( 2.2 , 2.4 ) Monitor serum phosphorus, potassium, calcium, and magnesium concentrations. ( 2.2 , 2.4 ) See full ...
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Aluminum Toxicity [see Warnings and Precautions ( 5.5 )] Hypomagnesemia [see Warnings and Precautions ( 5.6 )] Vein Damage and Thrombosis [see Warnings and Precautions ( 5.7 )] The following adverse react...
Data not provided.
Global (FDA)
Zoledronic Acid
Zoledronic Acid
Mylan Institutional Llc
Varies globally
Data not provided.
1 INDICATIONS AND USAGE Zoledronic acid injection is a bisphosphonate indicated for the treatment of: • Hypercalcemia of malignancy ( 1.1 ) • Patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have pr...
2 DOSAGE AND ADMINISTRATION Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Hypercalcemia of malignancy ( 2.1 ) • 4 mg as a single-dose intravenous infusion over no less than 15 minutes. • 4 mg as retreatment...
6 ADVERSE REACTIONS The most common adverse events (greater than 25%) were nausea, fatigue, anemia, bone pain, constipation, fever, vomiting, and dyspnea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial...
Data not provided.
Global (FDA)
Foundcealer Multi-Tasking Foundation Broad Spectrum Spf 20 Sunscreen 13N Fair Neutral
Titanium Dioxide And Zinc Oxide
Tarte, Inc.
Varies globally
Data not provided.
Uses Helps prevent sunburn. If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.
Directions Shake before use. Apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. Children under 6 months: Ask a doctor. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decre...
Data not provided.
Data not provided.
Global (FDA)
Childrens Cold And Cough
Brompheniramine Maleate, Dextromethorphan Hydrobromide
Kroger Company
Varies globally
Data not provided.
Uses • temporarily relieves: • cough • runny nose • sneezing • itching of the nose or throat • itchy, watery eyes due to hay fever (or other upper respiratory allergies) • temporarily alleviates the intensity of coughing
Directions • do not take more than 6 doses in any 24-hour period • measure only with dosage cup provided • keep dosage cup with product • mL = milliliter age dose adults and children 12 years over 20 mL every 4 hours children 6 to under 12 years 10 mL every 4 hours children under 6 years do not use
Data not provided.
Data not provided.
Global (FDA)
Carbidopa And Levodopa
Carbidopa And Levodopa
Dr. Reddy'S Laboratories Inc
Varies globally
Data not provided.
INDICATIONS AND USAGE Carbidopa and levodopa tablets, USP are indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. Carbidopa allows patients treated for Parkinson's disease to use much lowe...
DOSAGE AND ADMINISTRATION The optimum daily dosage of carbidopa and levodopa tablets must be determined by careful titration in each patient. Carbidopa and levodopa tablets are available in a 1:4 ratio of carbidopa to levodopa (25 mg/100 mg) as well as 1:10 ratio (25 mg/250 mg and 10 mg/100 mg). Tablets of the two rati...
ADVERSE REACTIONS The most common adverse reactions reported with carbidopa and levodopa tablets have included dyskinesias, such as choreiform, dystonic, and other involuntary movements, and nausea. The following other adverse reactions have been reported with carbidopa and levodopa tablets: Body as a Whole: chest pain...
Data not provided.
Global (FDA)
Methazolamide
Methazolamide
Padagis Us Llc
Varies globally
Data not provided.
INDICATIONS AND USAGE: Methazolamide Tablets USP is indicated in the treatment of ocular conditions where lowering intraocular pressure is likely to be of therapeutic benefit, such as chronic open-angle glaucoma, secondary glaucoma, and preoperatively in acute angle-closure glaucoma where lowering the intraocular press...
DOSAGE AND ADMINISTRATION: The effective therapeutic dose administered varies from 50 mg to 100 mg two or three times daily. The drug may be used concomitantly with miotic and osmotic agents.
ADVERSE REACTIONS: Adverse reactions, occurring most often early in therapy, include paresthesias, particularly a “tingling” feeling in the extremities; hearing dysfunction or tinnitus; fatigue; malaise; loss of appetite; taste alteration; gastrointestinal disturbances such as nausea, vomiting, and diarrhea; polyuria; ...
Data not provided.
Global (FDA)
Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide
Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide
Teva Pharmaceuticals Usa, Inc.
Varies globally
Data not provided.
1 INDICATIONS AND USAGE Olmesartan medoxomil, amlodipine, hydrochlorothiazide tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and my...
2 DOSAGE AND ADMINISTRATION Dose once daily. Dosage may be increased in 2-week intervals, as needed. The maximum recommended dose of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets is 40 mg/10 mg/25 mg. Dose selection should be individualized based on previous therapy. Dose once daily. Dosage may be i...
6 ADVERSE REACTIONS Most common adverse reactions (incidence ≥2%) are dizziness, peripheral edema, headache, fatigue, nasopharyngitis, muscle spasms, nausea, upper respiratory tract infection, diarrhea, urinary tract infection, and joint swelling ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceutic...
Data not provided.
Global (FDA)
Allopurinol
Allopurinol
Par Health Usa, Llc
Varies globally
Data not provided.
1 INDICATIONS AND USAGE Allopurinol tablets are indicated for: The management of adults with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy) The management of adult and pediatric patients with leukemia, lymphoma and solid tumor malignanc...
2 DOSAGE AND ADMINISTRATION Gout : Prior to initiating treatment assess serum uric acid level, complete blood count, chemistry panel, liver and kidney function tests. Prophylactic treatment for gout flares is recommended. ( 2.1 , 2.2 ) Patients with normal kidney function: Initial dosage is 100 mg orally daily. Increas...
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Skin Rash and Hypersensitivity [see Warnings and Precautions ( 5.1 )] Nephrotoxicity [see Warnings and Precautions ( 5.3 )] Hepatoxicity [see Warnings and Precautions ( 5.4 )] Myelosuppression [see Warnin...
Data not provided.
Global (FDA)
Losartan Potassium And Hydrochlorothiazide
Losartan Potassium And Hydrochlorothiazide
Proficient Rx Lp
Varies globally
Data not provided.
INDICATIONS AND USAGE Hypertension Losartan potassium and hydrochlorothiazide tablets, USP are indicated for the treatment of hypertension. This fixed dose combination is not indicated for initial therapy of hypertension, except when the hypertension is severe enough that the value of achieving prompt blood pressure co...
DOSAGE AND ADMINISTRATION Hypertension Dosing must be individualized. The usual starting dose of losartan is 50 mg once daily, with 25 mg recommended for patients with intravascular volume depletion (e.g., patients treated with diuretics) (see WARNINGS, Hypotension - Volume-Depleted Patients ) and patients with a histo...
ADVERSE REACTIONS Losartan potassium and hydrochlorothiazide has been evaluated for safety in 858 patients treated for essential hypertension and 3889 patients treated for hypertension and left ventricular hypertrophy. In clinical trials with losartan potassium and hydrochlorothiazide, no adverse experiences peculiar t...
Data not provided.
Global (FDA)
Bisoprolol Fumarate And Hydrochlorothiazide
Bisoprolol Fumarate And Hydrochlorothiazide
Unichem Pharmaceuticals (Usa), Inc.
Varies globally
Data not provided.
INDICATIONS AND USAGE Bisoprolol fumarate and hydrochlorothiazide tablets are indicated in the management of hypertension.
DOSAGE AND ADMINISTRATION Bisoprolol is an effective treatment of hypertension in once-daily doses of 2.5 mg to 40 mg, while hydrochlorothiazide is effective in doses of 12.5 to 50 mg. In clinical trials of bisoprolol/hydrochlorothiazide combination therapy using bisoprolol doses of 2.5 to 20 mg and hydrochlorothiazide...
ADVERSE REACTIONS Bisoprolol fumarate and hydrochlorothiazide Bisoprolol fumarate/HCTZ 6.25 mg is well tolerated in most patients. Most adverse effects (AEs) have been mild and transient. In more than 65,000 patients treated worldwide with bisoprolol fumarate, occurrences of bronchospasm have been rare. Discontinuation...
Data not provided.
Global (FDA)
Truvada
Emtricitabine And Tenofovir Disoproxil Fumarate
Gilead Sciences, Inc
Varies globally
Data not provided.
1 INDICATIONS AND USAGE HIV-1 Treatment ( 1.1 ) TRUVADA is a two-drug combination of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), both HIV-1 nucleoside analog reverse transcriptase inhibitors, and is indicated: in combination with other antiretroviral agents for the treatment of HIV-1 infection in adult...
2 DOSAGE AND ADMINISTRATION Testing: Prior to or when initiating TRUVADA test for hepatitis B virus infection. Prior to initiation and during use of TRUVADA, on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all individuals. In individuals...
6 ADVERSE REACTIONS The following adverse reactions are discussed in other sections of the labeling: Severe Acute Exacerbations of Hepatitis B in Patients with HBV Infection [see Warnings and Precautions (5.1) ] . New Onset or Worsening Renal Impairment [see Warnings and Precautions (5.3) ] . Immune Reconstitution Synd...
Data not provided.
Global (FDA)
Olmesartan Medoxomil / Amlodipine Besylate / Hydrochlorothiazide
Olmesartan Medoxomil / Amlodipine Besylate / Hydrochlorothiazide
Endo Usa, Inc.
Varies globally
Data not provided.
1 INDICATIONS AND USAGE Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and...
2 DOSAGE AND ADMINISTRATION Dose once daily. Dosage may be increased in 2 week intervals, as needed. The maximum recommended dose of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is 40/10/25 mg. Dose selection should be individualized based on previous therapy. Dose once daily. Dosage may be increase...
6 ADVERSE REACTIONS Most common adverse reactions (incidence ≥2%) are dizziness, peripheral edema, headache, fatigue, nasopharyngitis, muscle spasms, nausea, upper respiratory tract infection, diarrhea, urinary tract infection, and joint swelling ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Endo at 1-800-828...
Data not provided.
Global (FDA)
Benazepril Hydrochloride And Hydrochlorothiazide
Benazepril Hydrochloride And Hydrochlorothiazide
Padagis Us Llc
Varies globally
Data not provided.
INDICATIONS AND USAGE Benazepril HCl and Hydrochlorothiazide is indicated for the treatment of hypertension. This fixed combination drug is not indicated for the initial therapy of hypertension (see DOSAGE AND ADMINISTRATION ) .
DOSAGE AND ADMINISTRATION Dose once daily. The dosage may then be increased after 2 to 3 weeks as needed to help achieve blood pressure goals. The maximum recommended dose is 20/25 mg. Switch Therapy: A patient whose blood pressure is not adequately controlled with benazepril alone or with hydrochlorothiazide alone may...
ADVERSE REACTIONS Benazepril HCl and Hydrochlorothiazide has been evaluated for safety in over 2500 patients with hypertension; over 500 of these patients were treated for at least 6 months, and over 200 were treated for more than 1 year. The reported side effects were generally mild and transient, and there was no rel...
Data not provided.
Global (FDA)
Guaifenesin And Pseudoephedrine Hcl
Guaifenesin And Pseudoephedrine Hcl
Ohm Laboratories, Inc.
Varies globally
Data not provided.
Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves nasal congestion due to: common cold hay fever upper respiratory allergies temporarily restores freer breathing through the nose promotes nasal and/or ...
Directions do not crush, chew, or break extended-release tablet take with a full glass of water this product can be administered without regard for timing of meals For 600 mg/60 mg: adults and children 12 years and older: 2 extended-release tablets every 12 hours; not more than 4 extended-release tablets in 24 hours Fo...
Data not provided.
Data not provided.
Global (FDA)
Hydrocodone Bitartrate And Acetaminophen
Hydrocodone Bitartrate And Acetaminophen
Camber Pharmaceuticals, Inc.
Varies globally
Data not provided.
INDICATIONS AND USAGE Hydrocodone bitartrate and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: Because of the risks of addiction, abuse, misuse, overdose, and death which can occur at a...
DOSAGE AND ADMINISTRATION Important Dosage and Administration Instructions Hydrocodone bitartrate and acetaminophen tablets should be prescribed only by healthcare professionals who are knowledgeable about the use of opioids and how to mitigate the associated risks. Use the lowest effective dosage for the shortest dura...
ADVERSE REACTIONS The following adverse reactions have been identified during post approval use of hydrocodone and acetaminophen tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationshi...
Data not provided.
Global (FDA)
Esterified Estrogens And Methyltestosterone
Esterified Estrogens And Methyltestosterone
Ani Pharmaceuticals, Inc.
Varies globally
Data not provided.
INDICATIONS AND USAGE Esterified Estrogens and Methyltestosterone Full and Half-Strength Tablets are indicated in the: • Treatment of moderate to severe vasomotor symptoms associated with the menopause in those patients not improved by estrogens alone. (There is no evidence that estrogens are effective for nervous symp...
DOSAGE AND ADMINISTRATION When estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be initiated to reduce the risk of endometrial cancer. A woman without a uterus does not need progestin. Use of estrogen, alone or in combination with a progestin, should be with the lowest effective ...
ADVERSE REACTIONS See BOXED WARNINGS , WARNINGS and PRECAUTIONS . Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in ...
Data not provided.
Global (FDA)
Head And Shoulders Smooth And Silky 2In1
Pyrithione Zinc
The Procter & Gamble Manufacturing Company
Varies globally
Data not provided.
Uses helps prevent recurrence of flaking and itching associated with dandruff.
Directions for best results use at least twice a week or as directed by a doctor. for maximum dandruff control, use every time you shampoo. shake before use. wet hair, massage onto scalp, rinse, repeat if desired.
Data not provided.
Data not provided.
Global (FDA)
Degree Clinical
Cool Rush Invisible Solid 96H Antiperspirant Deodorant
Conopco Inc. D/B/A/ Unilever
Varies globally
Data not provided.
reduces underarm wetness extra effective
apply to underarms only
Data not provided.
Data not provided.
Global (FDA)
Buprenorphine And Naloxone
Buprenorphine And Naloxone
Dr.Reddys Laboratories Inc
Varies globally
Data not provided.
1 INDICATIONS AND USAGE Buprenorphine and naloxone sublingual film is indicated for treatment of opioid dependence. Buprenorphine and naloxone sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support. Buprenorphine and naloxone sublingual film contains bupren...
2 DOSAGE AND ADMINISTRATION Administer buprenorphine and naloxone sublingual film as a single daily dose. ( 2.1 ) Strongly consider recommending or prescribing an opioid overdose reversal agent (e.g., naloxone, nalmefene) at the time buprenorphine and naloxone sublingual film is initiated or renewed because patients be...
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Addiction, Abuse, and Misuse [see Warnings and Precautions ( 5.1 )] Respiratory and CNS Depression [see Warnings and Precautions ( 5.2 ), ( 5.3 )] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions ( 5.5 ...
Data not provided.
Global (FDA)
Fluconazole
Fluconazole
Golden State Medical Supply, Inc.
Varies globally
Data not provided.
INDICATIONS AND USAGE Fluconazole Tablets are indicated for the treatment of: Vaginal candidiasis (vaginal yeast infections due to Candida ). Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, Fluconazole Tablets were also effective for the treatment of Can...
DOSAGE AND ADMINISTRATION Dosage and Administration in Adults Single Dose Vaginal candidiasis: The recommended dosage of fluconazole for vaginal candidiasis is 150 mg as a single oral dose. Multiple Dose SINCE ORAL ABSORPTION IS RAPID AND ALMOST COMPLETE, THE DAILY DOSE OF FLUCONAZOLE IS THE SAME FOR ORAL (TABLETS AND ...
ADVERSE REACTIONS Fluconazole is generally well tolerated. In some patients, particularly those with serious underlying diseases such as AIDS and cancer, changes in renal and hematological function test results and hepatic abnormalities have been observed during treatment with fluconazole and comparative agents, but th...
Data not provided.
Global (FDA)
Pregabalin
Pregabalin
Remedyrepack Inc.
Varies globally
Data not provided.
1 INDICATIONS AND USAGE Pregabalin capsule is indicated for: Management of neuropathic pain associated with diabetic peripheral neuropathy Management of postherpetic neuralgia Adjunctive therapy for the treatment of partial-onset seizures in patients 1month of age and older Management of fibromyalgia Management of neur...
2 DOSAGE AND ADMINISTRATION For adult indications, begin dosing at 150 mg/day. For partial-onset seizure dosing in pediatric patients 1 month of age and older, refer to section 2.4. (2.2 , 2.3 , 2.4 , 2.5 , 2.6 ) Dosing recommendations: INDICATION Dosing Regimen Maximum Dose DPN Pain (2.2) 3 divided doses per day 300 m...
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Angioedema [see Warnings and Precautions (5.1)] Hypersensitivity [see Warnings and Precautions (5.2)] Suicidal Behavior and Ideation [see Warnings and Precautions (5.3)] Increased Risk of Adverse Reactions with Abrupt o...
Data not provided.
Global (FDA)
Antibacterial Hand Refill
Pmcx
Essendant Co.
Varies globally
Data not provided.
Uses / Usos  Handwash to help decrease bacteria on the skin. / Lavado de manos para disminuir las bacterias en la piel.
Directions / Instrucciones  Apply a small amount of product to wet hands, work into lather for 30 seconds, and rinse thoroughly. / Aplique una pequeña cantidad de producto en las manos mojadas, haga espuma durante 30 segundos y enjuague por completo.  Children under 6 years of age should be supervised when using this...
Data not provided.
Data not provided.
Global (FDA)
Advanced Hand Sanitizer
Ethyl Alcohol
Amazon.Com Services Llc
Varies globally
Data not provided.
Uses to decrease bacteria on the skin that could cause disease recommended for repeated use
Directions wet hands thoroughly with product and allow to dry without wiping for children under 6, use only under adult supervision not recommended for infants
ADVERSE REACTION *Effective at eliminating more than 99.99% of many common harmful germs and bacteria in as little as 15 seconds DISTRIBUTED BY: Amazon.com, Services, Inc Seattle, WA 98109 1-877-485-0385 2018 Amazon.com, Inc. or its afiliated. All rights reserved. Solimo and all related logos are are trademarks of Amaz...
Data not provided.
Global (FDA)
Hydroxyzine Hydrochloride
Hydroxyzine Hydrochloride
Northwind Health Company, Llc
Varies globally
Data not provided.
INDICATIONS AND USAGE For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses and in histamine-medi...
DOSAGE AND ADMINISTRATION For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested: adults, 50 to 100 mg q.i.d.; children under 6 years, 50 mg daily in divided doses; children over 6 years, 50 to 100 mg daily in divided doses...
ADVERSE REACTIONS Side effects reported with the administration of hydroxyzine hydrochloride are usually mild and transitory in nature. Anticholinergic: Dry mouth. Central Nervous System: Drowsiness is usually transitory and may disappear in a few days of continued therapy or upon reduction of dose. Involuntary motor a...
Data not provided.
Global (FDA)
Hydrogen Peroxide First Aid Antiseptic
Hydrogen Peroxide
Medline Industries, Lp
Varies globally
Data not provided.
Uses first aid to help prevent the risk of infection in minor cuts, scrapes and burns aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth
Directions First aid antiseptic: Clean the affected area Apply a small amount of product on the area 1 to 3 times a day May be covered with a sterile bandage If bandaged, let dry first Oral debriding agent: adults, children over 2 years of age: mix with an equal amount of water swish around in the mouth over the affect...
Data not provided.
Data not provided.
Global (FDA)
Siliq
Brodalumab
Bausch Health Us Llc
Varies globally
Data not provided.
1 INDICATIONS AND USAGE SILIQ ® (brodalumab) is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies. SILIQ is a human interleukin-17 receptor A (IL-17RA) ...
2 DOSAGE AND ADMINISTRATION Administer 210 mg of SILIQ by subcutaneous injection at Weeks 0, 1, and 2 followed by 210 mg every 2 weeks. ( 2.2 ) 2.1 Tuberculosis Assessment Prior to Initiation of SILIQ Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with SILIQ [see Warnings and Precaution...
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of labeling: Suicidal Ideation and Behavior [see Warnings and Precautions ( 5.1 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.3 )] Infections [ see Warnings and Precautions ( 5.4 )] Crohn’s Di...
Data not provided.
Global (FDA)
Dry Scalp
Pyrithione Zinc
Winco Foods, Llc
Varies globally
Data not provided.
Use Helps prevent recurrence of flaking and itching associated with dandruff
Directions shake well for maximum dandruff control, use every time you shampoo wet hair, massage onto scalp, rinse, repeat if desired for best results use at least twice a week or as directed by a doctor
Adverse Reactions DISTRIBUTED BY: WINCO FOODS, LLC BOISE, ID 83704 100% SATISFACTION GUARANTEE Comments & Questions? www.wincofoods.com
Data not provided.
Global (FDA)
Dandruff
Pyrithione Zinc
Your Military Exchanges
Varies globally
Data not provided.
Use helps prevent recurrence of flaking and itching associated with dandruff
Directions shake well for maximum dandruff control, use every time you shampoo wet hair, massage onto scalp, rinse, repeat if desired for best results use at least twice a week or as directed by a doctor
Adverse Reactions Section "SATISFACTION GUARANTEED OR YOUR MONEY BACK." Distributed To Your Military Exchanges By: Consumer Product Partners, LLC St. Louis, MO 63114 1-888-593-0593
Data not provided.
Global (FDA)
70%
Isopropyl Alcohol
Your Military Exchanges
Varies globally
Data not provided.
Uses First aid to help prevent the risk of infection in: minor cuts scrapes burns
Directions clean the affected area apply a small amount of this product on the affected area 1 to 3 times daily may be covered with a sterile bandage if bandaged, let dry first
ADVERSE REACTION "SATISFACTION GUARANTEED OR YOUR MONEY BACK." Distributed To Your Military Exchanges By: Consumer Product Partners, LLC St. Louis, MO 63114 1-888-593-0593 Pat. D675,101
Data not provided.
Global (FDA)
Vaporizing
Camphor
Walgreen Co.
Varies globally
Data not provided.
Use temporarily relieves cough associated with a cold
Directions see important warnings under "When using this product" adults & children 2 years and older: use 1 tablespoon of solution for each quart of water or 1 1/2 teaspoons of solution for each pint of water add solution directly to cold water only in a hot steam vaporizer follow manufacturer's directions for using v...
ADVERSE REACTION Walgreens Pharmacist Recommended. Our Pharmacists recommend the Walgreens brand. DISTRIBUTED BY: WALGREEN CO. 200 WILMOT RD., DEERFIELD, IL 60015 100% SATISACTION GUARANTEED walgreens.com 2021 Walgreen Co.
Data not provided.
Global (FDA)
Carbamazepine
Carbamazepine
Remedyrepack Inc.
Varies globally
Data not provided.
INDICATIONS AND USAGE Epilepsy Carbamazepine is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: 1. Partial seizures with complex symptomatology (psycho...
DOSAGE AND ADMINISTRATION (SEE TABLE BELOW) Carbamazepine suspension in combination with liquid chlorpromazine or thioridazine results in precipitate formation, and, in the case of chlorpromazine, there has been a report of patient passing an orange rubbery precipitate in the stool following coadministration of the two...
ADVERSE REACTIONS If adverse reactions are of such severity that the drug must be discontinued, the physician must be aware that abrupt discontinuation of any anticonvulsant drug in a responsive epileptic patient may lead to seizures or even status epilepticus with its life-threatening hazards. The most severe adverse ...
Data not provided.
Global (FDA)
Iodine Tincture
Iodine Tincture
Topco Associates Llc
Varies globally
Data not provided.
Use first aid to help prevent skin infection in minor cuts scrapes burns
Directions clean the affected area apply a small amount on the area 1 to 3 times daily may be covered with a sterile bandage if bandaged, let dry first
ADVERSE REACTION DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007 TOPCO VIJA0622 QUESTIONS? 1-888-423-0139 topcare@topco.com www.topcarebrand.com Visit here for more information: http://topbrnds.com/4901ji
Data not provided.
Global (FDA)
Amiodarone Hydrochloride
Amiodarone Hydrochloride
Aurobindo Pharma Limited
Varies globally
Data not provided.
1 INDICATIONS AND USAGE Amiodarone hydrochloride tablets are indicated for the treatment of documented, life-threatening recurrent ventricular fibrillation and life-threatening recurrent hemodynamically unstable tachycardia in adults who have not responded to adequate doses of other available antiarrhythmics or when al...
2 DOSAGE AND ADMINISTRATION Dosage must be individualized based on severity of arrhythmia and response. Use the lowest effective dose. Obtain baseline chest x-ray, pulmonary function tests, thyroid function tests, and liver aminotransferases. Correct hypokalemia, hypomagnesemia, and hypocalcemia before initiating treat...
6 ADVERSE REACTIONS The following serious adverse reactions are described in more detail in other sections of the prescribing information: Pulmonary Toxicity [see Warnings and Precautions (5.2) ] Hepatic Injury [see Warnings and Precautions (5.3) ] Worsened Arrhythmia [see Warnings and Precautions (5.4) ] Visual Impair...
Data not provided.
Global (FDA)
Calcium Gluconate
Calcium Gluconate
Wg Critical Care, Llc
Varies globally
Data not provided.
1 INDICATIONS AND USAGE Calcium Gluconate Injection is indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia. Limitations of Use The safety of Calcium Gluconate Injection for long term use has not been established. • Calcium Gluconate Injection is a form of calcium indicated for...
2 DOSAGE AND ADMINISTRATION • Pharmacy Bulk Package: Not for direct intravenous infusion (2.1) • Administer intravenously (bolus or continuous infusion) via a secure intravenous line (2.1) • See Full Prescribing Information (FPI) for dilution instructions, administration rates, and appropriate monitoring (2.1) • Indivi...
6 ADVERSE REACTIONS The following serious adverse reactions are also described elsewhere in the labeling: • Arrhythmias with Concomitant Cardiac Glycoside Use [see Warnings and Precautions (5.1)] • End-Organ Damage due to Intravascular Ceftriaxone-Calcium Precipitates [see Warnings and Precautions (5.2)] • Tissue Necro...
Data not provided.
Global (FDA)
Icosapent Ethyl
Icosapent Ethyl
Bryant Ranch Prepack
Varies globally
Data not provided.
1 INDICATIONS AND USAGE Icosapent ethyl is indicated: • as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Limitations of Use The effect of icosapent ethyl on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determ...
2 DOSAGE AND ADMINISTRATION • Assess lipid levels before initiating therapy. Identify other causes of high triglyceride levels and manage as appropriate. ( 2.1 ) • Patients should engage in appropriate nutritional intake and physical activity before receiving icosapent ethyl capsules, which should continue during treat...
6 ADVERSE REACTIONS The following important adverse reactions are described below and elsewhere in the labeling: • Atrial Fibrillation or Atrial Flutter [see Warnings and Precautions ( 5.1 )] • Potential for Allergic Reactions in Patients with Fish Allergy [see Warnings and Precautions ( 5.2 )] • Bleeding [see Warnings...
Data not provided.
Global (FDA)
Nicotine Polacrilex
Nicotine Polacrilex
Walgreens
Varies globally
Data not provided.
Use reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
Directions - 2 mg if you are under 18 years of age, ask a doctor before use before using this product, read the enclosed User's Guide for complete directions and other important information begin using the gum on your quit day if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine gum if yo...
Data not provided.
Data not provided.
Global (FDA)
Fluoxetine
Fluoxetine
Remedyrepack Inc.
Varies globally
Data not provided.
1 INDICATIONS AND USAGE Fluoxetine capsules are indicated for the treatment of: Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1) ] . Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2) ] ...
2 DOSAGE AND ADMINISTRATION Indication Adult Pediatric MDD ( 2.1 ) 20 mg/day in am (initial dose) 10 to 20 mg/day (initial dose) OCD ( 2.2 ) 20 mg/day in am (initial dose) 10 mg/day (initial dose) Bulimia Nervosa ( 2.3 ) 60 mg/day in am Panic Disorder ( 2.4 ) 10 mg/day (initial dose) Depressive Episodes Associated with...
6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults [see Boxed Warning and Warnings and Precautions (5.1) ] Serotonin Syndrome [see Warnings and Precautions (5.2) ] Allergic Reactio...
Data not provided.
Global (FDA)
Bio Com 21
Calc Phos, Ferr Phos
Bm Private Limited
Varies globally
Data not provided.
See the enclosed detail for detail
Dosage: Adults: Four tablets three times a day. Children: half of the same or as advised by a homeopathic physician.
Data not provided.
Data not provided.
Global (FDA)
Famotidine
Famotidine
Remedyrepack Inc.
Varies globally
Data not provided.
1 INDICATIONS & USAGE Famotidine tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: active duodenal ulcer (DU). active gastric ulcer (GU). symptomatic nonerosive gastroesophageal reflux disease (GERD). erosive esophagitis due to GERD, diagnosed by biopsy. Famotidine tablets ar...
2 DOSAGE & ADMINISTRATION Indication Recommended Dosage ( 2.1 ) Adult and Pediatric Patients 40 kg and greater Active DU 40 mg once daily; or 20 mg twice daily Active Gastric Ulcer 40 mg once daily GERD 20 mg twice daily Erosive Esophagitis 20 mg twice daily; or 40 mg twice daily Adults Pathological Hypersecretory Cond...
6 ADVERSE REACTIONS The most common adverse reactions are: headache, dizziness, constipation, and diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ascend Laboratories, LLC at 1-877-272-7901 or F DA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are condu...
Data not provided.
Global (FDA)
Bio Com 25 Acidity
Nat Phos, Nat Sulph, Silicea
Bm Private Limited
Varies globally
Data not provided.
See the enclosed detail for detail
Dosage: Adults: Four tablets three times a day. Children: half of the same or as advised by a homeopathic physician.
Data not provided.
Data not provided.
Global (FDA)
Amoxicillin And Clavulanate Potassium
Amoxicillin And Clavulanate Potassium
Aurobindo Pharma Limited
Varies globally
Data not provided.
1 INDICATIONS AND USAGE Amoxicillin and clavulanate potassium for oral suspension is indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below: Lower Respiratory Tract Infections – caused by beta-lactamase–producing ...
2 DOSAGE AND ADMINISTRATION Adults and Pediatric Patients greater than 40 kg: 500 or 875 mg every 12 hours or 250 or 500 mg every 8 hours, based on amoxicillin component. ( 2.2 , 2.3 ) Pediatric patients aged 12 weeks (3 months) and older: 25 to 45 mg/kg/day every 12 hours or 20 to 40 mg/kg/day every 8 hours, up to the...
6 ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling: Anaphylactic reactions [see Warnings and Precautions (5.1) ] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.2) ] Drug-Induced Enterocolitis Syndrome (DIES) [see Warnings and Precautions (5.3) ] Hepatic...
Data not provided.
Global (FDA)
Laura Geller X Bliss Shine - N - Shield Lip Balm Spf 15 Sunset Sands
Zinc Oxide
Cosmax Usa, Corp
Varies globally
Data not provided.
USES Uses: Helps prevent sunburn
DIRECTIONS Apply liberally 15 minutes before sun exposure. Reapply: After 80 minutes of swimming or sweating Immediately after towel drying After eating or drinking As often as necessary
Data not provided.
Data not provided.
Global (FDA)
Glow This Way
Octisalate, Octocrylene, Zinc Oxide, Avobenzone, Homosalate
Koco Life Llc
Varies globally
Data not provided.
Uses • Helps prevent sunburn • If used as directed with other sun protection measures(see Directions), decreases the risk of skin cancer & early skin aging caused by the sun. Uses • Helps prevent sunburn • If used as directed with othersun protection measures(see Directions), decreases therisk of skin cancer and earlys...
Directions Shake well before use. With eyes closed, spray generously and evenlyover your face while holding spray 8-10 inches away. Apply 15 minutesbefore sun exposure. • Reapply: After 40 minutes of swimming orsweating. • Immediately after towel drying. • At least every 2 hours. Do notspray directly into eyes • Sun Pr...
Data not provided.
Data not provided.
Global (FDA)
Potassium Citrate
Potassium Citrate
Xlcare Pharmaceuticals, Inc.
Varies globally
Data not provided.
1 INDICATIONS AND USAGE Potassium citrate extended-release tablets are a citrate salt of potassium indicated for the management of: Renal tubular acidosis (RTA) with calcium stones (1.1) Hypocitraturic calcium oxalate nephrolithiasis of any etiology (1.2) Uric acid lithiasis with or without calcium stones (1.3) 1.1 Ren...
2 DOSAGE AND ADMINISTRATION Objective: To restore normal urinary citrate (greater than 320 mg/day and as close to the normal mean of 640 mg/day as possible), and to increase urinary pH to a level of 6.0 to 7.0. Severe hypocitraturia (urinary citrate < 150 mg/day): therapy should be initiated at 60 mEq per day; a dose o...
6 ADVERSE REACTIONS Some patients may develop minor gastrointestinal complaints such as abdominal discomfort, vomiting, diarrhea, loose bowel movements or nausea. These may be alleviated by taking the dose with meals or snacks or by reducing the dosage (6.1) To report SUSPECTED ADVERSE REACTIONS, contact XLCare Pharmac...
Data not provided.
Global (FDA)
Dexmethylphenidate Hydrochloride
Dexmethylphenidate Hydrochloride
Granules Pharmaceuticals Inc.
Varies globally
Data not provided.
1 INDICATIONS AND USAGE Dexmethylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14 )]. Limitations of Use The use of dexmethylphenidate hydrochloride extended-release capsules is not recommended in pediatric pat...
2 DOSAGE AND ADMINISTRATION N/A • Patients new to methylphenidate: Recommended starting dose is 5 mg once daily for pediatric patients and 10 mg once daily for adults with or without food in the morning ( 2.2 ). • Patients currently on methylphenidate: Dexmethylphenidate hydrochloride extended-release capsules dosage i...
6 ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling: • Abuse, Misuse, and Addiction [see Boxed Warning , Warnings and Precautions (5.1) , Drug Abuse and Dependence ( 9.2 , 9.3 )] • Known hypersensitivity to methylphenidate or other ingredients of dexmethylphenidate hydrochlo...
Data not provided.
Global (FDA)
Benzalkonium Chloride
Benzalkonium Chloride
Family Dollar Stores, Inc
Varies globally
Data not provided.
Use for handwashing to decrease bacteria on the skin
Directions wet hands apply palmful to hands scrub thoroughly rinse thoroughly
ADVERSE REACTION DISTRIBUTED BY: MIDWOOD BRANDS, LLC 500 VOLVO PKWY, CHESAPEAKE, VA 23320 USA MADE IN USA WITH US & FOREIGN COMPONENTS 100% SATISFACTION OR YOUR MONEY BACK! NOT 100% SATISFIED? Return within 30 days to the store of purchase for a refund (with receipt) or exchange.
Data not provided.
Global (FDA)
Dove Clinical Care
Cool Essentials Soft Solid 96H Protection Antiperspirant Deodorant
Conopco Inc. D/B/A/ Unilever
Varies globally
Data not provided.
Reduces underarm wetness Extra effective
apply to underarms only. Before bed, apply two clicks of product to each underarm
Data not provided.
Data not provided.
Global (FDA)
Esomeprazole Magnesium
Esomeprazole Magnesium
Ncs Healthcare Of Ky, Llc Dba Vangard Labs
Varies globally
Data not provided.
1 INDICATIONS AND USAGE Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the: Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. ( 1.1 ) Maintena...
2 DOSAGE AND ADMINISTRATION 1 A maximum dosage of 20 mg once daily is recommended for patients with severe liver impairment (Child-Pugh Class C). 2 Controlled studies do not extend beyond 6 months. 3 Refer to the amoxicillin and clarithromycin prescribing information for dosage adjustments in elderly and renally-impair...
6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in labeling: Acute Tubulointerstitial Nephritis [see Warnings and Precautions (5.2) ] Clostridium difficile -Associated Diarrhea [see Warnings and Precautions (5.3) ] Bone Fracture [see Warnings and Precautions (5.4) ] Severe ...
Data not provided.
Global (FDA)
Methimazole
Methimazole
Preferred Pharmaceuticals Inc.
Varies globally
Data not provided.
INDICATIONS AND USAGE Methimazole tablets are indicated: • In patients with Graves’ disease with hyperthyroidism or toxic multinodular goiter for whom surgery or radioactive iodine therapy is not an appropriate treatment option. • To ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive...
DOSAGE AND ADMINISTRATION Methimazole tablets are administered orally. The total daily dosage is usually given in 3 divided doses at approximately 8-hour intervals. Adult - The initial daily dosage is 15 mg for mild hyperthyroidism, 30 to 40 mg for moderately severe hyperthyroidism, and 60 mg for severe hyperthyroidism...
ADVERSE REACTIONS Major adverse reactions (which occur with much less frequency than the minor adverse reactions) include inhibition of myelopoiesis (agranulocytosis, granulocytopenia, thrombocytopenia, and aplastic anemia), drug fever, a lupus-like syndrome, insulin autoimmune syndrome (which can result in hypoglycemi...
Data not provided.
Global (FDA)
Nicardipine Hydrochloride
Nicardipine Hydrochloride
Amici Pharma Inc
Varies globally
Data not provided.
INDICATIONS AND USAGE I. Stable Angina Nicardipine hydrochloride capsules are indicated for the management of patients with chronic stable angina (effort-associated angina). Nicardipine hydrochloride capsules may be used alone or in combination with beta-blockers. II. Hypertension Nicardipine hydrochloride capsules are...
DOSAGE AND ADMINISTRATION Angina The dose should be individually titrated for each patient beginning with 20 mg three times daily. Doses in the range of 20 to 40 mg three times a day have been shown to be effective. At least 3 days should be allowed before increasing the nicardipine hydrochloride capsules dose to ensur...
ADVERSE REACTIONS In multiple-dose U.S. and foreign controlled short-term (up to 3 months) studies 1910 patients received nicardipine hydrochloride capsules alone or in combination with other drugs. In these studies adverse events were reported spontaneously; adverse experiences were generally not serious but occasiona...
Data not provided.
Global (FDA)
Clonidine Hydrochloride
Clonidine Hydrochloride
Bryant Ranch Prepack
Varies globally
Data not provided.
INDICATIONS AND USAGE Clonidine hydrochloride tablets USP are indicated in the treatment of hypertension. Clonidine hydrochloride tablets USP may be employed alone or concomitantly with other antihypertensive agents.
DOSAGE AND ADMINISTRATION Adults The dose of clonidine hydrochloride tablets USP must be adjusted according to the patient’s individual blood pressure response. The following is a general guide to its administration. Initial Dose 0.1 mg tablet twice daily (morning and bedtime). Elderly patients may benefit from a lower...
ADVERSE REACTIONS Most adverse effects are mild and tend to diminish with continued therapy. The most frequent (which appear to be dose-related) are dry mouth, occurring in about 40 of 100 patients; drowsiness, about 33 in 100; dizziness, about 16 in 100; constipation and sedation, each about 10 in 100. The following l...
Data not provided.
Global (FDA)
Triderma Eczema Fast Healing Face Body
E Relief
Genuine Virgin Aloe Corporation
Varies globally
Data not provided.
USES temporarily protects and helps relieve minor skin irritation and itching due to: •eczema •rashes
DIRECTIONS apply twice a day or as often as needed.
Data not provided.
Data not provided.
Global (FDA)
Bupivacaine Hydrochloride
Bupivacaine Hydrochloride
Sportpharm Llc
Varies globally
Data not provided.
1 INDICATIONS AND USAGE Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. S...
2 DOSAGE AND ADMINISTRATION Not for intrathecal use. ( 2.1 ) Avoid use of solutions containing antimicrobial preservatives (i.e., multiple-dose vials) for epidural or caudal anesthesia. ( 2.1 , 5.4 ) Three mL of Bupivacaine Hydrochloride and Epinephrine Injection without antimicrobial preservative (0.5% bupivacaine wit...
6 ADVERSE REACTIONS The following clinically significant adverse reactions have been reported and described in the Warnings and Precautions section of the labeling: Cardiac Arrest in Obstetrical Anesthesia [see Warnings and Precautions (5.1) ] Dose-Related Toxicity [see Warnings and Precautions (5.2) ] Methemoglobinemi...
Data not provided.
Global (FDA)
Nighttime Cold And Flu Mini Softgels
Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl
Shield Pharmaceuticals Corp
Varies globally
Data not provided.
Uses temporarily relieves common cold/flu symptoms: • cough due to minor throat & bronchial irritation • sore throat • headache• minor aches & pains• fever• runny nose & sneezing
Directions • take only as directed • do not exceed 8 softgels per 24 hrs • adults & children 12 yrs & over 2 Softgels with water every 6 hrs • children 4 to under 12 yrs ask a doctor • children under 4 yrs do not use
Data not provided.
Data not provided.
Global (FDA)
Hand Sanitizer Vitamin E And Aloe Vera
Ethyl Alcohol
Ningbo Rejoice International
Varies globally
Data not provided.
For handwashing to decrease bacteria on the skin Recommended for repeated use
Wet hands thoroughly with product Briskly rub hands together until dry Supervise children under 6 years in the use of this product
Data not provided.
Data not provided.
Global (FDA)
Triamcinolone Acetonide
Triamcinolone Acetonide
Asclemed Usa Inc.
Varies globally
Data not provided.
INDICATIONS AND USAGE Intramuscular Where oral therapy is not feasible, injectable corticosteroid therapy, including triamcinolone acetonide injectable suspension is indicated for intramuscular use as follows: Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of con...
DOSAGE AND ADMINISTRATION General NOTE: CONTAINS BENZYL ALCOHOL (see PRECAUTIONS ). The initial dose of triamcinolone acetonide injectable suspension may vary from 2.5 mg to 100 mg per day depending on the specific disease entity being treated (see Dosage section below). However, in certain overwhelming, acute, life-th...
ADVERSE REACTIONS (listed alphabetically under each subsection) The following adverse reactions may be associated with corticosteroid therapy: Allergic reactions: Anaphylaxis including death, angioedema. Cardiovascular: Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congest...
Data not provided.
Global (FDA)
Signature Select Instant Hand Sanitizer Wipes With Aloe Vera
Alcohol
Living Better Brands Llc
Varies globally
Data not provided.
Uses For hand washing to decrease bacteria on the skin Recommended for repeated use Dries in seconds
Directions: Tear open packet Open and unfold wipe Thoroughly wipe hands, fingers, and wrists. Be sure to use the entire wipe. For dirty hands, use first wipe to clean hands, then discard wipe, sanitize with second wipe. Discard after single use
Data not provided.
Data not provided.
Global (FDA)
Medicated Apricot Scrub
Salicylic Acid
Retail Business Services, Llc
Varies globally
Data not provided.
Use for the treatment of acne
Directions moisten face with water. Apply product with wet fingertips and massage over face. Rinse well and pat dry. avoid contact with the eyes. If contact occurs, flush thoroughly with water.
ADVERSE REACTION DISTRIBUTED BY: ADUSA DISTRIBUTION, LLC SALISBURY, NC 28147 For product questions or concerns, contact us at 1-833-992-3872. Quality guaranteed or your money back. PLASTIC TUBE how2recycle.info
Data not provided.
Global (FDA)
Ashleybelle Moisturizing Hand Sanitizer Blueberry Freesia
Ethyl Alcohol
My Imports Usa Llc
Varies globally
Data not provided.
Uses Hand sanitizer to help reduce bacteria on the skin that could cause disease Recommended for repeated use.
Directions Wet hands thoroughly with product and allow to dry without wiping. For children under 6, do not use without adult supervision Not recommended for infants.
Data not provided.
Data not provided.
Global (FDA)
Foster And Thrive Sf Honey Lemon Cough Drops
Menthol
Mckesson
Varies globally
Data not provided.
Uses temporarily relieves: cough as may occur with a cold occasional minor irritation and sore throat
Directions adults and children 5 years and over - dissolve 1 lozenge slowly in mouth. Repeat every 2 hours as needed or as directed by a doctor children under 5 years - ask a doctor
Data not provided.
Data not provided.
Global (FDA)
Burn Relief
Lidocaine
Walmart Inc.
Varies globally
Data not provided.
Uses for temporary relief of pain and itching associated with: sunburn minor cuts scrapes minor burns insect bites minor skin irritations
Directions shake can well adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily children under 2 years of age: consult a doctor to apply to face, spray in palm of hand and gently apply
Data not provided.
Data not provided.
Global (FDA)
Daily Moisturizing
Dimethicone
Lidl Us, Llc
Varies globally
Data not provided.
Uses helps prevent and temporarily protects chafed, chapped or cracked skin helps protect from the drying effects of wind and cold weather
Directions apply as needed
ADVERSE REACTION DISTRIBUTED BY LIDL US, LLC 3500 S. Clark Street Arlington, VA 22202 QUESTIONS? 1-844-344-5071 www.lidl.com STORE UPRIGHT IN A COOL, DRY PLACE. LiDL love it! Guarantee money refunded item replaced Empty & Discard Pump PLASTIC BOTTLE how2recycle.info
Data not provided.
Global (FDA)
Guanfacine
Guanfacine
Coupler Llc
Varies globally
Data not provided.
INDICATIONS AND USAGE Guanfacine tablets, USP are indicated in the management of hypertension. Guanfacine tablets, USP may be given alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.
DOSAGE AND ADMINISTRATION The recommended initial dose of guanfacine tablets when given alone or in combination with another antihypertensive drug is 1 mg daily given at bedtime to minimize somnolence. If after 3 weeks to 4 weeks of therapy 1 mg does not give a satisfactory result, a dose of 2 mg may be given, although...
ADVERSE REACTIONS Adverse reactions noted with guanfacine hydrochloride are similar to those of other drugs of the central α 2 -adrenoreceptor agonist class: dry mouth, sedation (somnolence), weakness (asthenia), dizziness, constipation, and impotence. While the reactions are common, most are mild and tend to disappear...
Data not provided.
Global (FDA)
Healmusz Numbing
Healmusz Numbing
Jiangxi Yudexi Pharmaceutical Co., Ltd
Varies globally
Data not provided.
Use ·Temporarily relieves pain and itching due to: minor burns,sunburn, insect bites, scrapes, minor skin irritations
Directions ·Cleanse targeted skin area, pat dry. ·Apply a thin layer to the affected area, not more than 3-4 times daily.
Data not provided.
Data not provided.
Global (FDA)
Metoclopramide Hydrochloride
Metoclopramide Hydrochloride
Chartwell Rx, Llc
Varies globally
Data not provided.
INDICATIONS AND USAGE The use of Metoclopramide Oral Solution is recommended for adults only. Therapy should not exceed 12 weeks in duration. Symptomatic Gastroesophageal Reflux Metoclopramide Oral Solution is indicated as short-term (4 to 12 weeks) therapy for adults with symptomatic, documented gastroesophageal reflu...
DOSAGE AND ADMINISTRATION Therapy with metoclopramide oral solution should not exceed 12 weeks in duration. For the Relief of Symptomatic Gastroesophageal Reflux Administer from 10 mg to 15 mg metoclopramide orally up to q.i.d. 30 minutes before each meal and at bedtime, depending upon symptoms being treated and clinic...
ADVERSE REACTIONS In general, the incidence of adverse reactions correlates with the dose and duration of metoclopramide administration. The following reactions have been reported, although in most instances, data do not permit an estimate of frequency: CNS Effects Restlessness, drowsiness, fatigue, and lassitude occur...
Data not provided.
Global (FDA)
Minidrops
Lubricant Eye Drops
Optics Laboratory, Inc
Varies globally
Data not provided.
INDICATIONS AND USE SECTION USES FOR TEMPORARY RELIEF OF BURNING AND IRRITATION DUE TO DRYNESS OF THE EYE FOR USE AS A PROTECTANT AGAINST FURTHER IRRITATION OR TO RELIEVE DRYNESS OF THE EYE
DOSAGE AND ADMINISTRATION SECTION DIRECTIONS TWIST OFF TAB COMPLETELY TO OPEN. INSTILL 1 TO 2 DROPS IN THE AFFECTED EYE(S) AS NEEDED. DISCARD DROPPER AND DO NOT REUSE.
Data not provided.
Data not provided.
Global (FDA)
Periosciences White Care Ao Pro
Sodium Fluoride
Periosciences Llc
Varies globally
Data not provided.
Uses Aids in prevention of dental cavities.
Directions Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable o...
Data not provided.
Data not provided.
Global (FDA)
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