Crcle Fexofenadine Hydrochloride
Crcle Fexofenadine Hydrochloride is an FDA drug label for the active ingredient FEXOFENADINE HYDROCHLORIDE manufactured by Innovus Pharmaceuticals, Inc. administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20230408.
Generic: FEXOFENADINE HYDROCHLORIDE
Manufacturer: Innovus Pharmaceuticals, Inc.
Product Type: HUMAN OTC DRUG
Route: ORAL
Dosage Form:
NDC: 57483-230
Application: ANDA211075
Effective: 20230408
Active Ingredients: Active ingredient Fexofenadine HCl USP 60 mg (for 60 mg) Fexofenadine HCl USP 180 mg (for 180 mg)
Indications & Usage
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
Dosage & Administration
Directions adults and children 12 years of age and over take one 60 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours (for 60 mg) take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours (for 180 mg) children under 12 years of age do not use adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor
Contraindications
Not available.
Warnings
Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed do not take at the same time as aluminum or magnesium antacids do not take with fruit juices (see Directions) Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding ask a health professional before use. Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away
Adverse Reactions
Not available.
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