12HR Allergy Relief
12HR Allergy Relief is an FDA drug label for the active ingredient FEXOFENADINE HYDROCHLORIDE manufactured by CARDINAL HEALTH 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 20210924.
Generic: FEXOFENADINE HYDROCHLORIDE
Manufacturer: CARDINAL HEALTH
Product Type: HUMAN OTC DRUG
Route: ORAL
Dosage Form:
NDC: 70000-0586
Application: ANDA211075
Effective: 20210924
Active Ingredients: Active ingredient (in each tablet) Fexofenadine HCl 60 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 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 (1-800-222-1222).
Adverse Reactions
Not available.
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