Active Ingredient (In Each Tablet)
Fexofenadine HCl 60mg
Fexofenadine Tablet
FDA Label NDC 73581-012
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Yyba Corp for the product Fexofenadine (NDC 73581-012). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antihistamine
Uses
temporarily relieves these symptoms due to hay fever or other respiratory allergies:
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
Warnings
Do not use if you ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before using 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 healthcare professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
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
Other Information
- store between 20 and 25 degrees celcius (68-77 farenheit)
- protect from excessive moisture
- FDA approved dissolution specifications differ from the USP.
Inactive Ingredients
Colloidal Silicon Dioxide, Croscarmellose Sodium, Ferric Oxide Red, Ferric Oxide Yellow, Hypromellose, Lactose Monohydrate, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol 400, Povidone, Titanium Dioxide.
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