Active Ingredient (In Each Tablet)
Fexofenadine HCl USP, 60 mg
Fexofenadine Hcl Tablet
FDA Label NDC 11822-7652
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rite Aid for the product Fexofenadine Hcl (NDC 11822-7652). 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, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, 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 upper respiratory allergies:
■ runny nose ■ itchy, watery eyes ■ sneezing ■ itching of the nose or throat
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.
Directions
adults and children take one 60 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours
12 years of age and over
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
■ safety sealed: do not use if carton is opened or if individual blister units are torn or opened ■ store between
20° and 25°C (68° and 77°F) ■ protect from excessive moisture
Inactive Ingredients
colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow,
lactose monohydrate, macrogol, magnesium stearate, microcrystalline cellulose, pregelatinized starch, titanium dioxide
Questions Or Comments?
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