Active Ingredient (In Each Tablet)
Fexofenadine HCl USP, 180mg
Fexofenadine Hcl Tablet
FDA Label NDC 79481-6230
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Meijer, Inc. for the product Fexofenadine Hcl (NDC 79481-6230). 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 12 years of age and over take one 180 mg tablet
with water once a day;
do not take more than 1
tablet in 24 hours
children under 12 years of age do not use
adults 65 years of age ask a doctor
and older
consumers with kidney ask a doctor
disease
Other Information
safety sealed: do not use if imprinted foil under bottle cap is opened or torn
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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