Active Ingredient (In Each Tablet)
Fexofenadine HCl USP, 180 mg
Fexofenadine Hcl Tablet
FDA Label NDC 51316-768
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs for the product Fexofenadine Hcl (NDC 51316-768). 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, do not use, 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
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 take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours
Other Information
■ safety sealed: do not use if imprinted safety seal under cap is broken or missing
■ store between 20° and 25°C (68° and 77°F)
■ protect from excessive moisture
Inactive Ingredients
ammonium hydroxide, colloidal silicon dioxide, croscarmellose sodium, D & C Red 33, ferrosoferric oxide, FD & C blue 1, FD & C yellow 6, gelatin, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol,
pregelatinized starch, propylene glycol, shellac, titanium dioxide.
Questions Or Comments?
contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST
Pdp
Fexo 180mg Gelcaps (Cder 60ct)
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