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Drug Facts
Distributed by:
CVS Pharmacy, Inc.
One CVS Drive
Woonsocket, RI 02895
Fexofenadine Hydrochloride Tablet
FDA Label NDC 51316-800
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 Pharmacy, Inc for the product Fexofenadine Hydrochloride (NDC 51316-800). 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 other, active ingredient (in each tablet), purpose, uses, otc - do not use, otc - ask doctor, when using this product, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Tablet)
Fexofenadine HCl, USP 180 mg
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
Otc - Do Not Use
Do not use if you have ever had an allergic reaction to this product or any of its ingredients
Otc - Ask Doctor
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)
Otc - Stop Use
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
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 (1-800-222-1222).
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 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 inner safety seal is torn or missing
- store between 20° to 25°C (68° to 77°F)
- protect from excessive moisture
Inactive Ingredients
croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized maize starch, titanium dioxide
Questions Or Comments?
Call toll-free weekdays 8:30 AM to 5 PM EST at 1-800-818-4555.
Principal Display Panel - 180 Mg Tablet Bottle Carton
CVS Health®
Compare to the active ingredient in
Allegra® Allergy 24 Hour Tablets*
NDC 51316-800-70
Allergy Relief
FEXOFENADINE HYDROCHLORIDE
TABLETS, USP 180 mg
Antihistamine
INDOOR/OUTDOOR
ALLERGY RELIEF
24
HOUR
- Sneezing
- Runny nose
- Itchy, watery eyes
- Itchy nose or throat
Non-Drowsy
Package Contains
One Bottle
70 TABLETS
Actual Size
Principal Display Panel (180 mg Tablet Bottle Carton)
* Please review the disclaimer below.
