Active Ingredient (In Each Film-Coated Tablet)
Fexofenadine HCl USP 180 mg
Allergy Relief Tablet, Coated
FDA Label NDC 81522-613
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Fsa Store Inc. (caring Mills) for the product Allergy Relief (NDC 81522-613). 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 film-coated 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 (1-800-222-1222) right away.
Directions
| adults and children 12 years of age and over | take one 18 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
- store between 20-25°C (68-77°F)
- protect from excessive moisture
Inactive Ingredients
colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, pregelatinized starch (maize), polyethylene glycol, titanium dioxide
Questions Or Comments?
call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
*Compare to the active ingredient in Allegra® Allergy 24 Hour
Allergy Relief
Fexofenadine HCl Tablets 180 mg
Antihistamine
24-Hour relief of
- Runny nose
- Sneezing
- Itchy, watery eyes
- Itchy nose or throat
For Indoor & outdoor allergies
Non-drowsy
Caplets**
(**Capsule-shaped tablets)
*This product is not manufactured or distributed by Chattem Inc., distributor of Allegra® Allergy 24 Hour
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
Manufactured for FSA Stores Inc.
240 W. 37th St. 6th Floor
New York, NY 10018
Product Label
CARING MILL FSA STORES Allergy Relief
* Please review the disclaimer below.
