Active Ingredient (In Each Film-Coated Tablet)
Fexofenadine HCl USP 180 mg
Iallergy Relief Tablet, Coated
FDA Label NDC 21130-405
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Safeway, Inc. for the product Iallergy Relief (NDC 21130-405). 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
- each tablet contains: sodium 8 mg
- store between 20-25°C (68-77°F)
- protect from excessive moisture
- this product meets the requirements of USP Dissolution Test 2
Inactive Ingredients
anhydrous lactose,colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, lactose monohydrate, pregelatinized starch (maize), polyethylene glycol, red iron oxide, stearic acid, titanium dioxide, and yellow iron oxide
Questions Or Comments?
call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
COMPARE TO Allegra® Allergy 24 Hr active ingredient*
24 Hour | Original Prescription Strength
Allergy Relief
FEXOFENADINE HCI 180mg
Antihistamine Coated Caplets
- Relief of Runny nose, sneezing, itchy nose or throat, itchy & watery eyes
- For indoor and outdoor allergies
- Non-drowsy
COATED CAPLETS**
(**Capsule-shaped tablets)
*This product is not manufactured or distributed by Chattem Inc., distributor of Allegra® Allergy 24 HR.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
DISTRIBUTED BY:
BETTER LIVING BRANDS LLC
P.O. BOX, PLEASANT, CA 94566-0009
Product Label
SIGNATURE CARE Allergy Relief
* Please review the disclaimer below.
