Active Ingredient (In Each Film-Coated Tablet)
Fexofenadine HCl USP 180 mg
Allergy Relief Tablet, Coated
FDA Label NDC 41250-506
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 Allergy Relief (NDC 41250-506). 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 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 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, lactose monohydrate, pregelatinized starch (maize), stearic acid, hypromellose, polyethylene glycol, red iron oxide, 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 hour active ingredient***
NON-DROWSY
Allergy Relief
Fexofenadine HCI Caplets | 180 mg | Antihistamine
INDOOR & OUTDOOR ALLERGIES
24 HOUR RELIEF OF:
Sneezing; Runny Nose; Itchy, Watery Eyes; Itchy Throat or Nose
ORIGINAL PRESCRIPTION STRENGTH
COATED 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 CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN, OR SHOWS ANY SIGNS OF TAMPERING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
DIST. BY MEIJER
DISTRIBUTION, INC.
GRAND RAPIDS, MI 49544
Product Label
MEIJER Non-Drowsy Allergy Relief
* Please review the disclaimer below.
