Active Ingredient (In Each Tablet)
Fexofenadine HCl USP 180 mg
Allergy Relief Tablet
FDA Label NDC 55319-965
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Family Dollar (family Wellness) for the product Allergy Relief (NDC 55319-965). 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 (1-800-222-1222) 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
- 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, polyethylene glycol, magnesium stearate, microcrystalline cellulose, titanium dioxide
Questions Or Comments?
call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
*Compare to active ingredient in Allegra® Allergy 24 HR
Allergy Relief
Fexofenadine HCl Tablets USP, 180 mg
Antihistamine
24 hour relief of
- Runny nose
- Sneezing
- Itchy, watery eyes
- Itchy nose or throat
For indoor and 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 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.
DISTRIBUTED BY
MIDWOOD BRANDS, LLC
500 VOLVO PARKWAY
CHESAPEAKE, VA 23320
Product Label
FAMILY WELLNESS Allergy Relief
* Please review the disclaimer below.
