Active Ingredient (In Each Film-Coated Tablet)
Fexofenadine HCL 180 mg
Fexofenadine Hydrochloride Tablet
FDA Label NDC 51655-231
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Northwind Health Company, Llc for the product Fexofenadine Hydrochloride (NDC 51655-231). 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 (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
- each tablet contain: sodium 8 mg
- store between 20 to 25°C (68 to 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, polyethylene glycol, pregelatinized starch (maize), red iron oxide, stearic acid, titanium dioxide, and yellow iron oxide
Questions Or Comments?
Call: 1-800-616-2471
Principal Display Panel
COMPARE TO the active ingredient in ALLEGRA® ALLERGY 24 HOUR*
FEXOFENADINE HYDROCHLORIDE USP 180 mg
Antihistamine
ALLERGY RELIEF
24-HOUR Relief of:
- sneezing
- Runny nose
- Itchy, watery eyes
- Itchy nose or throat
Indoor and Outdoor
Allergy Relief
Non-Drowsy
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
Distributed by:
MAJOR® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152
Product Label
NDC: 51655-231-26
Label (51655 231 26)
* Please review the disclaimer below.
