Active Ingredient
(in each tablet)
Fexofenadine HCI 180 mg
Allegra Allergy Tablet, Coated
FDA Label NDC 41167-4122
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Chattem, Inc. for the product Allegra Allergy (NDC 41167-4122). 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, purpose, uses, do not use, ask a doctor before use if you have, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children., 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
- sneezing
- itchy, water eyes
- 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
- safety sealed: do not use if carton is opened or if individual blister units are torn or opened
- store between 20° and 25°C (68° and 77°F)
- protect from excessive moisture
Inactive Ingredients
croscarmellose sodium, D&C red 28, D&C red 33, FD&C blue 1, gelatin, hydroxypropylcellulose, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, PEG-135, pharmaceutical ink, pregelatinized starch, titanium dioxide
Questions or comments?
call toll-free 1-800-633-1610 or www.allegra.com
The makers of Allegra® do not make store brand products. The trade dress of this Allegra® package is subject to trademark protection.
Dist. By: Chattem, Inc., a Sanofi Company, Chattanooga, TN 37409-0219 ©2014
Principal Display Panel
NDC 41167-4122-0
Allegra® Allergy
Fexofenadine HCI tablets
180 mg/antihistamine
24 HR
8 Gelcaps
Ndc 41167-4122-0allegra® Allergyfexofenadine Hci Tablets180 mg/antihistamine24 Hr8 Gelcaps (Allegra Gelcaps 01)
NDC 41167-4122-0
Allegra® Allergy
Fexofenadine HCI tablets
180 mg/antihistamine
24 HR
8 Gelcaps
PROFESSIONAL SAMPLE
NOT FOR RETAIL SALE
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