Active Ingredient
(in each tablet)
Fexofenadine HCl 60 mg
(in each tablet)
Fexofenadine HCl 180 mg
(in each tablet)
Fexofenadine HCl 180 mg
Allegra Allergy Tablet, Film Coated
FDA Label NDC 41167-4124
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 41167-4124). 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, 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
Antihistamine
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
- runny nose
- sneezing
- itchy, water eyes
- itching of the nose or throat
- runny nose
- sneezing
- itchy, water eyes
- itching of the nose or throat
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
Do Not Use
if you have ever had an allergic reaction to this product or any of its ingredients
if you have ever had an allergic reaction to this product or any of its ingredients
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.
kidney disease. Your doctor should determine if you need a different dose.
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)
- 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)
- 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.
an allergic reaction to this product occurs. Seek medical help right away.
an allergic reaction to this product occurs. Seek medical help right away.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
ask a health professional before use.
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.
In case of overdose, get medical help or contact a Poison Control Center right away.
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 60 mg tablet with water every 12 hours; do not take more than 2 tablets 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 |
| 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 |
| 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
- safety sealed: do not use if carton is opened or if printed foil inner seal on bottle is torn or missing
- store between 20° and 25°C (68° and 77°F)
- protect from excessive moisture
- 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
colloidal silicone dioxide, croscarmellose sodium, hypromellose, iron oxide blends, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, titanium dioxide
colloidal silicone dioxide, croscarmellose sodium, hypromellose, iron oxide blends, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, titanium dioxide
colloidal silicone dioxide, croscarmellose sodium, hypromellose, iron oxide blends, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, titanium dioxide
Questions or comments?
call toll-free 1-800-633-1610 or www.allegra.com
Questions Or Comments?
call toll-free 1-800-633-1610 or www.allegra.com
Allegra Allergy® - 24 HOUR
Drug Facts
call toll-free 1-800-633-1610 or www.allegra.com
Allegra Allergy® - 24 HOUR
Drug Facts
Principal Display Panel
NDC 41167-4120-2
Allegra® Allergy
fexofenadine HCl tablet 180 mg/antihistamine
Indoor and Outdoor Allergies
15 Tablets
24 HOUR
Principal Display Panelndc 41167-4120-2allegra® Allergyfexofenadine HCl Tablet 180 mg/antihistamineindoor And Outdoor Allergies15 Tablets24 Hour (Allegra Allergy 01)
NDC 41167-4120-3
Allegra®
Allergy
fexofenadine HCl tablet
180 mg/antihistamine 24 HOUR
Indoor and Outdoor Allergies
30 Tablets
Ndc 41167-4120-3allegra® Allergyfexofenadine HCl Tablet 180 mg/antihistamine 24 Hourindoor And Outdoor Allergies30 Tablets (Allegra Allergy 02)
NDC 41167-4131-2
Allegra® Allergy
fexofenadine HCl tablet 60 mg/antihistamine
Indoor and Outdoor Allergies
12 Tablets
12 HOUR
Ndc 41167-4131-2allegra® Allergyfexofenadine HCl Tablet 60 mg/antihistamineindoor And Outdoor Allergies12 Tablets 12 Hour (Allegra Allergy 03)
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