CHILDRENS ALLEGRA ALLERGY- fexofenadine hydrochloride tablet, orally disintegrating 
Chattem, Inc.

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Childrens Allegra Allergy-ODT

Drug Facts

Active ingredient

(in each tablet)

Fexofenadine HCI 30 mg

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

Warnings

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

  • place 1 tablet on tongue; tablet disintegrates, with or without water
adults and children 12 years of age and overtake 2 tablets every 12 hours on an empty stomach; do not take more than 4 tablets in 24 hours
children 6 to under 12 years of agetake 1 tablet every 12 hours on an empty stomach; do not take more than 2 tablets in 24 hours
children under 6 years of agedo not use
adults 65 years of age and olderask a doctor
consumers with kidney diseaseask a doctor

Other information

  • each tablet contains: sodium 5 mg
  • phenylketonurics: contains phenylalanine 5.3 mg per tablet
  • safety sealed: do not use if carton is opened or if individual blister units are torn or opened
  • store between 20º and 25ºC (68º and 77ºF)
  • use tablet immediately after opening individual blister

Inactive ingredients

aspartame, citric acid anhydrous, crospovidone, flavors, magnesium stearate, mannitol, methacrylic acid copolymer, microcrystalline cellulose, povidone, sodium bicarbonate, sodium starch glycolate

Questions or comments?

call toll-free 1-800-633-1610 or www.allegra.com 

Dist. By: Chattem, Inc.(part of the sanofi-aventis Group),

Chattanooga, TN 37409-0219 ©2010             50094020

PRINCIPAL DISPLAY PANEL

NDC 41167-4233-3
ORIGINAL PRESCRIPTION STRENGTH
NON-DROWSY
Children’s
Allegra®
Allergy
fexofenadine HCl orally disintegrating
tablets mg/antihistamine
30 mg
Indoor and Outdoor Allergies
Orange Cream flavored
12 Orally Disintegrating Tablets 30 mg each

PRINCIPAL DISPLAY PANEL NDC 41167-4233-3 ORIGINAL PRESCRIPTION STRENGTH NON-DROWSY Children’s Allegra® Allergy fexofenadine HCl orally disintegrating tablets mg/antihistamine 30 mg Indoor and Outdoor Allergies Orange Cream flavored 12 Orally Disintegrating Tablets 30 mg each

CHILDRENS ALLEGRA ALLERGY 
fexofenadine hydrochloride tablet, orally disintegrating
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:41167-4233
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) FEXOFENADINE HYDROCHLORIDE30 mg
Inactive Ingredients
Ingredient NameStrength
ASPARTAME 
ANHYDROUS CITRIC ACID 
CROSPOVIDONE 
MAGNESIUM STEARATE 
MANNITOL 
CELLULOSE, MICROCRYSTALLINE 
POVIDONE 
SODIUM BICARBONATE 
Product Characteristics
ColorWHITEScoreno score
ShapeOVAL (round with beveled edges) Size13mm
FlavorORANGE (Orange Cream) Imprint Code e;311;AV
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41167-4233-32 in 1 CARTON
16 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02190903/03/2011
Labeler - Chattem, Inc. (003336013)

Revised: 7/2011
Document Id: da976b05-33e0-4e74-9d82-f12d37934ab7
Set id: f5eb861f-0ebd-4d37-a62a-5fecde4c65bd
Version: 5
Effective Time: 20110702
 
Chattem, Inc.