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

  • phenylketonurics: contains phenylalanine 3.8 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
  • contains lactose

Inactive ingredients

aspartame, crospovidone, flavors, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, povidone, silicon dioxide

Questions or comments?

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

Dist. By: Chattem, Inc, a Sanofi Company,

Chattanooga, TN 37409-0219 ©2015

PRINCIPAL DISPLAY PANEL

NDC 41167-4232-1
NON-DROWSY
Children’s
Allegra® 
Allergy
fexofenadine HCl orally disintegrating
tablet 30 mg/antihistamine
Indoor and Outdoor Allergies
Orange Cream flavor
12 Orally Disintegrating Tablets

NDC 41167-4232-1 NON-DROWSY Children’s Allegra® Allergy fexofenadine HCl orally disintegrating tablet 30 mg/antihistamine Indoor and Outdoor Allergies Orange Cream flavor 12 Orally Disintegrating Tablets

PRINCIPAL DISPLAY PANEL

NDC 41167-4232-6
NON-DROWSY
Children’s
Allegra® 
Allergy
fexofenadine HCl orally disintegrating
tablet 30 mg/antihistamine
Indoor and Outdoor Allergies
Orange Cream flavor
24 Orally Disintegrating Tablets

NDC 41167-4232-6 NON-DROWSY Children’s Allegra® Allergy fexofenadine HCl orally disintegrating tablet 30 mg/antihistamine Indoor and Outdoor Allergies Orange Cream flavor 24 Orally Disintegrating Tablets

CHILDRENS ALLEGRA ALLERGY 
fexofenadine hydrochloride tablet, orally disintegrating
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-4233
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE30 mg
Inactive Ingredients
Ingredient NameStrength
ASPARTAME (UNII: Z0H242BBR1)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:2) (UNII: XRK36F13ZZ)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
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 CARTON03/03/201101/02/2018
16 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02190903/03/201101/02/2018
Labeler - Chattem, Inc. (003336013)

Revised: 8/2023
Document Id: fbd9ee93-eda3-41be-8bea-0c161d2345f0
Set id: f5eb861f-0ebd-4d37-a62a-5fecde4c65bd
Version: 15
Effective Time: 20230825
 
Chattem, Inc.