CHILDRENS ALLERGY- fexofenadine hcl suspension 
H E B

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DRUG FACTS

Active ingredient (in each 5 mL)

Fexofenadine HCl, USP 30 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

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 (1-800-222-1222) right away.

Direction

adults and children 12 years of age and over

take 10 mL every 12 hours: do not take more than 20 mL in 24 hours
children 2 to under 12 years of agetake 5 mL every 12 hours; do not take more than 10 mL in 24 hours
children under 2 years of ageask a doctor
adults 65 years of age and olderask a doctor
consumers with kidney diseaseask a doctor


Note: mL = mililiters

Other information

Inactive ingredients

artificial raspberry flavor, butylparaben, edetate disodium, poloxamer 407, propylene glycol, propylparaben, purified water, sodium phosphate dibasic, sodium phosphate, monobasic, sucrose, titanium dioxide, xanthan gum, xylitol

Questions or comments?

Call toll free: 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to Children's Allegra® Allergy active ingredient**

Childrens

ALLERGY

Fexofenadine HCl

Oral Suspension 30 mg/5mL

Antihistamine

Allergy Relief

Alcohol Free

Dye Free

Non-Drowsy

For Ages 2 years and Over

12 HOUR

Indoor/Outdoor Relief of:

Berry Flavor

FL OZ (mL)

Use only with enclosed dosing cup. Wash and let air dry after each use.

*This product is not manufactured or distributed by Chattem Inc., distributor of  Children's Allegra® Allergy.

TAMPER EVIDENT: DO NOT USE IF CARTON, UNPRINTED FOIL INNER SEAL, OR NECKBAND PRINTED WITH "SEALED FOR YOUR PROTECTION" IS OPENED TORN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

MADE WITH PRIDE AND CARE FOR H-E-B®

SAN ANTONIO, TX 78204


Product Label

Fexofenadine HCl, USP 30 mg

H-E-B Children's Allergy Berry Flavor

CHILDRENS ALLERGY 
fexofenadine hcl suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-623
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE30 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)  
SUCROSE (UNII: C151H8M554)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
XANTHAN GUM (UNII: TTV12P4NEE)  
XYLITOL (UNII: VCQ006KQ1E)  
Product Characteristics
Color    Score    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37808-623-041 in 1 CARTON04/30/2021
1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20333004/30/2021
Labeler - H E B (007924756)

Revised: 6/2023
Document Id: bd3099ea-673c-4145-96b1-8ca6cf21bde1
Set id: 3b6f4a4b-b1bd-4062-9e7f-571b836b1536
Version: 2
Effective Time: 20230607
 
H E B