OTC Medication Information: Childrens Allergy

CHILDRENS ALLERGY- fexofenadine hydrochloride suspension
H E B

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:

  • runny nose
  • sneezing
  • itchy, watery 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 (1-800-222-1222) right away.

Direction

  • shake well before using
  • use only with enclosed dosing cup

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 age take 5 mL every 12 hours; do not take more than 10 mL in 24 hours
children under 2 years of age ask a doctor
adults 65 years of age and older ask a doctor
consumers with kidney disease ask a doctor


Note: mL = mililiters

Other information

  • each 5 mL contains: sodium 18 mg
  • store between 20º to 25ºC (68º to 77ºF)
  • before using any medication, read all label directions. Keep carton, it contain important 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:

  • Sneezing
  • Runny nose
  • Runny nose
  • Itchy, watery eyes
  • Itchy nose or throat

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
(click image for full-size original)

H-E-B Children’s Allergy Berry Flavor

CHILDRENS ALLERGY
fexofenadine hcl suspension
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:37808-623
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) FEXOFENADINE HYDROCHLORIDE 30 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
BUTYLPARABEN
EDETATE DISODIUM
POLOXAMER 407
PROPYLENE GLYCOL
PROPYLPARABEN
WATER
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS
SUCROSE
TITANIUM DIOXIDE
XANTHAN GUM
XYLITOL
Product Characteristics
Color Score
Shape Size
Flavor BERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:37808-623-04 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 118 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (37808-623-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203330 04/30/2021
Labeler — H E B (007924756)

Revised: 06/2023 H E B

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2024. All Rights Reserved.