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Childrens Fexofenadine Hydrochloride Allergy

Dosage form: suspension
Ingredients: Fexofenadine Hydrochloride 30mg in 5mL
Labeler: Taro Pharmaceuticals U.S.A., Inc.
NDC Code: 51672-2119

Children's Fexofenadine Hydrochloride
Allergy

Drug Facts

Active ingredient (in each 5 mL)

Fexofenadine HCl 30 mg

Purpose

Antihistamine

Uses

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

  • runny nose
  • itchy, watery eyes
  • sneezing
  • 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
  • shake well before using
  • use only with enclosed dosing cup
Note: mL = milliliters
adults and children 12 years of age and overtake 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

Other information
  • each 5 mL contains: sodium 9 mg
  • safety sealed: do not use if carton is opened or if foil inner seal on bottle is torn or missing
  • store between 20° and 25°C (68° and 77°F)

Inactive ingredients

artificial raspberry flavor, butylparaben, edetate disodium, maltitol solution, poloxamer 407, propylene glycol, propylparaben, purified water, sodium phosphate dibasic heptahydrate, sodium phosphate monobasic monohydrate, sucralose, titanium dioxide and xanthan gum

Questions?

Call 1-866-923-4914

Distributed by:
Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

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

NDC 51672-2119-8

Children's
Allergy
Fexofenadine HCl
Oral Suspension,
30 mg/ 5 mL
Antihistamine

NON-DROWSY

12
Hour

Berry Flavor

2
Years
& Older

INDOOR/OUTDOOR
ALLERGY RELIEF

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Nose or Throat

Dye free / Alcohol free / Sugar free

LIQUID
Oral Suspension

4 fl. oz.
(120 mL)

CHILDRENS FEXOFENADINE HYDROCHLORIDE   ALLERGY
fexofenadine hydrochloride suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51672-2119
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Fexofenadine Hydrochloride (Fexofenadine) Fexofenadine Hydrochloride30 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
butylparaben 
edetate disodium 
maltitol 
poloxamer 407 
propylene glycol 
propylparaben 
water 
sodium phosphate, dibasic, heptahydrate 
sodium phosphate, monobasic, monohydrate 
sucralose 
titanium dioxide 
xanthan gum 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorRASPBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:51672-2119-41 BOTTLE in 1 CARTON
160 mL in 1 BOTTLE
2NDC:51672-2119-81 BOTTLE in 1 CARTON
2120 mL in 1 BOTTLE
3NDC:51672-2119-11 BOTTLE in 1 CARTON
3240 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20812311/09/2017
Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)

Revised: 11/2017
 
Taro Pharmaceuticals U.S.A., Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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