CHILDRENS FEXOFENADINE HYDROCHLORIDE  ALLERGY- fexofenadine hydrochloride suspension 
Taro Pharmaceuticals U.S.A., Inc.

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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)

Principal Display Panel - 120 mL Bottle Carton
CHILDRENS FEXOFENADINE HYDROCHLORIDE   ALLERGY
fexofenadine hydrochloride suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51672-2119
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)  
maltitol (UNII: D65DG142WK)  
poloxamer 407 (UNII: TUF2IVW3M2)  
propylene glycol (UNII: 6DC9Q167V3)  
propylparaben (UNII: Z8IX2SC1OH)  
water (UNII: 059QF0KO0R)  
sodium phosphate, dibasic, heptahydrate (UNII: 70WT22SF4B)  
sodium phosphate, monobasic, monohydrate (UNII: 593YOG76RN)  
sucralose (UNII: 96K6UQ3ZD4)  
titanium dioxide (UNII: 15FIX9V2JP)  
xanthan gum (UNII: TTV12P4NEE)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorRASPBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51672-2119-41 in 1 CARTON11/09/201711/17/2023
160 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:51672-2119-81 in 1 CARTON11/09/201711/17/2023
2120 mL in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:51672-2119-11 in 1 CARTON11/09/201711/17/2023
3240 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20812311/09/201711/17/2023
Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)

Revised: 11/2023
Document Id: 5ce855d4-cc38-4896-a8ac-5b8615d8741b
Set id: 0a78e6ec-ac9f-494e-9f7d-b1002fcad89c
Version: 5
Effective Time: 20231120
 
Taro Pharmaceuticals U.S.A., Inc.