CHILDRENS CETIRIZINE HYDROCHLORIDE  SUGAR FREE GRAPE- cetirizine hydrochloride solution 
Taro Pharmaceuticals U.S.A., Inc.

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Children's Cetirizine Hydrochloride Oral Solution
Sugar Free Grape

Drug Facts

Active ingredient (in each 5 mL)

Cetirizine HCl 5 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 or to an antihistamine containing hydroxyzine.

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

When using this product

  • drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding

  • if breast-feeding: not recommended
  • if pregnant: 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 (1-800-222-1222).

Directions

adults and children 6 years and over5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours..
adults 65 years and older5 mL once daily; do not take more than 5 mL in 24 hours
children 2 to under 6 years of age2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every 12 hours. Do not give more than 5 mL in 24 hours.
children under 2 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor

Other information

Inactive ingredients

artificial grape flavor, glacial acetic acid, glycerin, methylparaben, natural and artificial banana flavor, propylene glycol, propylparaben, purified water, sodium acetate (anhydrous), sucralose

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 Zyrtec®*

NDC 51672-2102-8

Children's
Cetirizine
Hydrochloride
Oral Solution
1 mg/mL

ALLERGY
Antihistamine

Indoor & Outdoor Allergies

SUGAR FREE

24
Hour
Relief of:

2 Yrs. & older

Grape Flavor

Dosing Cup Included

4 FL OZ
(120 mL)

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton
CHILDRENS CETIRIZINE HYDROCHLORIDE   SUGAR FREE GRAPE
cetirizine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51672-2102
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Cetirizine Hydrochloride (UNII: 64O047KTOA) (Cetirizine - UNII:YO7261ME24) Cetirizine Hydrochloride1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
acetic acid (UNII: Q40Q9N063P)  
glycerin (UNII: PDC6A3C0OX)  
methylparaben (UNII: A2I8C7HI9T)  
propylene glycol (UNII: 6DC9Q167V3)  
propylparaben (UNII: Z8IX2SC1OH)  
water (UNII: 059QF0KO0R)  
sodium acetate anhydrous (UNII: NVG71ZZ7P0)  
sucralose (UNII: 96K6UQ3ZD4)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPE, BANANAImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51672-2102-41 in 1 CARTON09/08/2011
160 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:51672-2102-81 in 1 CARTON09/08/2011
2120 mL in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:51672-2102-11 in 1 CARTON09/08/2011
3240 mL in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:51672-2102-22 in 1 CARTON09/08/2011
4120 mL in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:51672-2102-72 in 1 CARTON09/08/2011
5240 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09018209/08/2011
Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceutical Industries, Ltd.600072078MANUFACTURE(51672-2102)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceuticals Inc.206263295MANUFACTURE(51672-2102)

Revised: 4/2021
Document Id: 590a6b63-2797-4ea3-a0c1-f69f68c4fae3
Set id: 54d72d7a-1f5b-4b36-bf76-ab7aef6243ab
Version: 5
Effective Time: 20210416
 
Taro Pharmaceuticals U.S.A., Inc.