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

----------

Drug Facts

Active ingredient (in each 5 mL teaspoonful)

Cetirizine HCl 5 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 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

  • use only with enclosed dosing cup
adults and children 6 years and over1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours.
adults 65 years and older1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours.
children 2 to under 6 years of age½ teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or ½ teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours.
children under 2 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor

Other information

  • store between 20° to 25°C (68° to 77°F)

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:

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

2 Yrs. & older

Dosing Cup
Included

Grape
Flavor

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 AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Cetirizine Hydrochloride (Cetirizine) Cetirizine Hydrochloride1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
acetic acid 
glycerin 
methylparaben 
propylene glycol 
propylparaben 
water 
sodium acetate anhydrous 
sucralose 
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPE, BANANAImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:51672-2102-41 in 1 CARTON
160 mL in 1 BOTTLE
2NDC:51672-2102-81 in 1 CARTON
2120 mL in 1 BOTTLE
3NDC:51672-2102-11 in 1 CARTON
3240 mL in 1 BOTTLE
4NDC:51672-2102-22 in 1 CARTON
4120 mL in 1 BOTTLE
5NDC:51672-2102-72 in 1 CARTON
5240 mL in 1 BOTTLE
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)

Revised: 06/2012
Document Id: 6701800d-3457-4580-a2b2-2e604a2457de
Set id: 54d72d7a-1f5b-4b36-bf76-ab7aef6243ab
Version: 1
Effective Time: 20120605
 
Taro Pharmaceuticals U.S.A., Inc.