CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride solution 
Taro Pharmaceuticals U.S.A., Inc.

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Children's
Cetirizine
Hydrochloride
Oral Solution

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:

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 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

Inactive ingredients

bubble gum artificial flavor, glacial acetic acid, glycerin, methylparaben, 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 51672-2106-8

Children's
Cetirizine
Hydrochloride
Oral Solution

1 mg/mL
Antihistamine

ALLERGY

Indoor & Outdoor Allergies

SUGAR FREE

24
Hour

Relief of:

2 Yrs. & older

Bubble
Gum
Flavor

Dosing Cup
Included

4 FL OZ
(120 mL)

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton
CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:51672-2106
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
ColorYELLOW (colorless to slightly yellow) Score    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51672-2106-81 in 1 CARTON
1120 mL in 1 BOTTLE
2NDC:51672-2106-11 in 1 CARTON
2240 mL in 1 BOTTLE
3NDC:51672-2106-41 in 1 CARTON
360 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20154605/20/2011
Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceutical Industries, Ltd.600072078MANUFACTURE(51672-2106)

Revised: 8/2013
Document Id: e409baed-c061-46a6-b747-92b3c42087fb
Set id: 67207357-5f8a-4424-9901-d2717a43cf1b
Version: 3
Effective Time: 20130826
 
Taro Pharmaceuticals U.S.A., Inc.