CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride solution 
Taro Pharmaceutical Industries, Ltd.

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Children's
Cetirizine
Hydrochloride
Oral Solution

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 breastfeeding: 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

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

Dosing cup should be washed and left to air dry after each use. Do not use if carton is opened or if imprinted safety seal is torn or missing.

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

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

NDC 51672-2106-8

Children's
Cetirizine
Hydrochloride
Oral Solution

1 mg/mL
Antihistamine

ALLERGY
Indoor & Outdoor Allergies

2 Yrs.
& older

Dye Free
Sugar Free
Bubble Gum Flavor

24
Hour

Relief of:

4 FL OZ (118 mL)

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label
CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52549-2106
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
ColorYELLOW (colorless to slightly yellow) Score    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52549-2106-81 in 1 CARTON
1118 mL in 1 BOTTLE
2NDC:52549-2106-11 in 1 CARTON
2237 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20154605/20/2011
Labeler - Taro Pharmaceutical Industries, Ltd. (600072078)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceutical Industries, Ltd.600072078MANUFACTURE

Revised: 7/2011
Document Id: 5ce3ebe2-4297-4a70-b32f-cdd74c462e49
Set id: 490e395b-bd03-49f1-9abc-2f060138d321
Version: 1
Effective Time: 20110711
 
Taro Pharmaceutical Industries, Ltd.