CHILDRENS CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride solution 
Chain Drug Consortium, LLC (Premier Value)

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CHILDREN'S
CETIRIZINE
HYDROCHLORIDE
ORAL SOLUTION
1 mg/1 mL
Antihistamine

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.

Directions

adults and children 6 years and over 1 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 older 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours.
children 2 to under 6 years of age 1/2 teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or 1/2 teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours.
children under 2 years of age ask a doctor
consumers with liver or kidney disease ask 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), sucrose

Questions?

Call 1-866-923-4914

Distributed by: Chain Drug Consortium, LLC
2300 NW Corporate BLVD., Suite 115
Boca Raton, FL 33431
Made in Israel

PRINCIPAL DISPLAY PANEL - 120 mL bottle carton

NDC 68016-023-43

Ages
two years
and older

Compare to
the active ingredient
in Children's Zyrtec®*

Premier
Value
®

CHILDREN'S
CETIRIZINE
HYDROCHLORIDE
ORAL SOLUTION
1 mg/1 mL
Antihistamine

Grape Flavored Syrup

24 hour Allergy Relief of:
Sneezing; Runny Nose;
Itchy,Watery Eyes;
Itchy Throat or Nose

Indoor & Outdoor Allergies

Dosing Cup
Included

PV
PREMIER VALUE GUARANTEE

4 FL OZ (120 mL)

Principal Display Panel - 120 mL bottle carton
CHILDRENS CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-023
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Cetirizine Hydrochloride (UNII: 64O047KTOA) (Cetirizine - UNII:YO7261ME24) Cetirizine Hydrochloride 5 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
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)  
sucrose (UNII: C151H8M554)  
Product Characteristics
Color YELLOW (colorless to slightly yellow) Score     
Shape Size
Flavor GRAPE, BANANA Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68016-023-43 1 in 1 CARTON
1 120 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090182 04/22/2008
Labeler - Chain Drug Consortium, LLC (Premier Value) (101668460)
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
Name Address ID/FEI Business Operations
Taro Pharmaceutical Industries Ltd. 600072078 ANALYSIS, MANUFACTURE

Revised: 4/2010
Document Id: 82a61a5f-5cb3-4b5e-b039-345d5fd46478
Set id: b47b0c8b-59d5-4e17-95be-a992c6861ee7
Version: 1
Effective Time: 20100421
 
Chain Drug Consortium, LLC (Premier Value)