PREMIER VALUE  CHILDRENS CETIRIZINE- cetirizine hydrochloride solution 
Chain Drug Constortium

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Premier Value
Children's Cetirizine

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

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 CHAIN DRUG CONSORTIUM
3301 NW BOCA RATON BLVD, SUITE 101
BOCA RATON, FL 33431

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

NDC 68016-165-00

COMPARE TO THE
ACTIVE INGREDIENT
IN CHILDREN'S ZYRTEC®*

Premier
Value

Ages
two years
and older

Children's
Cetirizine
Hydrochloride
Oral Solution
1 mg/mL

Antihistamine

SUGAR FREE
GRAPE
flavor

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

INDOOR & OUTDOOR
ALLERGIES

Dosing Cup
Included

INDEPENDENTLY TESTED
P
V

SATISFACTION GUARANTEED

4 FL OZ
(120 mL)

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton
PREMIER VALUE   CHILDRENS CETIRIZINE
cetirizine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:68016-165
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Cetirizine Hydrochloride (Cetirizine) Cetirizine Hydrochloride5 mg  in 5 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
FlavorGRAPE (sugar free) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-165-001 in 1 CARTON
1120 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09018209/08/2011
Labeler - Chain Drug Constortium (101668460)
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceutical Industries Ltd.600072078MANUFACTURE(68016-165)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceuticals Inc.206263295MANUFACTURE(68016-165)

Revised: 1/2013
Document Id: 14c79f37-d5eb-46d3-be2a-a2ddda06be9a
Set id: a4931f0b-86f2-42c5-b2df-b359bb46f44a
Version: 2
Effective Time: 20130124
 
Chain Drug Constortium