CHILDRENS CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride liquid 
Precision Dose Inc.

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CHILDREN'S CETIRIZINE
HYDROCHLORIDE ORAL SOLUTION

5 mg/5 mL

Grape Flavor

For Hospital Use Only

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
  • sneezing
  • itchy, watery eyes
  • 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.

Directions

  • use as directed per healthcare professional

Other information

  • store between 20° - 25°C (68° - 77°F)
  • See individual label or shipper label for lot number and expiration date.

Inactive ingredients

acetic acid, artificial grape flavor, glycerin, methylparaben, natural banana flavor, propylene glycol, propylparaben, sodium acetate, sucrose, water

How Supplied

NDC 68094-720-62
5 mL per unit dose cup
Thirty (30) unit dose cups per shipper

Distributed By:
Perrigo Company
515 Eastern Avenue
Allegan, MI 49010

Packaged By:
Precision Dose, Inc.
722 Progressive Lane
S. Beloit, IL 61080

LI722
Rev. 12/08

PRINCIPAL DISPLAY PANEL - 5 mg/5 mL Cup Lid Label

NDC 68094-720-59

PrecisionDose™

Children's CETIRIZINE HCl
Oral Solution
5 mg/5 mL

Pkg: Precision Dose, Inc., S. Beloit, IL 61080

PRINCIPAL DISPLAY PANEL - 5 mg/5 mL Cup Lid Label
CHILDRENS CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68094-720(NDC:0113-0974)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Cetirizine Hydrochloride (UNII: 64O047KTOA) (Cetirizine - UNII:YO7261ME24) Cetirizine Hydrochloride5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
acetic acid (UNII: Q40Q9N063P)  
glycerin (UNII: PDC6A3C0OX)  
methylparaben (UNII: A2I8C7HI9T)  
propylene glycol (UNII: 6DC9Q167V3)  
propylparaben (UNII: Z8IX2SC1OH)  
sodium acetate (UNII: 4550K0SC9B)  
sucrose (UNII: C151H8M554)  
water (UNII: 059QF0KO0R)  
Product Characteristics
ColorYELLOW (Pale Yellow) Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68094-720-623 in 1 CASE03/17/200908/31/2017
110 in 1 TRAY
1NDC:68094-720-595 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09025403/17/200908/31/2017
Labeler - Precision Dose Inc. (035886746)

Revised: 3/2017
Document Id: 060ef673-b392-47f0-a246-0d0b598ee92a
Set id: 6606a288-acb6-4bee-ac6f-6ceeec3fb666
Version: 4
Effective Time: 20170321
 
Precision Dose Inc.