CHILDRENS CETIRIZINE HYDROCHLORIDE - cetirizine hydrochloride solution 
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

CHILDRENS CETIRIZINE HYDROCHLORIDE  cetirizine hydrochloride   solution

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 68094-720 (0113-0974) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Cetirizine Hydrochloride (Cetirizine) Cetirizine Hydrochloride 5 mg  in 5 mL

Inactive Ingredients Ingredient Name Strength Acetic Acid   glycerin   methylparaben   propylene glycol   propylparaben   sodium acetate   sucrose   water

Product Characteristics Color      Score      Shape Size Flavor GRAPE Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 68094-720-62 3 TRAY In 1 CASE contains a TRAY 1 10 CUP In 1 TRAY This package is contained within the CASE (68094-720-62) and contains a CUP, UNIT-DOSE (68094-720-59) 1 68094-720-59 5 mL In 1 CUP, UNIT-DOSE This package is contained within a TRAY and a CASE (68094-720-62)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090254	03/17/2009

Labeler - Precision Dose Inc. (035886746)

Revised: 11/2010Precision Dose Inc.