CHILDRENS ALLERGY RELIEF- cetirizine hydrochloride solution

Active ingredient (in each 5 mL teaspoonful)

Cetirizine Hydrochloride USP 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

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 over	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

store between 20° to 25° C (68° to 77°F)
Inactive ingredients

banana flavor, glacial acetic acid, glycerin, grape flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate, sucrose
Questions?

call 248-449-9300

Distributed by:
C.D.M.A, Inc.©
43157 W.Nine Mile
Novi.MI 48376-0995
www.qualitychoice.com
Questions: 248-449-9300
PACKAGE LABEL- PRINCIPAL DISPLAY PANEL 4 FL OZ (120 mL Bottle)

NDC: 63868-865-04

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

Children's

Allergy
Relief

Indoor & Outdoor
Allergies

Cetirizine Hydrochloride
Oral Solution, USP 1mg/mL
Antihistamine

For Relief of:
Runny Nose | Sneezing
Itchy, Watery Eyes |
Itchy Nose or Throat

2 yrs. & older

Grape
Flavor

Dosing Cup
Included

4 FL OZ (120 mL)

INGREDIENTS AND APPEARANCE

CHILDRENS ALLERGY RELIEF
cetirizine hydrochloride solution

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)	CETIRIZINE HYDROCHLORIDE	1 mg in 1 mL

Product Characteristics
Color	YELLOW (Colorless to Pale Yellow)	Score
Shape		Size
Flavor	BANANA, GRAPE	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 63868-865-04	1 in 1 CARTON	11/20/2014
1		120 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA090750	11/20/2014

Labeler - C.D.M.A., Inc. (011920774)

Registrant - Aurohealth LLC (078728447)

Name	Address	ID/FEI	Business Operations
Establishment
Aurohealth LLC		078728447	MANUFACTURE(63868-865)

CHILDRENS ALLERGY RELIEF by