CETIRIZINE HYDROLORIDE ALLERGY- cetirizine hydroloride solution

Drug Facts
ACTIVE INGREDIENT

Active Ingredient (in each 5 mL teaspoonful)

Cetirizine hydrochloride, USP 5mg
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 DOCTOR

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
ASK DOCTOR/PHARMACIST

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

Stop use and ask 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 toll-free number 1-800-222-1222.

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	½ 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 age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Other information

Store between 20 to 25ºC (68 to 77ºF) or store refrigerated, 2 to 8ºC (36 to 46ºF)
Inactive ingredients

artificial grape flavor, glacial acetic acid, glycerin, methylparaben, purified water, propylene glycol, propylparaben, sodium acetate, and sucrose
Questions or comments?

call toll-free 1-800-818-4555 weekdays

Dosing Cup Included

Dosing cup should be washed and left to air dry after each use.

Do not use if carton is opened, or if seal on bottle is broken or missing.

Dist. by:      Caraco Pharmaceutical Laboratories, Ltd.

              Detroit, Michigan 48202

Mfg. by: SUN Pharmaceutical Industries, Inc.

              Bryan, Ohio 43506

6028L01                                          Iss: 09/11
Principal Display Panel
NDC: 57664-263-31

2 years & older

Children’s

Cetirizine

Hydrochloride

1mg / mL Oral Solution, USP

antihistamine

ALLERGY

Indoor and Outdoor Allergies

24 Hour Relief of
- Sneezing
- Runny Nose
- Itchy, Watery Eyes
- Itchy Throat or Nose
Dosing Cup Included

Do not use if carton is opened, or if seal on bottle is broken or missing.

2 years and older

Grape Syrup

4 fl. oz. (120 mL)

INGREDIENTS AND APPEARANCE

CETIRIZINE HYDROLORIDE ALLERGY
cetirizine hydroloride 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 slightly yellow)	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA091327	12/01/2011

Labeler - Caraco Pharmaceutical Laboratories, Ltd (146974886)

Registrant - Sun Pharmaceutical Industries Inc. (621283733)

Name	Address	ID/FEI	Business Operations
Establishment
Sun Pharmaceutical Industries Inc.		621283733	MANUFACTURE, ANALYSIS

CETIRIZINE HYDROLORIDE Allergy by