CHILDRENS CETIRIZINE HYDROCHLORIDE SUGAR FREE GRAPE- cetirizine hydrochloride solution

Childrens Cetirizine Hydrochloride by

Drug Labeling and Warnings

Childrens Cetirizine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by Taro Pharmaceuticals U.S.A., Inc., Taro Pharmaceutical Industries, Ltd., Taro Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient (in each 5 mL)

Cetirizine HCl 5 mg

Purpose

Antihistamine

Uses

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

• runny nose
• itchy, watery eyes
• sneezing
• 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 (1-800-222-1222).

Directions

• use only with enclosed dosing cup
• find right dose on chart below
• mL = milliliter

• adults and children 6 years and over: 5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours..
• adults 65 years and older: 5 mL once daily; do not take more than 5 mL in 24 hours
• children 2 to under 6 years of age: 2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every 12 hours. Do not give more than 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

• do not use if carton is opened, or if imprinted safety seal is broken or missing
• see bottom panel for expiration date
• store between 20° to 25°C (68° to 77°F)

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

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Distributed by: Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

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

NDC: 51672-2102-8

Children's
Cetirizine
Hydrochloride
Oral Solution
1 mg/mL ALLERGY
Antihistamine

Indoor & Outdoor Allergies

SUGAR FREE

24
Hour
Relief of:

• Sneezing
• Runny Nose
• Itchy, Watery Eyes
• Itchy Throat or Nose

2 Yrs. & older

Grape Flavor

Dosing Cup Included

4 FL OZ
(120 mL)

INGREDIENTS AND APPEARANCE

CHILDRENS CETIRIZINE HYDROCHLORIDE   SUGAR FREE GRAPE
cetirizine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51672-2102
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
acetic acid (UNII: Q40Q9N063P)
glycerin (UNII: PDC6A3C0OX)
methylparaben (UNII: A2I8C7HI9T)
propylene glycol (UNII: 6DC9Q167V3)
propylparaben (UNII: Z8IX2SC1OH)
water (UNII: 059QF0KO0R)
sodium acetate anhydrous (UNII: NVG71ZZ7P0)
sucralose (UNII: 96K6UQ3ZD4)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE, BANANA	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51672-2102-4	1 in 1 CARTON	09/08/2011
1		60 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 51672-2102-8	1 in 1 CARTON	09/08/2011
2		120 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 51672-2102-1	1 in 1 CARTON	09/08/2011
3		240 mL in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 51672-2102-2	2 in 1 CARTON	09/08/2011
4		120 mL in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 51672-2102-7	2 in 1 CARTON	09/08/2011
5		240 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090182	09/08/2011

Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)

Establishment
Name	Address	ID/FEI	Business Operations
Taro Pharmaceutical Industries, Ltd.		600072078	MANUFACTURE(51672-2102)

Establishment
Name	Address	ID/FEI	Business Operations
Taro Pharmaceuticals Inc.		206263295	MANUFACTURE(51672-2102)