CETIRIZINE HYDROCHLORIDE tablet

Cetirizine Hydrochloride by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

Cetirizine Hydrochloride 10 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. (1-800-222-1222)

Directions

• adults and children 6 years and over: one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.
• adults 65 years and over: ask a doctor
• children under 6 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 inner safety seal on bottle is broken or missing
• store between 20° to 25°C (68° to 77°F)
• for lot number and expiry date see carton or bottle label.

Inactive ingredients

corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, and titanium dioxide.

Questions?

Call 1-866-923-4914

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Carton

Compare to the
active ingredient
in Zyrtec®*

NDC: 51672-2097-1

Cetirizine
Hydrochloride
Tablets 10 mg
Antihistamine

ALLERGY

Indoor & Outdoor Allergies

24
Hour
Relief of:

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

100
Tablets
10 mg each

INGREDIENTS AND APPEARANCE

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51672-2097
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Cetirizine Hydrochloride (UNII: 64O047KTOA) (Cetirizine - UNII:YO7261ME24)	Cetirizine Hydrochloride	10 mg

Inactive Ingredients
Ingredient Name	Strength
starch, corn (UNII: O8232NY3SJ)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
lactose monohydrate (UNII: EWQ57Q8I5X)
magnesium stearate (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
titanium dioxide (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND (biconvexed)	Size	8mm
Flavor		Imprint Code	CT;10
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51672-2097-1	1 in 1 CARTON	07/22/2009
1		100 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	ANDA078072	07/22/2009

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

Establishment
Name	Address	ID/FEI	Business Operations
Taro Pharmaceuticals Industries Ltd.		600072078	MANUFACTURE(51672-2097)