CETIRIZINE HYDROCHLORIDE - cetirizine hydrochloride tablet, film coated
CETIRIZINE HYDROCHLORIDE - cetirizine hydrochloride tablet, film coated
Caraco Pharmaceutical Laboratories, Ltd.

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Drug Facts

Active ingredient (in each tablet)

For 5 mg:

Cetirizine hydrochloride 5 mg

For 10 mg:

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.

Directions

For 5 mg:

adults and children 6 years and over	1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours.
adults 65 years and over	1 tablet once a day; do not take more than 1 tablet in 24 hours
children under 6 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

For 10 mg:

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

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

Inactive ingredients corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, titanium dioxide

Questions or comments?

call toll free 1-800-818-4555 weekdays

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 5 mg 30 Tablets

NDC 57664-540-83

Cetirizine Hydrochloride Tablets, 5 mg

Antihistamine

ALLERGY

30 Tablets

Caraco Pharmaceutical Laboratories, Ltd.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 5 mg 30 Tablets

NDC 57664-540-83

Cetirizine Hydrochloride Tablets, 5 mg

Antihistamine

ALLERGY

30 Tablets

Caraco Pharmaceutical Laboratories, Ltd.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 10 mg 30 Tablets

NDC 57664-541-83

Cetirizine Hydrochloride Tablets, 10 mg

Antihistamine

ALLERGY

30 Tablets

Caraco Pharmaceutical Laboratories, Ltd.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 10 mg 30 Tablets

NDC 57664-541-83

Cetirizine Hydrochloride Tablets, 10 mg

Antihistamine

ALLERGY

30 Tablets

Caraco Pharmaceutical Laboratories, Ltd.

CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	NDC Product Code (Source)	57664-540
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE)	CETIRIZINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
POVIDONE
MAGNESIUM STEARATE
HYPROMELLOSE
POLYETHYLENE GLYCOL
POLYSORBATE 80
TITANIUM DIOXIDE

Product Characteristics
Color	WHITE (white)	Score	no score
Shape	ROUND (Barrel)	Size	7mm
Flavor		Imprint Code	540;C
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	57664-540-83	30 TABLET In 1 BOTTLE	None
2	57664-540-88	100 TABLET In 1 BOTTLE	None
3	57664-540-26	500 TABLET In 1 BOTTLE	None
4	57664-540-27	1000 TABLET In 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077499	12/27/2007

CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	NDC Product Code (Source)	57664-541
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE)	CETIRIZINE HYDROCHLORIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
POVIDONE
MAGNESIUM STEARATE
HYPROMELLOSE
POLYETHYLENE GLYCOL
POLYSORBATE 80
TITANIUM DIOXIDE

Product Characteristics
Color	WHITE (white)	Score	no score
Shape	ROUND (Barrel)	Size	9mm
Flavor		Imprint Code	541;C
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	57664-541-83	30 TABLET In 1 BOTTLE	None
2	57664-541-88	100 TABLET In 1 BOTTLE	None
3	57664-541-26	500 TABLET In 1 BOTTLE	None
4	57664-541-27	1000 TABLET In 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077499	12/27/2007

Labeler - Caraco Pharmaceutical Laboratories, Ltd. (146974886)

Establishment
Name	Address	ID/FEI	Operations
Caraco Pharmaceutical Laboratories, Ltd.		146974886	Manufacture, Analysis

Establishment
Name	Address	ID/FEI	Operations
Sun Pharmaceutical Industries Limited		650445203	Manufacture, Analysis

Revised: 11/2009Caraco Pharmaceutical Laboratories, Ltd.