Cetirizine Hydrochloride by Caraco Pharmaceutical Laboratories, Ltd. / Sun Pharmaceutical Industries Limited

Cetirizine Hydrochloride by

Drug Labeling and Warnings

Cetirizine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by Caraco Pharmaceutical Laboratories, Ltd., Sun Pharmaceutical Industries Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet, film coated 
Sun Pharmaceutical Industries, Inc.

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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 children6 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 yearsand over:

  1 tablet once a day; do not take more than 1 tablet in; 24 hours;

• children under 6years of age:

  ask a doctor; ;

• consumers with liveror kidney disease:

  ask a doctor; ;

For 10 mg:

• adults and children6 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 yearsand over:

  ask a doctor; ;

• children under 6years of age:

  ask a doctor; ;

• consumers with liveror kidney disease:

  ask a doctor; ;

Other information

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

Questions or comments?

call toll free 1-800-818-4555 weekdays

Inactive Ingredients

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

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	Item Code (Source)	NDC: 57664-540
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)	CETIRIZINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57664-540-83	30 in 1 BOTTLE; Type 0: Not a Combination Product	12/27/2007	12/31/2015
2	NDC: 57664-540-88	100 in 1 BOTTLE; Type 0: Not a Combination Product	12/27/2007	12/31/2015
3	NDC: 57664-540-26	500 in 1 BOTTLE; Type 0: Not a Combination Product	12/27/2007	12/31/2015
4	NDC: 57664-540-27	1000 in 1 BOTTLE; Type 0: Not a Combination Product	12/27/2007	12/31/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077499	12/27/2007	12/31/2015

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57664-541
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
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57664-541-83	30 in 1 BOTTLE; Type 0: Not a Combination Product	12/27/2007	12/31/2015
2	NDC: 57664-541-88	100 in 1 BOTTLE; Type 0: Not a Combination Product	12/27/2007	12/31/2015
3	NDC: 57664-541-26	500 in 1 BOTTLE; Type 0: Not a Combination Product	12/27/2007	12/31/2015
4	NDC: 57664-541-27	1000 in 1 BOTTLE; Type 0: Not a Combination Product	12/27/2007	12/31/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077499	12/27/2007	12/31/2015

Labeler - Sun Pharmaceutical Industries, Inc. (146974886)

Revised: 12/2019

Document Id: 70fb7362-8d55-4883-8b99-55ad14e0cd29

34390-5

Set id: 0d46aa05-d4b7-4380-89e7-859b6ee221b4

Version: 3

Effective Time: 20191216