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

----------

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)

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.

Cetirizine hydrochloride-5 mg

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.

Cetirizine hydrochloride-5 mg

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-10 mg

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-10 mg
CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57664-540
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITE (white) Scoreno score
ShapeROUND (Barrel) Size7mm
FlavorImprint Code 540;C
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57664-540-8330 in 1 BOTTLE; Type 0: Not a Combination Product12/27/200712/31/2015
2NDC:57664-540-88100 in 1 BOTTLE; Type 0: Not a Combination Product12/27/200712/31/2015
3NDC:57664-540-26500 in 1 BOTTLE; Type 0: Not a Combination Product12/27/200712/31/2015
4NDC:57664-540-271000 in 1 BOTTLE; Type 0: Not a Combination Product12/27/200712/31/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07749912/27/200712/31/2015
CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57664-541
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITE (white) Scoreno score
ShapeROUND (Barrel) Size9mm
FlavorImprint Code 541;C
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57664-541-8330 in 1 BOTTLE; Type 0: Not a Combination Product12/27/200712/31/2015
2NDC:57664-541-88100 in 1 BOTTLE; Type 0: Not a Combination Product12/27/200712/31/2015
3NDC:57664-541-26500 in 1 BOTTLE; Type 0: Not a Combination Product12/27/200712/31/2015
4NDC:57664-541-271000 in 1 BOTTLE; Type 0: Not a Combination Product12/27/200712/31/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07749912/27/200712/31/2015
Labeler - Sun Pharmaceutical Industries, Inc. (146974886)

Revised: 12/2019
Document Id: 70fb7362-8d55-4883-8b99-55ad14e0cd29
Set id: 0d46aa05-d4b7-4380-89e7-859b6ee221b4
Version: 3
Effective Time: 20191216
 
Sun Pharmaceutical Industries, Inc.