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Cetirizine Hydrochloride by Caraco Pharmaceutical Laboratories, Ltd.

Medically reviewed on January 5, 2018

Dosage form: tablet, film coated
Ingredients: CETIRIZINE HYDROCHLORIDE 5mg
Labeler: Caraco Pharmaceutical Laboratories, Ltd.
NDC Code: 57664-540

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:57664-540
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
STARCH, CORN 
POVIDONE 
MAGNESIUM STEARATE 
HYPROMELLOSE 
POLYETHYLENE GLYCOL 
POLYSORBATE 80 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITE (white) Scoreno score
ShapeROUND (Barrel) Size7mm
FlavorImprint Code540;C
Contains    
Packaging
#Item CodePackage Description
1NDC:57664-540-8330 TABLET, FILM COATED (30 TABLET) in 1 BOTTLE
2NDC:57664-540-88100 TABLET, FILM COATED (100 TABLET) in 1 BOTTLE
3NDC:57664-540-26500 TABLET, FILM COATED (500 TABLET) in 1 BOTTLE
4NDC:57664-540-271000 TABLET, FILM COATED (1000 TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07749912/27/2007
CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57664-541
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
STARCH, CORN 
POVIDONE 
MAGNESIUM STEARATE 
HYPROMELLOSE 
POLYETHYLENE GLYCOL 
POLYSORBATE 80 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITE (white) Scoreno score
ShapeROUND (Barrel) Size9mm
FlavorImprint Code541;C
Contains    
Packaging
#Item CodePackage Description
1NDC:57664-541-8330 TABLET, FILM COATED (30 TABLET) in 1 BOTTLE
2NDC:57664-541-88100 TABLET, FILM COATED (100 TABLET) in 1 BOTTLE
3NDC:57664-541-26500 TABLET, FILM COATED (500 TABLET) in 1 BOTTLE
4NDC:57664-541-271000 TABLET, FILM COATED (1000 TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07749912/27/2007
Labeler - Caraco Pharmaceutical Laboratories, Ltd. (146974886)
Establishment
NameAddressID/FEIOperations
Caraco Pharmaceutical Laboratories, Ltd.146974886Manufacture, Analysis
Establishment
NameAddressID/FEIOperations
Sun Pharmaceutical Industries Limited725959238Manufacture, Analysis

 
Caraco Pharmaceutical Laboratories, Ltd.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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