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cetirizine hydrochloride by Unichem Pharmaceuticals (USA), Inc.

Dosage form: tablet, film coated
Ingredients: CETIRIZINE HYDROCHLORIDE 5mgCETIRIZINE HYDROCHLORIDE 10mg
Labeler: Unichem Pharmaceuticals (USA), Inc.
NDC Code: 29300-133

Cetirizine Hydrochloride Tablets USP

DRUG FACTS

ACTIVE INGREDIENT

(IN EACH TABLET)

For 5 mg

Cetirizine Hydrochloride USP, 5 mg

For 10 mg

Cetirizine Hydrochloride USP, 10 mg

PURPOSE

Antihistamine

INDICATIONS AND USAGE

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)

DOSAGE AND ADMINISTRATION

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

STORAGE AND HANDLING
  • store between 20oto 25oC (68o to 77oF)

INACTIVE INGREDIENT

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

QUESTIONS

call 1-866-562-4616 from Monday to Friday between 8.00 Am to 8.00 PM, EST

Manufactured by:

UNICHEM LABORATORIES LTD.

Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India.

Manufactured for:

Hasbrouck Heights, NJ 07604.

PRINCIPAL DISPLAY PANEL
CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29300-133
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE 2910 (5 MPA.S) 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
POLYETHYLENE GLYCOL 400 
POVIDONE, UNSPECIFIED 
STARCH, CORN 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITEScoreno score
ShapeRECTANGLE (Rounded-off) Size7mm
FlavorImprint CodeU;133
Contains    
Packaging
#Item CodePackage Description
1NDC:29300-133-1330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
2NDC:29300-133-4545 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
3NDC:29300-133-7575 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
4NDC:29300-133-1990 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
5NDC:29300-133-01100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
6NDC:29300-133-05500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
7NDC:29300-133-9966500 TABLET, FILM COATED in 1 DRUM
8NDC:29300-133-00200000 TABLET, FILM COATED in 1 DRUM
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07868006/26/2009
CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29300-134
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE 2910 (5 MPA.S) 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
POLYETHYLENE GLYCOL 400 
POVIDONE, UNSPECIFIED 
STARCH, CORN 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITEScoreno score
ShapeRECTANGLE (Rounded Off) Size9mm
FlavorImprint CodeU;134
Contains    
Packaging
#Item CodePackage Description
1NDC:29300-134-1330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
2NDC:29300-134-4545 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
3NDC:29300-134-7575 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
4NDC:29300-134-1990 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
5NDC:29300-134-01100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
6NDC:29300-134-05500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
7NDC:29300-134-101000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
8NDC:29300-134-505000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
9NDC:29300-134-9935700 TABLET, FILM COATED in 1 DRUM
10NDC:29300-134-00100000 TABLET, FILM COATED in 1 DRUM
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07868006/26/2009
Labeler - Unichem Pharmaceuticals (USA), Inc. (181620514)

 
Unichem Pharmaceuticals (USA), Inc.

← See all cetirizine hydrochloride brands

Medically reviewed on May 10, 2018

Further information

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

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