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cetirizine hydrochloride by Unichem Pharmaceuticals (USA), Inc.

Medically reviewed on May 21, 2018

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

Cetirizine Hydrochloride Tablets

DRUG FACTS

OTC - ACTIVE INGREDIENT SECTION

(IN EACH TABLET)

For 5 mg

Cetirizine HCl USP 5 mg

For 10 mg

Cetirizine HCl USP10 mg

OTC - PURPOSE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN

In case of overdose, get medical help or contact a Poison Control Center right away.

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 200 to 250C (680 to 770F)

INACTIVE INGREDIENT

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

OTC - QUESTIONS

call 1-866-562-4616

Manufactured by:

UNICHEM LABORATORIES LTD.

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

Distributed by:

Rochelle Park, NJ 07662.

PRINCIPAL DISPLAY PANEL

Cetirizine Hydrochloride Tablets 5 mg-For Allergy

Cetirizine Hydrochloride Tablets 10 mg-For Allergy

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet
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 K29/32 
STARCH, CORN 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITEScoreno score
ShapeRECTANGLE (Rounded-off) Size7mm
FlavorImprint CodeU;133
Contains    
Packaging
#Item CodePackage Description
1NDC:29300-133-131 BOTTLE in 1 CARTON
130 TABLET in 1 BOTTLE
2NDC:29300-133-451 BOTTLE in 1 CARTON
245 TABLET in 1 BOTTLE
3NDC:29300-133-751 BOTTLE in 1 CARTON
375 TABLET in 1 BOTTLE
4NDC:29300-133-191 BOTTLE in 1 CARTON
490 TABLET in 1 BOTTLE
5NDC:29300-133-011 BOTTLE in 1 CARTON
5100 TABLET in 1 BOTTLE
6NDC:29300-133-9966500 TABLET in 1 DRUM
7NDC:29300-133-00200000 TABLET in 1 DRUM
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07868011/30/2010
CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet
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 K29/32 
STARCH, CORN 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITEScoreno score
ShapeRECTANGLE (Rounded-off) Size9mm
FlavorImprint CodeU;134
Contains    
Packaging
#Item CodePackage Description
1NDC:29300-134-131 BOTTLE in 1 CARTON
130 TABLET in 1 BOTTLE
2NDC:29300-134-451 BOTTLE in 1 CARTON
245 TABLET in 1 BOTTLE
3NDC:29300-134-751 BOTTLE in 1 CARTON
375 TABLET in 1 BOTTLE
4NDC:29300-134-191 BOTTLE in 1 CARTON
490 TABLET in 1 BOTTLE
5NDC:29300-134-011 BOTTLE in 1 CARTON
5100 TABLET in 1 BOTTLE
6NDC:29300-134-9935700 TABLET in 1 DRUM
7NDC:29300-134-00100000 TABLET in 1 DRUM
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07868011/30/2010
Labeler - Unichem Pharmaceuticals (USA), Inc. (181620514)

 
Unichem Pharmaceuticals (USA), Inc.

← See all cetirizine hydrochloride brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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