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cetirizine hydrochloride by Unichem Pharmaceuticals (USA), Inc.

Dosage form: tablet
Ingredients: CETIRIZINE HYDROCHLORIDE 5mgCETIRIZINE HYDROCHLORIDE 10mg
Labeler: Unichem Pharmaceuticals (USA), Inc.
NDC Code: 29300-330

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 USP 10 mg

OTC - PURPOSE SECTION

Antihistamine

INDICATIONS AND USAGE

relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.

WARNINGS

Severe Allergy Warning

Get emergency help immediately if you have hives along with any of the following symptoms:

  • trouble swallowing
  • dizziness or loss of consciousness
  • swelling of tongue
  • swelling in or around mouth
  • trouble speaking
  • drooling
  • wheezing or problems breathing

These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later.

Not a Substitute for Epinephrine.

If your doctor has prescribed an epinephrine injector for "anaphylaxis" or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.

Do not use

▪ to prevent hives from any known cause such as:

  • foods
  • insect stings
  • medicines
  • latex or rubber gloves because this product will not stop hives from occuring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause.

▪ 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.
  • hives that are an unusual color, look bruised or blistered.
  • hives that do not itch.

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.
  • symptoms do not improve after 3 days of treatment
  • the hives have lasted more than 6 weeks.

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 20° to 25° C (68° to 77° F)

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 Hives Relief

Cetirizine Hydrochloride Tablets 10 mg-For Hives Relief

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29300-330
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:29300-330-131 BOTTLE, PLASTIC in 1 CARTON
130 TABLET in 1 BOTTLE, PLASTIC
2NDC:29300-330-451 BOTTLE, PLASTIC in 1 CARTON
245 TABLET in 1 BOTTLE, PLASTIC
3NDC:29300-330-751 BOTTLE, PLASTIC in 1 CARTON
375 TABLET in 1 BOTTLE, PLASTIC
4NDC:29300-330-191 BOTTLE, PLASTIC in 1 CARTON
490 TABLET in 1 BOTTLE, PLASTIC
5NDC:29300-330-011 BOTTLE, PLASTIC in 1 CARTON
5100 TABLET in 1 BOTTLE, PLASTIC
6NDC:29300-330-9966500 TABLET in 1 DRUM
7NDC:29300-330-00200000 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:29300-340
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:29300-340-131 BOTTLE, PLASTIC in 1 CARTON
130 TABLET in 1 BOTTLE, PLASTIC
2NDC:29300-340-451 BOTTLE, PLASTIC in 1 CARTON
245 TABLET in 1 BOTTLE, PLASTIC
3NDC:29300-340-751 BOTTLE, PLASTIC in 1 CARTON
375 TABLET in 1 BOTTLE, PLASTIC
4NDC:29300-340-191 BOTTLE, PLASTIC in 1 CARTON
490 TABLET in 1 BOTTLE, PLASTIC
5NDC:29300-340-011 BOTTLE, PLASTIC in 1 CARTON
5100 TABLET in 1 BOTTLE, PLASTIC
6NDC:29300-340-9935700 TABLET in 1 DRUM
7NDC:29300-340-00100000 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)

Revised: 05/2012
 
Unichem Pharmaceuticals (USA), Inc.

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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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