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Cetirizine Hydrochloride by NuCare Pharmaceuticals, Inc.

Dosage form: tablet, film coated
Ingredients: CETIRIZINE HYDROCHLORIDE 10mg
Labeler: NuCare Pharmaceuticals, Inc.
NDC Code: 68071-1988

Cetrizine HCL Tablet 10 mg

Drug Facts

Active ingredient (in each tablet)

Cetirizine HCl 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
adults and children 6 years and overone 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 overask a doctor
children under 6 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor

Other information
  • store between 20° and 25°C (68° - 77°F)

Inactive ingredients

Lactose monohydrate, microcrystalline cellulose, starch (corn), magnesium stearate, hypromellose, polydextrose, polyethylene glycol and titanium dioxide.

Questions or comments?

call 1-800-706-5575, weekdays, 8:30am - 5:00pm Eastern Standard Time

Manufactured by:Manufactured for:
Apotex Inc.Apotex Corp.
Toronto, OntarioWeston, Florida
Canada M9L 1T933326

PRINCIPAL DISPLAY PANEL - 10 mg

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68071-1988(NDC:60505-2633)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE 
CELLULOSE, MICROCRYSTALLINE 
STARCH, CORN 
MAGNESIUM STEARATE 
HYPROMELLOSES 
POLYDEXTROSE 
POLYETHYLENE GLYCOL 3350 
TITANIUM DIOXIDE 
Product Characteristics
ColorwhiteScoreno score
ShapeRECTANGLE (pillow-shaped) Size9mm
FlavorImprint Code10MG;APO
Contains    
Packaging
#Item CodePackage Description
1NDC:68071-1988-110 TABLET, FILM COATED in 1 BOTTLE
2NDC:68071-1988-330 TABLET, FILM COATED in 1 BOTTLE
3NDC:68071-1988-77 TABLET, FILM COATED in 1 BOTTLE
4NDC:68071-1988-990 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07831712/27/2007
Labeler - NuCare Pharmaceuticals, Inc. (010632300)
Establishment
NameAddressID/FEIOperations
NuCare Pharmaceuticals, Inc.010632300repack(68071-1988)

Revised: 02/2017
 
NuCare Pharmaceuticals, 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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