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Cetirizine Hydrochloride by Taro Pharmaceuticals U.S.A., Inc.

Dosage form: tablet
Ingredients: Cetirizine Hydrochloride 10mg
Labeler: Taro Pharmaceuticals U.S.A., Inc.
NDC Code: 51672-2097

Cetirizine Hydrochloride

Drug Facts

Active ingredient (in each tablet)

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. (1-800-222-1222)

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
  • do not use if carton is opened, or if imprinted inner safety seal on bottle is broken or missing
  • store between 20° to 25°C (68° to 77°F)
  • for lot number and expiry date see carton or bottle label.

Inactive ingredients

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

Questions?

Call 1-866-923-4914

Distributed by: Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Carton

Compare to the
active ingredient
in Zyrtec®*

NDC 51672-2097-1

Cetirizine
Hydrochloride
Tablets 10 mg
Antihistamine

ALLERGY

Indoor & Outdoor Allergies

24
Hour

Relief of:

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

100
Tablets
10 mg each

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51672-2097
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Cetirizine Hydrochloride (Cetirizine) Cetirizine Hydrochloride10 mg
Inactive Ingredients
Ingredient NameStrength
starch, corn 
hypromelloses 
lactose monohydrate 
magnesium stearate 
polyethylene glycols 
povidones 
titanium dioxide 
Product Characteristics
ColorWHITEScoreno score
ShapeROUND (biconvexed) Size8mm
FlavorImprint CodeCT;10
Contains    
Packaging
#Item CodePackage Description
1NDC:51672-2097-11 BOTTLE in 1 CARTON
1100 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07807207/22/2009
Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIOperations
Taro Pharmaceuticals Industries Ltd.600072078MANUFACTURE(51672-2097)

Revised: 06/2013
 
Taro Pharmaceuticals U.S.A., 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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