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Cetirizine Tablets Chewable

Pronunciation

Generic Name: cetirizine hydrochloride
Dosage Form: tablet, chewable

Drug Facts

Active ingredient

(in each chewable tablet)

Cetirizine HCl 5 mg

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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 reactions 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

  • may be taken with or without water
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

Other information

  • Store between 20 to 25 C (68 to 77 F)

Inactive ingredients

acesulfame potassium, artificial flavors, benzyl alcohol, betadex, colloidal silicon dioxide, dl-alpha-tocopherol, ferric oxide red, ferric oxide yellow, lactose monohydrate, magnesium stearate, maltodextrin, microcrystalline cellulose, propylene glycol, talc and tutti frutti flavor

 

Questions? 1-800-525-8747

Manufactured in India by Sandoz Private Ltd.,

for Sandoz Inc., Princeton, NJ 08540

Rev.02/2008

Principal Display Panel

NDC 0781-5283-64

Children's

Cetirizine HCl Chewable Tablets

5 mg

antihistamine

Tutti Frutti Flavored

30 Tablets

Do not use if individual blister unit is open or torn

 

ALLERGY

Indoor & Outdoor Allergies

24 hour Relief of

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

6 yrs. and older 5 mg each

 

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet, chewable
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0781-5283
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE 5 mg
Inactive Ingredients
Ingredient Name Strength
ACESULFAME POTASSIUM  
BENZYL ALCOHOL  
BETADEX  
COLLOIDAL SILICON DIOXIDE  
ALPHA-TOCOPHEROL, DL-  
FERRIC OXIDE RED  
FERRIC OXIDE YELLOW  
LACTOSE MONOHYDRATE  
MAGNESIUM STEARATE  
MALTODEXTRIN  
CELLULOSE, MICROCRYSTALLINE  
PROPYLENE GLYCOL  
TALC  
Product Characteristics
Color YELLOW (peach, mottled) Score no score
Shape ROUND Size 7mm
Flavor Imprint Code SZ;104
Contains         
Packaging
# Item Code Package Description
1 NDC:0781-5283-64 30 TABLET, CHEWABLE (TABLET) in 1 BOX, UNIT-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078692 02/14/2008
Labeler - Sandoz Inc (110342024)
Revised: 09/2009
 
Sandoz Inc



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