Cetirizine Drug Facts

Dosage Form: tablet, chewable
Drug Facts

Active ingredient

(in each chewable 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 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	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

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 0781-5284-64

Children's

Cetirizine HCl Chewable Tablets

10 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 10 mg each

CETIRIZINE HYDROCHLORIDE  cetirizine hydrochloride  tablet, chewable

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0781-5284 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE 10 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 9mm Flavor Imprint Code SZ;106 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0781-5284-64 30 TABLET In 1 BOX, UNIT-DOSE None

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: 09/2009Sandoz Inc

More Cetirizine Drug Facts resources

• Cetirizine Drug Facts Side Effects (in more detail)
• Cetirizine Drug Facts Dosage
• Cetirizine Drug Facts Use in Pregnancy & Breastfeeding
• Drug Images
• Cetirizine Drug Facts Drug Interactions
• Cetirizine Drug Facts Support Group
• 73 Reviews for Cetirizine Drug Facts - Add your own review/rating

Compare Cetirizine Drug Facts with other medications

• Hay Fever
• Urticaria