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Cetirizine Hydrochloride by Sandoz Inc

Medically reviewed on June 4, 2018

Dosage form: tablet, chewable
Ingredients: CETIRIZINE HYDROCHLORIDE 5mg
Labeler: Sandoz Inc
NDC Code: 0781-5283

Drug Facts

Active ingredient

(in each chewable tablet)

Cetirizine HCl 5 mg

Purpose

Antihistamine

Keep Out of Reach of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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 20º to 25º C (68º to 77º 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.06/2014

Principal Display Panel

NDC 0781-5283-64

Children's

Cetirizine HCl Chewable Tablets

5 mg

antihistamine

TuttiFrutti 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:0781-5283
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
BENZYL ALCOHOL 
BETADEX 
SILICON DIOXIDE 
.ALPHA.-TOCOPHEROL ACETATE, DL- 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
PROPYLENE GLYCOL 
TALC 
Product Characteristics
ColorYELLOW (peach, mottled) Scoreno score
ShapeROUNDSize7mm
FlavorImprint CodeSZ;104
Contains    
Packaging
#Item CodePackage Description
1NDC:0781-5283-6430 BLISTER PACK in 1 CARTON
1NDC:0781-5283-061 TABLET, CHEWABLE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07869202/14/2008
Labeler - Sandoz Inc (110342024)

 
Sandoz Inc

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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