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Cetirizine Hydrochloride by Sun Pharma Global FZE

Medically reviewed on July 31, 2017

Dosage form: tablet, chewable
Ingredients: CETIRIZINE HYDROCHLORIDE 5mg
Labeler: Sun Pharma Global FZE
NDC Code: 47335-343

Cetirizine Hydrochloride Chewable Tablets

Active ingredient (in each chewable tablet)

For 5 mg:
Cetirizine hydrochloride 5 mg

For 10 mg:
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 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
  • may be taken with or without water

For 5 mg:



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

For 10 mg:


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)
  • do not use if inner safety seal is open or torn
  • see top layer for lot number and expiration date

Inactive ingredients

acesulfame potassium, colloidal silicon dioxide, compressible sugar, crospovidone, FD & C Blue No # 2 Aluminum Lake, FD & C Red No # 40 Aluminum Lake, guar gum, magnesium oxide light powder, magnesium stearate, mannitol, microcrystalline cellulose, pregelatinized starch, prosweet N & A flavor powder, talc, tutti frutti flavor

Questions?

Call toll free 1-800-818-4555 weekdays

Principal Display Panel

For 5 mg Allergy:
Original Prescription Strength
NDC 47335-343-83
Children's
Cetirizine Hydrochloride Chewable Tablets
5 mg
ALLERGY
Antihistamine
Indoor & Outdoor Allergies
Tutti-frutti Flavor
6 yrs. & older
30 CHEWABLE TABLETS
SUN PHARMACEUTICAL INDUSTRIES LTD.






For 10 mg Allergy:
Original Prescription Strength
NDC 47335-344-83
Children's
Cetirizine Hydrochloride Chewable Tablets
10 mg
ALLERGY
Antihistamine
Indoor & Outdoor Allergies
Tutti-frutti Flavor
6 yrs. & older
30 CHEWABLE TABLETS
SUN PHARMA



CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47335-343
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
SILICON DIOXIDE 
SUCROSE 
CROSPOVIDONE 
FD&C BLUE NO. 2 
FD&C RED NO. 40 
GUAR GUM 
MAGNESIUM OXIDE 
MAGNESIUM STEARATE 
MANNITOL 
CELLULOSE, MICROCRYSTALLINE 
STARCH, CORN 
TALC 
Product Characteristics
ColorPURPLEScoreno score
ShapeROUNDSize8mm
FlavorTUTTI FRUTTIImprint Code343
Contains    
Packaging
#Item CodePackage Description
1NDC:47335-343-8330 TABLET, CHEWABLE in 1 BOTTLE
2NDC:47335-343-88100 TABLET, CHEWABLE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09014209/09/2011
CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47335-344
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
SILICON DIOXIDE 
SUCROSE 
CROSPOVIDONE 
FD&C BLUE NO. 2 
FD&C RED NO. 40 
GUAR GUM 
MAGNESIUM OXIDE 
MAGNESIUM STEARATE 
MANNITOL 
CELLULOSE, MICROCRYSTALLINE 
STARCH, CORN 
TALC 
Product Characteristics
ColorPURPLEScoreno score
ShapeROUNDSize10mm
FlavorTUTTI FRUTTIImprint Code344
Contains    
Packaging
#Item CodePackage Description
1NDC:47335-344-8330 TABLET, CHEWABLE in 1 BOTTLE
2NDC:47335-344-88100 TABLET, CHEWABLE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09014209/09/2011
Labeler - Sun Pharma Global FZE (864347344)
Establishment
NameAddressID/FEIOperations
Sun Pharmaceutical Industries Limited725959238ANALYSIS(47335-343, 47335-344), MANUFACTURE(47335-343, 47335-344)

 
Sun Pharma Global FZE

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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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