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Cetirizine Hydrochloride by Sun Pharmaceutical Industries, Inc.

Dosage form: tablet, chewable
Ingredients: CETIRIZINE HYDROCHLORIDE 5mg
Labeler: Sun Pharmaceutical Industries, Inc.
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

relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.

Warnings

Severe Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms:

  • trouble swallowing
  • dizziness or loss of consciousness
  • swelling of tongue
  • swelling in or around mouth
  • trouble speaking
  • drooling
  • wheezing or problems breathing

These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later.
 
Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrine injector for “anaphylaxis” or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.

Do not use
  • to prevent hives from any known cause such as:
    • foods
    • insect stings
    • medicines
    • latex or rubber gloves because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause.
  • 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.
  • hives that are an unusual color, look bruised or blistered
  • hives that do not itch

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.
  • symptoms do not improve after 3 days of treatment
  • the hives have lasted more than 6 weeks

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 Hives Relief:
Original Prescription Strength
NDC 47335-343-16
Children's
Cetirizine Hydrochloride Chewable Tablets
5 mg
HIVES Relief
Antihistamine
24 hour Relief of ITCHING Due to Hives
Tutti-frutti Flavor
6 yrs. & older
100 CHEWABLE TABLETS
SUN PHARMACEUTICAL INDUSTRIES LTD.







For 10 mg Hives Relief:
Original Prescription Strength
NDC 47335-344-16
Children's
Cetirizine Hydrochloride Chewable Tablets
10 mg
HIVES Relief
Antihistamine
Tutti-frutti Flavor
6 yrs. & older
100 CHEWABLE TABLETS
SUN PHARMACEUTICAL INDUSTRIES LTD.






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:47335-343-1530 TABLET, CHEWABLE in 1 BOTTLE
2NDC:47335-343-16100 TABLET, CHEWABLE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09014209/26/2011
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:47335-344-1530 TABLET, CHEWABLE in 1 BOTTLE
2NDC:47335-344-16100 TABLET, CHEWABLE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09014209/26/2011
Labeler - Sun Pharmaceutical Industries, Inc. (146974886)
Establishment
NameAddressID/FEIOperations
Sun Pharmaceutical Industries Limited725959238ANALYSIS(47335-343, 47335-344), MANUFACTURE(47335-343, 47335-344)

 
Sun Pharmaceutical Industries, Inc.

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Medically reviewed on Oct 26, 2018

Further information

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

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