CETIRIZINE HYDROCHLORIDE - cetirizine hydrochloride tablet, chewable 
Sun Pharmaceutical Industries, Inc.

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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:

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

  

Stop use and ask doctor if


an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding:

  

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

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


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.
spl-cetirizine-5mg-allergy-1
spl-cetirizine-5mg-allergy-2
spl-cetirizine-5mg-allergy-3
spl-cetirizine-5mg-allergy-4
spl-cetirizine-5mg-allergy-5

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
spl-cetirizine-10mg-allergy-1
spl-cetirizine-10mg-allergy-2
spl-cetirizine-10mg-allergy-3

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47335-343
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SUCROSE (UNII: C151H8M554)  
CROSPOVIDONE (UNII: 68401960MK)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GUAR GUM (UNII: E89I1637KE)  
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorPURPLEScoreno score
ShapeROUNDSize8mm
FlavorTUTTI FRUTTIImprint Code 343
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:47335-343-8330 in 1 BOTTLE; Type 0: Not a Combination Product09/09/2011
2NDC:47335-343-88100 in 1 BOTTLE; Type 0: Not a Combination Product09/09/2011
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 AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SUCROSE (UNII: C151H8M554)  
CROSPOVIDONE (UNII: 68401960MK)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GUAR GUM (UNII: E89I1637KE)  
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorPURPLEScoreno score
ShapeROUNDSize10mm
FlavorTUTTI FRUTTIImprint Code 344
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:47335-344-8330 in 1 BOTTLE; Type 0: Not a Combination Product09/09/2011
2NDC:47335-344-88100 in 1 BOTTLE; Type 0: Not a Combination Product09/09/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09014209/09/2011
Labeler - Sun Pharmaceutical Industries, Inc. (146974886)
Establishment
NameAddressID/FEIBusiness Operations
Sun Pharmaceutical Industries Limited725959238ANALYSIS(47335-343, 47335-344) , MANUFACTURE(47335-343, 47335-344)

Revised: 10/2018
Document Id: 06101976-e656-468e-89f3-d33ccbc1157c
Set id: a4758152-97dd-4a27-b4d9-11178654b93e
Version: 7
Effective Time: 20181026
 
Sun Pharmaceutical Industries, Inc.