CETIRIZINE HYDROCHLORIDE - cetirizine hydrochloride tablet, chewable 
Jubilant Cadista Pharmaceuticals Inc.

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Childrens's
Cetirizine Hydrochloride Chewable Tablets
Antihistamine

DRUG FACTS

Active Ingredient ( in each chewable tablet ) 

Cetirizine Hydrochloride 5 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 a 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 at (1-800-222-1222).

Directions:

may be taken with and without water

For Cetirizine hydrochloride chewable tablets 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 Cetirizine hydrochloride chewable tablets 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, artificial and natural flavors, aspartame, betadex, colloidal silicon dioxide, croscarmellose sodium, dl-alpha-tocopherol, ethyl cellulose, FD&C yellow # 6 aluminum lake, fumaric acid, hypromellose, magnesium stearate, mannitol, maltodextrin, microcrystalline cellulose and talc.

Questions? call 1-800-313-4623

Manufactured by:
Jubilant Generics Ltd.
Roorkee-247661, India

Marketed by:
Jubilant Cadista Pharmaceuticals Inc.
Salisbury, MD 21801, USA

Revised : November / 2014

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CADISTA                               NDC 59746-285-32

Children's
Cetirizine Hydrochloride Chewable Tablets 5 mg
Antihistamine 

ALLERGY

Phenylketonurics: contains 1.68 mg Phenylalanine (a component of Aspartame) per 5 mg tablets.

Indoor & Outdoor Allergies
24 hour Relief of
●  Sneezing 
●  Running Nose
●  Itchy,Watery Eyes
●  Itchy Throat or Nose

TAMPER EVIDENT : Do not use if blister unit is broken or torn.

6 yrs. & older
5 mg each


30 Chewable Tablets                  Orange Chewables
5 mg each

5mgcarton

CADISTA                               NDC 59746-286-32

Children's

Cetirizine Hydrochloride Chewable Tablets 10 mg
Antihistamine
 

ALLERGY

Phenylketonurics: contains 3.36 mg Phenylalanine ( a component of Aspartame) per 10 mg tablets.

Indoor & Outdoor Allergies
24 hour Relief of 
●  Sneezing 
●  Running Nose
●  Itchy,Watery Eyes
●  Itchy Throat or Nose

TAMPER EVIDENT : Do not use if blister unit is broken or torn.

6 yrs. & older
10 mg each


30 Chewable Tablets         Orange Chewables
10 mg each 

10mgcarton
CETIRIZINE HYDROCHLORIDE  
cetirizine hydrochloride tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59746-285
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)  
Aspartame (UNII: Z0H242BBR1)  
Betadex (UNII: JV039JZZ3A)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Croscarmellose Sodium (UNII: M28OL1HH48)  
.alpha.-tocopherol, Dl- (UNII: 7QWA1RIO01)  
Ethylcelluloses (UNII: 7Z8S9VYZ4B)  
Fd&c Yellow No. 6 (UNII: H77VEI93A8)  
Fumaric Acid (UNII: 88XHZ13131)  
Hypromelloses (UNII: 3NXW29V3WO)  
Magnesium Stearate (UNII: 70097M6I30)  
Mannitol (UNII: 3OWL53L36A)  
Maltodextrin (UNII: 7CVR7L4A2D)  
Cellulose, Microcrystalline (UNII: OP1R32D61U)  
Talc (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize8mm
FlavorORANGEImprint Code C285
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59746-285-323 in 1 CARTON02/19/2015
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09111602/19/2015
CETIRIZINE HYDROCHLORIDE  
cetirizine hydrochloride tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59746-286
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)  
Aspartame (UNII: Z0H242BBR1)  
Betadex (UNII: JV039JZZ3A)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Croscarmellose Sodium (UNII: M28OL1HH48)  
.alpha.-tocopherol, Dl- (UNII: 7QWA1RIO01)  
Ethylcelluloses (UNII: 7Z8S9VYZ4B)  
Fd&c Yellow No. 6 (UNII: H77VEI93A8)  
Fumaric Acid (UNII: 88XHZ13131)  
Hypromelloses (UNII: 3NXW29V3WO)  
Magnesium Stearate (UNII: 70097M6I30)  
Mannitol (UNII: 3OWL53L36A)  
Maltodextrin (UNII: 7CVR7L4A2D)  
Cellulose, Microcrystalline (UNII: OP1R32D61U)  
Talc (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize11mm
FlavorORANGEImprint Code C286
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59746-286-323 in 1 CARTON02/19/2015
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09111602/19/2015
Labeler - Jubilant Cadista Pharmaceuticals Inc. (022490515)
Registrant - Jubilant Generics Limited (650801538)
Establishment
NameAddressID/FEIBusiness Operations
Jubilant Generics Limited Roorkee650369221MANUFACTURE(59746-285, 59746-286)

Revised: 12/2019
Document Id: 1735144c-74fa-4815-ac46-7a6b1fc8b1eb
Set id: 3bbe5549-5678-a6ec-d854-2201cfe2bc76
Version: 3
Effective Time: 20191230
 
Jubilant Cadista Pharmaceuticals Inc.