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cetirizine hydrochloride by Jubilant Cadista Pharmaceuticals Inc.

Medically reviewed on February 26, 2018

Dosage form: tablet, chewable
Ingredients: Cetirizine Hydrochloride 5mg
Labeler: Jubilant Cadista Pharmaceuticals Inc.
NDC Code: 59746-285

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:

  • runny nose

  • itchy, watery eyes

  • sneezing

  • 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 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 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:

  • store between 20º to 25º C (68º to 77º F)

  • Phenylketonurics: Contains 1.68 mg Phenylalanine (a component of Aspartame) per 5 mg

  • Phenylketonurics: Contains 3.36 mg Phenylalanine (a component of Aspartame) per 10 mg

  • do not use if carton is opened or if blister unit is broken.

  • see bottom panel for lot number and expiration date.

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

Cetirizine Hydrochloride Chewable Tabelets 5 mg Allergy

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 

Cetirizine Hydrochloride Chewable Tablets 10 mg Allergy

CETIRIZINE HYDROCHLORIDE  
cetirizine hydrochloride tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59746-285
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Cetirizine Hydrochloride (Cetirizine) Cetirizine Hydrochloride5 mg
Inactive Ingredients
Ingredient NameStrength
Acesulfame Potassium 
Aspartame 
Betadex 
Silicon Dioxide 
Croscarmellose Sodium 
.alpha.-tocopherol, Dl- 
Ethylcelluloses 
Fd&c Yellow No. 6 
Fumaric Acid 
Hypromelloses 
Magnesium Stearate 
Mannitol 
Maltodextrin 
Cellulose, Microcrystalline 
Talc 
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize8mm
FlavorORANGEImprint CodeC285
Contains    
Packaging
#Item CodePackage Description
1NDC:59746-285-323 BLISTER PACK (BLISTER PACK) in 1 CARTON
130 TABLET, CHEWABLE (TABLET) in 1 BLISTER PACK
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 AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Cetirizine Hydrochloride (Cetirizine) Cetirizine Hydrochloride10 mg
Inactive Ingredients
Ingredient NameStrength
Acesulfame Potassium 
Aspartame 
Betadex 
Silicon Dioxide 
Croscarmellose Sodium 
.alpha.-tocopherol, Dl- 
Ethylcelluloses 
Fd&c Yellow No. 6 
Fumaric Acid 
Hypromelloses 
Magnesium Stearate 
Mannitol 
Maltodextrin 
Cellulose, Microcrystalline 
Talc 
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize11mm
FlavorORANGEImprint CodeC286
Contains    
Packaging
#Item CodePackage Description
1NDC:59746-286-323 BLISTER PACK (BLISTER PACK) in 1 CARTON
110 TABLET, CHEWABLE (TABLET) in 1 BLISTER PACK
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/FEIOperations
Jubilant Generics Limited Roorkee650369221MANUFACTURE(59746-285, 59746-286)

 
Jubilant Cadista Pharmaceuticals 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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