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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

Children'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:

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

  • swelling of tongue

  • trouble speaking

  • wheezing or problems breathing

  • dizziness or loss of conciousness

  • swelling in or around mouth

  • drooling

These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by 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 occuring. 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 transquillizers 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 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

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 & 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 59746-285-33 

Children's
Cetirizine Hydrochloride Chewable Tablets 5 mg
Antihistamine

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

HIVES Relief  
24 hour Relief of Itching due to hives 

6 yrs. & older 5 mg each
  

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

30 Chewable Tablets                                                                              Orange Chewables
5 mg each

Cetirizine Hydrochloride Chewable Tablets 5 mg Hives Relief

CADISTA                                                                       NDC 59746-286-33

Children's
Cetirizine Hydrochloride Chewable Tablets 10 mg
Antihistamine


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

HIVES Relief
24 hour Relief of Itching due to hives 

6 yrs. & older 10 mg each


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

30 Chewable Tablets                                     Orange Chewables
10 mg each

Cetirizine Hydrochloride Chewable Tablets 10 mg Hives  Relief

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:59746-285-333 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
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:59746-286-333 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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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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