CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet, chewable

cetirizine hydrochloride by

Drug Labeling and Warnings

cetirizine hydrochloride by is a Otc medication manufactured, distributed, or labeled by Jubilant Cadista Pharmaceuticals Inc., Jubilant Generics Limited, Jubilant Generics Limited Roorkee. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

CETIRIZINE HYDROCHLORIDE  
cetirizine hydrochloride tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59746-285
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Cetirizine Hydrochloride (UNII: 64O047KTOA) (Cetirizine - UNII:YO7261ME24)	Cetirizine Hydrochloride	5 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	ORANGE	Score	no score
Shape	ROUND	Size	8mm
Flavor	ORANGE	Imprint Code	C285
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59746-285-32	3 in 1 CARTON	02/19/2015
1		30 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA091116	02/19/2015

CETIRIZINE HYDROCHLORIDE  
cetirizine hydrochloride tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59746-286
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Cetirizine Hydrochloride (UNII: 64O047KTOA) (Cetirizine - UNII:YO7261ME24)	Cetirizine Hydrochloride	10 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	ORANGE	Score	no score
Shape	ROUND	Size	11mm
Flavor	ORANGE	Imprint Code	C286
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59746-286-32	3 in 1 CARTON	02/19/2015
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA091116	02/19/2015

Labeler - Jubilant Cadista Pharmaceuticals Inc. (022490515)

Registrant - Jubilant Generics Limited (650801538)

Establishment
Name	Address	ID/FEI	Business Operations
Jubilant Generics Limited Roorkee		650369221	MANUFACTURE(59746-285, 59746-286)