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FDA LABEL GENERIC: Cetirizine MFR: Jubilant Cadista Pharmaceuticals Inc.

Cetirizine Hcl 5 Mg Chewable Tablet

Table of Contents

 

Cetirizine Hydrochloride 5 mg

Cetirizine Hydrochloride 10 mg

Antihistamine

INDICATIONS AND USAGE

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

if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

you have liver or kidney disease. Your doctor should determine if you need a different dose.

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

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

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).

DOSAGE AND ADMINISTRATION

● 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.

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.

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

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