Cetirizine Hydrochloride
FDA Label NDC 59746-285

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Jubilant Cadista Pharmaceuticals Inc. for the product Cetirizine Hydrochloride (NDC 59746-285). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient ( in each chewable tablet ), purpose, uses:, when using this product:, if pregnant or breast-feeding:, keep out of reach of children., directions:, inactive ingredients:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

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

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 20° to 25° C (68° to 77° 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

5mgcarton (Cetirizine5mgallergy)

5mgcarton (Cetirizine5mgallergy)

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 (Cetirizine10mgallergy)

10mgcarton (Cetirizine10mgallergy)

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