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Generic: cetirizine hydrochloride is used for the treatment of Rhinitis, Allergic, Perennial Urticaria


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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.

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 bulered.

  • hives that do not itch.

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

. 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 buler 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.

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 mgAntihistamine  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 buler 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 mgAntihistamine 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 buler unit is broken or torn. 30 Chewable Tablets                                     Orange Chewables 10 mg each
Cetirizine Hydrochloride Chewable Tablets 10 mg Hives  Relief

DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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