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


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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:


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 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 buler 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.

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 buler unit is broken or torn. 6 yrs. & older5 mg each 30 Chewable Tablets                  Orange Chewables 5 mg each

CADISTA                               NDC 59746-286-32 Children's Cetirizine Hydrochloride Chewable Tablets 10 mgAntihistamine  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 buler unit is broken or torn. 6 yrs. & older10 mg each 30 Chewable Tablets         Orange Chewables 10 mg each 

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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