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


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cetirizine hydrochloride 10 mg oral tablet - x 36 round white

cetirizine hydrochloride 10 mg - x 36 round white

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Drug Facts

Active Ingredient (in Each Tablet)


For 5 mg: Cetirizine hydrochloride USP 5 mg For 10 mg: Cetirizine hydrochloride USP 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
  • dizziness or loss of consciousness
  • swelling of tongue
  • swelling in or around mouth
  • trouble speaking
  • drooling
  • wheezing or problems breathing

These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a 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 occurring. 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.

Ask A Doctor Before Use If 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

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.
  • 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.

Keep Out Of Reach Of Children.


In case of overdose, get medical help or contact a Poison Control Center right away. [1-800-222-1222]

Directions


For  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 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)
  • TAMPER EVIDENT: DO NOT USE IF SEAL OVER BOTTLE OPENING IS BROKEN OR MISSING.

Inactive Ingredients


colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

Questions?


call 1-855-274-4122 Keep the carton. It contains important information. Manufactured for: AUROHEALTH LLC 2572 Brunswick Pike Lawrenceville, NJ 08648 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 072, India M.L.No.: 19/HD/AP/95/F/R

Package Label-principal Display Panel - 5 Mg (30's Tablet Container Carton Label)


AUROHEALTH Original Prescription Strength                 NDC 58602-446-09 Cetirizine Hydrochloride Tablets USP 5 mg Antihistamine  HIVES Relief 24 hour                                          Relief of Itching                           Due to Hives                                 30 Tablets 5 mg each

Package Label-principal Display Panel - 5 Mg (10 X 10 Blister Carton Label)


AUROHEALTH NDC 58602-446-21 Original Prescription Strength  Cetirizine Hydrochloride Tablets USP 5 mg Antihistamine   HIVES Relief 24 hour Relief of Itching Due to Hives                           100 (10 x 10) Unit-dose Tablets

Package Label-principal Display Panel - 10 Mg (30's Tablet Container Carton Label)


AUROHEALTH Original Prescription Strength                  NDC 58602-447-09 Cetirizine Hydrochloride Tablets USP 10 mg Antihistamine 6 yrs & older HIVES Relief 24 hour Relief of itching                              Due to Hives 30 Tablets 10 mg each

Package Label-principal Display Panel - 10 Mg (10 X 10 Blister Carton Label)


AUROHEALTH NDC 58602-447-21 Original Prescription Strength Cetirizine Hydrochloride Tablets USP 10 mg Antihistamine 6 yrs & older                                 HIVES Relief 24 hour Relief of Itching Due to Hives               100 (10 x 10) Unit-dose Tablets

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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