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Cetirizine Hydrochloride (cetirizine hydrochloride 5 mg) Dailymed

  1. Human OTC
  2. Archived
  3. Sun Pharmaceutical Industries, Inc.

Generic: cetirizine hydrochloride

Cetirizine Hydrochloride tablet, chewable - (cetirizine hydrochloride 5 mg) image

  1. FDA Adverse Reactions

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Active Ingredient (in Each Chewable Tablet)


For 5 mg:Cetirizine hydrochloride 5 mg For 10 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
  • 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 preventhives 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 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

  • may be taken with or without water

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)
  • do not use if inner safety seal is open or torn
  • see top layer for lot number and expiration date

Inactive Ingredients


acesulfame potassium, colloidal silicon dioxide, compressible sugar, crospovidone, FD & C Blue No # 2 Aluminum Lake, FD & C Red No # 40 Aluminum Lake, guar gum, magnesium oxide light powder, magnesium stearate, mannitol, microcrystalline cellulose, pregelatinized starch, prosweet N & A flavor powder, talc, tutti frutti flavor

Questions?


Call toll free 1-800-818-4555 weekdays

Principal Display Panel


For 5 mg Hives Relief: Original Prescription Strength NDC 47335-343-16 Children's Cetirizine Hydrochloride Chewable Tablets 5 mg HIVES Relief Antihistamine 24 hour Relief of ITCHING Due to Hives Tutti-frutti Flavor 6 yrs. & older 100 CHEWABLE TABLETS SUN PHARMACEUTICAL INDUSTRIES LTD.

For 10 mg Hives Relief: Original Prescription Strength NDC 47335-344-16 Children's Cetirizine Hydrochloride Chewable Tablets 10 mg HIVES Relief Antihistamine Tutti-frutti Flavor 6 yrs. & older 100 CHEWABLE TABLETS SUN PHARMACEUTICAL INDUSTRIES LTD.

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."

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"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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