Cetirizine Hydrochloride - Hives Tablet, Coated
FDA Label NDC 70010-293

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Granules Pharmaceuticals Inc. for the product Cetirizine Hydrochloride - Hives (NDC 70010-293). 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 cetirizine hydrochloride tablets, active ingredient ​(in each tablet), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Cetirizine Hydrochloride Tablets

Drug Facts

Active Ingredient ​(In Each Tablet)

Cetirizine HCl 10 mg

Purpose

Antihistamine

Uses

reduces hives and 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.

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 blistered

 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
  • in rare cases, you may experience itching after stopping cetirizine. Consult your healthcare provider if this happens.

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

adults and children 6 years and overone 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 overask a doctor
children under 6 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor

Other Information

◾store between 20° to 25°C (68° to 77°F)

◾Contains no ingredient made from a gluten-containing grain (wheat, barley or rye).

Inactive Ingredients

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

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