Drugplain

Cetirizine Hydrochloride Hives Relief 5 mg/1

Cetirizine · TABLET · Amneal Pharmaceuticals LLC

No Recall History
Plain English

Cetirizine Hydrochloride Hives Relief is a tablet containing cetirizine at 5 mg/1, taken oral. Manufactured by Amneal Pharmaceuticals LLC.

Key Facts

Brand Name
Cetirizine Hydrochloride Hives Relief
Generic Name
Cetirizine
NDC Code (Product)
65162-145
Manufacturer
Amneal Pharmaceuticals LLC
Strength
5 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
ANDA078780
Marketing Start
01/21/2010

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective12,920 reports
fatigue12,582 reports
pain11,990 reports
rash9,691 reports
off label use9,364 reports
abdominal discomfort9,349 reports
alopecia9,299 reports
rheumatoid arthritis8,785 reports
systemic lupus erythematosus8,568 reports
pemphigus8,386 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.

Dosage & Administration

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

Warnings

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.

Frequently Asked Questions

What is Cetirizine Hydrochloride Hives Relief used for?

Cetirizine Hydrochloride Hives Relief contains Cetirizine. It is a tablet taken oral. Consult your doctor for specific uses.

Is Cetirizine Hydrochloride Hives Relief a controlled substance?

Cetirizine Hydrochloride Hives Relief is not classified as a controlled substance by the DEA.

What is the generic name for Cetirizine Hydrochloride Hives Relief?

The generic name for Cetirizine Hydrochloride Hives Relief is Cetirizine. There are 12 other brand versions of Cetirizine.

What is the NDC code for Cetirizine Hydrochloride Hives Relief 5 mg/1?

The NDC (National Drug Code) for Cetirizine Hydrochloride Hives Relief 5 mg/1 is 65162-145, listed by Amneal Pharmaceuticals LLC.