Non-prescription Zyrtec-D For Allergies Approved By FDA

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Main Category: Allergy
Also Included In: Respiratory / Asthma;  Regulatory Affairs / Drug Approvals;  Immune System / Vaccines
Article Date: 10 Nov 2007 - 11:00 PDT

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The FDA (Food and Drug Administration, USA) has approved an allergy drug, Zyrtec-D (cetirizine HCl 5 mg and pseudoephedrine HCl 120 mg), for non-prescription use in children aged 12 and more and adults. In other words, Zyrtec-D is now an OTC (over-the-counter) drug.

Zyrtec-D has been on the market since 2001, but only as a prescription medication. The latest approval applies to OTC status for the relief of hay fever and other upper-respiratory allergies, such as sneezing, itchy/watery eyes, runny nose, itchy nose, itchy throat, and nasal congestion. Zyrtec-D is also indicated for nasal passage swelling, sinus congestion/pressure relief, and for restoring freer breathing through the nose.

About 50 million Americans suffer from hay fever and other allergies each year - these allergies are the sixth leading cause of chronic disease in the country (National Institute of Allergy and Infection Diseases).

Andrea Leonard-Segal, M.D., Director, Division of Nonprescription Clinical Evaluation, Center for Drug Evaluation and Research, FDA, said "The approval of this widely-used drug for nonprescription use will enable many people to have access to another effective treatment for their allergy symptoms. This approval reflects FDA's commitment to bringing prescription drugs to the over-the-counter market when they can be safely used without a prescription."

Side effects commonly associated with Zyrtec-D include, tiredness, dry mouth and drowsiness. The drug is subject to the Combat Methamphetamine Epidemic Act regarding its sales. This legislation limits the amount of pseudoephedrine an individual can purchase - retail establishments are required to keep a record of all pseudoephedrine-containing products sold.

Zyrtec-D is distributed by McNeil Consumer Healthcare, Fort Washington, Pa.

-- Allergies and Hay Fever Fact Sheet (FDA)
-- www.zyrtec.com

Written by׃ Christian Nordqvist
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