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FDA Approves Over-The-Counter Zyrtec Allergy Drug November, 2007

The Food and Drug Administration said Friday it's approved Zyrtec-D, an allergy drug, as an over-the-counter product.

Zyrtec, made by a Johnson & Johnson unit, has been available as a prescription drug since 2001 for adults and children age 12 and older.

The drug combines an antihistamine, cetirizine, with a nasal decongestant, pseudoephedrine. The FDA said Zyrtec-D is approved for the relief of symptoms from hay fever or other upper respiratory allergies such as runny nose, sneezing, itchy, watery eyes, along with relief of nasal and sinus congestion.

Common side effects seen with Zyrtec-D include drowsiness, fatigue and dry mouth.

"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," said Andrea Leonard-Segal, the director of FDA's division of nonprescription clinical evaluation.

Because the product contains pseudoephedrine, the product will be sold from behind pharmacy- or retail-store counters. Consumers are required to show identification, sign a log book and are limited in the amount of pseudoephedrine-containing products they can purchase. In large amounts, pseudoephedrine can be used to make the illegal drug methamphetamine Hay fever and other allergies are the sixth leading cause of chronic disease, with about 50 million sufferers in the U.S., according to the National Institutes of Health.

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