The United States Food and Drug Administration (FDA) has approved a drug which combines an antihistamine with a nasal decongestant, Zyrtec-D, for nonprescription use in adults and children 12 years of age and older. Zyrtec-D is made up of cetirizine hydrochloride, an antihistamine used in the treatment of allergies, hay fever, angioedema, and urticaria; and pseudoephedrine hydrochloride, nasal decongestant which is also used to produce the illegal and highly addictive stimulant methamphetamine.

"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, M.D., director, Division of Nonprescription Clinical Evaluation in the FDA's Center for Drug Evaluation and Research. "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."

Because the drug contains pseudoephedrine hydrochloride, due to the reason stated above, Zyrtec-D is subject to restrictions in the Combat Methamphetamine Epidemic Act, which means there is a limited amount an individual can purchase, and there are record keeping requirements on the retail establishments that sell the product.

The combination drug Zyrtec-D is available since 2001 on a prescription-only basis, for the treatment of symptoms due to hay fever or other upper respiratory allergies such as, runny nose, sneezing, itchy, watery eyes, itching of the nose or throat, and nasal congestion, the FDA said.

Zyrtec-D is distributed by Johnson & Johnson's McNeil Consumer Healthcare, Fort Washington, Pa. Johnson & Johnson acquired the drug in 2006 from Pfizer Inc. together with the entire Pfizer Consumer Healthcare business.