US FDA clears J&J's non-Rx Zyrtec

The US Food and Drug Administration has approved Zyrtec-D (cetirizine HCl 5mg and pseudoephedrine HCl 120mg), an allergy drug, for non-prescription use in adults and children 12 years of age and older. This drug combines an antihistamine with a nasal decongestant. The drug will be distributed by Johnson & Johnson's McNeil Consumer Healthcare unit.

Available as a prescription medicine since 2001, Zyrtec-D is now approved as a non-prescription drug for the relief 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. Zyrtec-D is also for reducing swelling of nasal passages, for relief of sinus congestion and pressure, and for restoring freer breathing through the nose.

The product, because it contains pseudoephedrine, is subject to the Combat Methamphetamine Epidemic Act, which means it will be sold "behind-the-counter," and retail establishments will be required to keep records of purchases.