Nov. 9, 2007 -- The FDA today announced its approval of nonprescription Zyrtec-D, an allergy drug for people aged 12 and older.
Zyrtec-D combines an antihistamine with a nasal decongestant.
Available as a prescription drug since 2001, Zyrtec-D is now approved as an over-the-counter drug for the relief of symptoms due to hay fever or other upper respiratory allergies such as runny nose; sneezing; itchy, watery eyes; itchy nose or throat; and nasal congestion.
Zyrtec-D is also approved to reduce swollen nasal passages, relieve sinus congestion and pressure, and restore freer breathing through the nose.
Hay fever and other allergies are the sixth leading cause of chronic disease, with about 50 million sufferers each year in the U.S., according to the National Institute of Allergy and Infectious Diseases.
"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," says Andrea Leonard-Segal, MD, in an FDA news release.
Leonard-Segal directs the Division of Nonprescription Clinical Evaluation in the FDA's Center for Drug Evaluation and Research.
Zyrtec-D's common side effects include drowsiness, fatigue, and dry mouth, according to the FDA.
Sales of the drug are subject to restrictions in the Combat Methamphetamine Epidemic Act, which restricts the sale of products containing the decongestant pseudoephedrine.
Those restrictions include limiting the amount of the drug that a person can purchase and imposing record-keeping requirements on retailers selling the product.
Over-the-counter Zyrtec-D is distributed by McNeil Consumer Healthcare.