FRIDAY, Nov. 9, 2007 (HealthDay News) -- The U.S. Food and Drug Administration approved on Friday the allergy drug Zyrtec-D for non-prescription use in people 12 and older. It combines the antihistamine Zyrtec with a nasal decongestant.
Zyrtec-D (cetirizine hydrochloride/pseudoephedrine) has been sold as a prescription drug since 2001. Sold by McNeil Consumer Healthcare, it's prescribed for relief of allergy symptoms, including runny nose, sneezing, itchy eyes and nose, and nasal congestion.
Zyrtec-D also is used for reducing swelling of nasal passages, for relief of sinus congestion and pressure, and for restoring 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 United States, according to the U.S. 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," Dr. Andrea Leonard-Segal, director of the FDA's Division of Nonprescription Clinical Evaluation, said in a prepared statement.
Common side effects of Zyrtec-D include drowsiness and dry mouth, the FDA said.
Because the drug contains pseudoephedrine, it is subject to sales restrictions imposed by the federal Combat Methamphetamine Epidemic Act, passed in 2005. These restrictions include limiting the amount that a person can buy, and tracking requirements imposed on stores distributing the product, the FDA said.
More information
The FDA has more about this drug's history.
