MONDAY, Nov. 12 (HealthDay News) -- The allergy drug Zyrtec-D has been approved for non-prescription use in adults and children aged 12 years and older, according to a statement by the U.S. Food and Drug Administration.
Zyrtec-D combines an antihistamine with a nasal decongestant (cetirizine HC1 5 mg and pseudoephedrine HC1 120 mg). It has been available as a prescription drug since 2001, and is intended for relief of symptoms of hay fever and other upper respiratory allergies, including sinus congestion, stuffy or runny nose, sneezing, itchy or watery eyes and itchy nose or throat, the FDA said.
Common side effects include drowsiness, fatigue and dry mouth, according to the FDA. Sales of the drug are subject to restrictions of the Combat Methamphetamine Epidemic Act, which places restrictions on products containing pseudoephedrine.
"The approval of this widely used drug for non-prescription use will enable many people to have access to another effective treatment for their allergy symptoms," said Andrea Leonard-Segal, M.D., director of the Division of Non-prescription Clinical Evaluation in the FDA's Center for Drug Evaluation and Research.
Zyrtec-D is distributed by McNeil Consumer Healthcare of Fort Washington, Pa.
More Information
