Zyrtec-D (cetirizine HCl 5 mg and pseudoephedrine HCl 120 mg), an allergy drug, has been approved for nonprescription use in adults and children over the age of 12 by the U.S. Food and Drug Administration.
Previously approved by the FDA in 2001 as a prescription drug, Zyrtec-D is now available without a prescription. It is indicated for the relief of symptoms due to hay fever or other upper respiratory allergies like runny nose, sneezing, itchy andwatery eyes, itching of nose or throat and nasal congestion. It also reduces the swelling of nasal passages for the relief of sinus congestion and pressure.
National Institute of Allergy and Infectious Diseases estimates that 50 million Amaericans suffer from hay fever and allergies every year and is the sixth leading cause of chronic disease.
"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.
Sales of the drug fall under the Combat Methamphetamine Epidemic Act and quantities are restricted and require the retail establishment to keep records of people purchasing the drug.
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