FDA News

FDA Approves Zyrtec for Nonprescription Use in Adults and Children

(Nov 26, 2007)-- The U.S. Food and Drug Administration has approved tablet, chewable tablet, and syrup formulations of Zyrtec (cetirizine HCl) for nonprescription use. The nonprescription drug is approved for the temporary relief of symptoms due to hay fever or other respiratory allergies (sneezing; runny nose; itchy, watery eyes; itchy throat or nose) in adults and children 2 years of age and older.

The nonprescription Zyrtec products also are approved for the relief of itching due to hives in people 6 years of age and older, including adults.

"The approval of Zyrtec for nonprescription use offers an additional treatment option for children and adults," said Andrea Leonard-Segal, M.D., director, Division of Nonprescription Clinical Evaluation in the FDA's Center for Drug Evaluation and Research. "As for all nonprescription drugs, consumers and caregivers should read and carefully follow all directions on the labeling."

The tablets and chewable tablets are approved for adults and children 6 years of age and older:

* for the treatment of the symptoms of hay fever and other respiratory allergies, and to relieve the itching due to hives.

The syrup is approved for:

* adults and children 2 years of age and older for the treatment of the symptoms of hay fever and other respiratory allergies, and adults and children 6 years of age and older to relieve the itching due to hives.

The company will market two distinct Zyrtec products for each dosage form. One will provide directions for treating the symptoms of hay fever and other respiratory allergies. The other will contain directions for use to relieve the itching due to hives.

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