Pharmaceutical Business review

FDA approves Zyrtec for nonprescription use

The nonprescription drug is approved for the temporary relief of symptoms due to hay fever or other respiratory allergies like sneezing, runny nose, itchy, watery eyes, in adults and children two years of age and older. The nonprescription Zyrtec products are approved for the relief of itching due to hives in people six years of age and older, including adults.

The syrup is approved for adults and children two years of age and older for the treatment of the symptoms of hay fever and other respiratory allergies, and adults and children six years of age and older to relieve the itching due to hives.

The FDA recently approved an over-the-counter version of Zyrtec, Zyrtec-D, which is not approved for the relief of 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. Zyrtec is marketed and distributed by McNeil Consumer Healthcare, a subsidiary of J&J.