Johnson & Johnson gets US. Food and Drug Administration approval to sell its allergy medicine Zyrtec (cetirizine HCl) to sell without a prescription.

The tablet, chewable tablet, and syrup formulations of Zyrtec 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 non-prescription Zyrtec products are also approved for the relief of itching due to hives in people 6 years of age and older, including adults.

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

The tablets and chewable tablets are approved for adults and children of 6 years and older while the syrup is approved for adults and children of 2 years of age and older.

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 may cause drowsiness in some people at recommended doses. Other common side effects include fatigue and dry mouth.

On November 9, 2007, the FDA announced that it had approved Zyrtec-D, a product which contains cetirizine HCl and pseudo ephedrine HCl, for non-prescription use. Sales of the Zyrtec-D are subject to restrictions in the Combat Methamphetamine Epidemic Act.

Zyrtec is marketed and distributed by McNeil Consumer Healthcare, based in Fort Washington, Pennsylvania.