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FDA Approves the Allergy Treatment Zyrtec(R) for Use Without a Prescription
Date:11/16/2007

- ZYRTEC(R) and ZYRTEC-D(R) 12 HOUR(R) to be Available in Stores Nationwide

January 2008 -

FT. WASHINGTON, Pa., Nov. 16 /PRNewswire/ -- McNeil Consumer Healthcare, a division of McNEIL-PPC, Inc., announced today that it received approval from the U.S. Food and Drug Administration (FDA) for the allergy treatment ZYRTEC(R) (cetirizine HCl) to be used without a prescription for adults and children. ZYRTEC(R) relieves symptoms due to perennial and seasonal allergic rhinitis, commonly referred to as indoor and outdoor upper respiratory allergies. ZYRTEC(R) also relieves itching due to hives.

The ZYRTEC(R) approval comes one week after the FDA granted the company approval to market ZYRTEC-D(R) 12 HOUR(R) (cetirizine HCl 5 mg/pseudoephedrine HCl 120 mg), which combines ZYRTEC(R) with a decongestant. ZYRTEC-D(R) and ZYRTEC(R), the number one prescribed allergy medication in the U.S.*, will be available in stores nationwide** in late January 2008 without a prescription in its original-prescription strength.

"For a decade, ZYRTEC(R), as a prescription medication, has been alleviating people's symptoms from perennial and seasonal allergies," said Ashley McEvoy, President, McNeil Consumer Healthcare. "By providing ZYRTEC(R) over-the-counter, we're offering allergy sufferers greater access to a convenient, effective and affordable treatment option that helps alleviate their specific allergy symptoms. In fact, for many allergy sufferers, ZYRTEC(R) will cost up to one third less than prescription ZYRTEC(R)."

ZYRTEC(R) is a once-a-day medication for adults and children that relieves indoor and outdoor allergy symptoms of sneezing, runny nose, and watery eyes for 24 hours. ZYRTEC-D(R) 12 HOUR(R) provides the added benefit of relieving nasal congestion. The FDA approved ZYRTEC(R) in 5mg and 10mg tablets, 5mg and 10mg chewable tablets, and 1mg/mL syrup. ZYRTEC-D(R) 12 HOUR(R) is also approved as an extended release tablet. Z
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SOURCE McNeil Consumer Healthcare
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