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No Prescription Required for Zyrtec-D, FDA Says

Submitted by Daisy Sarma on Sat, 11/10/2007 - 10:20. ::

Zyrtec-D, a drug used to treat allergies, has been approved for non-prescription use in the US. Making the announcement through a statement released Friday, the U.S. Food and Drug Administration approved the use of the drug without prescriptions for patients aged 12 years and above.


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Zyrtec-D, whose chemical name is cetirizine hydrochloride/pseudoephedrine, is a combination of antihistamine and nasal decongestant. From 2001, the McNeil Consumer Healthcare has been marketing Zyrtec-D as a prescription drug.

The drug is prescribed for patients showing classic allergy symptoms, such as itchy nose and eyes, nasal congestion, and runny nose. Other conditions for which Zyrtec-D is prescribed include swollen nasal passages, pressure and congestion in the sinuses, and troubled breathing through the nose.

Allergies such as hay fever and others stand sixth in the list of chronic diseases in the United States. Studies conducted by the U.S. National Institute of Allergy and Infectious Diseases puts the number of Americans suffering from such allergies at 50 million annually, a huge number by any standards.

Zyrtec-D, though effective in curbing allergic reactions in the people that use them, has its own side effects, according to the FDA. The common side effects arising out of Zyrtec-D intake are dryness of the mouth and a feeling of drowsiness.

For this segment of people, making Zyrtec-D available without the prescription would be a big help. In the statement by the US FDA, the director of the Division of Nonprescription Clinical Evaluation, Dr. Andrea Leonard-Segal, said “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.”

However, even though Zyrtec-D would now be available without a prescription, there would still be certain limitations in place regarding the purchase and sale of the drug. The restrictions are in place mainly because of the pseudoephedrine content in Zyrtec-D.

Per the restrictions, there is a ceiling on the quantum of Zyrtec-D a person can buy at a time. Besides, stores stocking up on the drug need to keep track of the amount sold to different customers and all other relevant details. The restrictions are in place courtesy the Combat Methamphetamine Epidemic Act, a federal act passed in 2005.

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