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Nonprescription Zyrtec-D for Allergies

Consumer Update

FDA has approved Zyrtec-D (cetirizine HCl 5 mg and pseudoephedrine HCl 120 mg), an allergy drug, for nonprescription use in adults and children 12 years of age and older. This drug combines an antihistamine with a nasal decongestant.

Available as a prescription drug since 2001, Zyrtec-D is now approved as a nonprescription drug for the relief of symptoms due to hay fever or other upper respiratory allergies such as, runny nose, sneezing, itchy, watery eyes, itching of the nose or throat, and nasal congestion. Zyrtec-D is also for reducing swelling of nasal passages, for relief of sinus congestion and pressure, and for restoring freer breathing through the nose. Zyrtec-D's common side effects include drowsiness, fatigue, and dry mouth.

Sales of the drug are subject to restrictions in the Combat Methamphetamine Epidemic Act. This law places restrictions on the sale of products containing pseudoephedrine, such as limiting the amount that an individual can purchase, and imposing record keeping requirements on the retail establishments that sell the product

Zyrtec-D is distributed by McNeil Consumer Healthcare, Fort Washington, Pa.

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

Updated: November 26, 2007

For more about food, medicine, cosmetic safety and other topics for your health, visit FDA.gov/ForConsumers.
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