FDA approves nonprescription Zyrtec-D for ages 12 and up

ROCKVILLE, Md. The Food and Drug Administration on Friday approved Zyrtec-D (cetirizine HCl 5 mg and pseudoephedrine HCl 120 mg) for nonprescription use in adults and children 12 years of age and older.

“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,” stated Andrea Leonard-Segal, director, Division of Nonprescription Clinical Evaluation in the FDA’s Center for Drug Evaluation and Research. “This approval reflects FDA’s commitment to bringing prescription drugs to the over-the-counter market when they can be safely used without a prescription.

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.