Cetirizine or its salts

when sold in concentrations of 8.5 mg or less of cetirizine base per unit dose, in products labelled for use in individuals 12 years of age and older. [**Note: 8.5 mg of cetirizine base is approximately equivalent to 10 mg of cetirizine hydrochloride.**]

Approval Date: January 21, 2025

Schedule: U

Footnote: