Cetirizine or its salts

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 children aged 2 to 11 years, in package sizes containing greater than 119 mg of cetirizine base. [**Note: 8.5 mg of cetirizine base is approximately equivalent to 10 mg of cetirizine hydrochloride.**]

Approval Date: January 21, 2025

Schedule: III

Footnote: