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: