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 under the age of 2 years. [**Note: 8.5 mg of cetirizine base is approximately equivalent to 10 mg of cetirizine hydrochloride.**]
Approval Date: January 21, 2025
Schedule: I
Footnote: NR