boxed warning (Q879952)

The strongest possible form of a warning FDA imposes. A type of warning on the package insert for certain prescription drugs, so called because the U.S. Food and Drug Administration requires a 'box' or border around the text.

black box warning

Language	Label	Description	Also known as
English	boxed warning	The strongest possible form of a warning FDA imposes. A type of warning on the package insert for certain prescription drugs, so called because the U.S. Food and Drug Administration requires a 'box' or border around the text.	black box warning