Boxed warning
A TYPE OF WARNING THAT APPEARS ON THE PACKAGE INSERT FOR CERTAIN PRESCRIPTION DRUGS, SO CALLED BECAUSE THE U.S. FOOD AND DRUG ADMINISTRATION SPECIFIES THAT IT IS FORMATTED WITH A 'BOX' OR BORDER AROUND THE TEXT
Black-box warning; Black Box Warning; Black box warnings; Black Box Warnings; Black box warning; Black boxed warning
In the United States, a boxed warning (sometimes "black box warning", colloquially) is a type of warning that appears on the package insert for certain prescription drugs, so called because