Boxed warning- Product Labeling

This term refers to a specially formatted warning that is the strongest level of safety warning that may be required by FDA for an approved medicine. Specifically, a boxed warning gives a brief explanation of any contraindications or serious warnings that may be associated with death or serious injury, with a cross-reference to more detailed information covered in the Warnings and/or
Contraindications sections of the PI. If a boxed warning is required, it will be found at the beginning of the PI, with the text surrounded by a thick black border, with the heading WARNING. For this reason, it is often referred to as a “black box” or “black box warning.”