Use of written, printed, or graphic materials upon or accompanying a drug container or wrapper. It includes contents, indications, effects, dosages, routes, methods, frequency and duration of administration, warnings, hazards, contraindications, side effects, precautions, and other relevant information.

Synonyms: Labeling, Drug, Drug Labelling, Inserts, Drug Package, Warnings, Boxed, Boxed Warnings, Labelling, Drug, Warnings, Black Box, Package Insert, Drug, Warning, Black Box, Drug Labeling, Drug Product Labeling, Warning, Boxed, Drug Package Insert, Product Labeling, Drug, Package Inserts, Drug, Black Box Warnings, Box Warning, Black, Labeling, Drug Product, Drug Package Inserts, Boxed Warning, Insert, Drug Package, Black Box Warning, Box Warnings, Black