Definition: 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.
Other names Product Labeling, Drug; Package Inserts, Drug; Labeling, Drug; Package Insert, Drug; Labelling, Drug; Labeling, Drug Product; Inserts, Drug Package; Insert, Drug Package; Drug Product Labeling; Drug Package Inserts; Drug Package Insert; Drug Labelling
