Package Insert

What is Package Insert?

Package Insert definition and meaning on Health terms:
The Package Insert (formerly prescribing information) in the United States (USPI), is a document included inside the external packaging of a prescription or over-the-counter medicine to provide information for patients. In Europe, the patient information in the pack is the Package Leaflet (PL) (formerly called the Patient Information Leaflet (PIL)). The document is subject to detailed regulatory specifications, including approved chemical and proprietary names, descriptions, and classifications; clinical pharmacology; approved indications and usages; contraindications; warnings; precautions; possible adverse reactions (side effects); drug abuse and dependence information; over-dosage discussion; dosage and administration instructions; formulations; and appropriate references.