Package insert

A package insert is a document included in the package of a medication that provides information about that drug and its use. For prescription medications, the insert is technical, and provides information for medical professionals about how to prescribe the drug. Package inserts for prescription drugs often include a separate document called a 'patient package insert' with information written in plain language intended for the end-user -- the person who will take the drug or give the drug to another person, for example a minor. Inserts for over-the-counter medications are also written plainly. A package insert is a document included in the package of a medication that provides information about that drug and its use. For prescription medications, the insert is technical, and provides information for medical professionals about how to prescribe the drug. Package inserts for prescription drugs often include a separate document called a 'patient package insert' with information written in plain language intended for the end-user -- the person who will take the drug or give the drug to another person, for example a minor. Inserts for over-the-counter medications are also written plainly. In the US the document is called 'prescribing information' or the 'package insert' (PI) and layperson's document is called the patient package insert (PPI). In Europe the technical document is called the 'summary of product characteristics' and the document for end-users is called the 'patient information leaflet' (PIL) or 'package leaflet'.