A<unk><unk>  from 1970, with Ovrette brand contraception pills A<unk><unk>  is a document included in the<unk>  of a<unk>  that provides information about that drug and its use. For prescription<unk> s, the<unk>  is technical, providing information for medical professionals about how to prescribe the drug.<unk><unk> s for prescription drugs often include a separate document called a "patient<unk><unk> " 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, such as a minor.<unk> s for over-the-counter<unk> s are also written plainly. In the United States, labelling for the healthcare practitioner is called "Prescribing Information" (PI), and labelling for patients and/or caregivers includes<unk>  Guides", "Patient<unk><unk> s", and "Instructions for Use". In Europe, the technical document is called the "summary of product characteristics" (SmPC), and the document for end-users is called the "patient information leaflet" (PIL) or<unk>  leaflet". Similar documents attached to the outside of a<unk>  are sometimes called outserts.
Medication package insert
Incident report
Drug labelling
Drug packaging
FDA warning letter
Drug coupon
Sentinel event
Procedure code