A document, approved by the FDA and furnished by the manufacturer of a drug, for use when dispensing the drug (i.e., inserted into the package). The document indicates approved uses, contraindications, and potential side effects.

a document, approved by the FDA and furnished by the drug manufacturer for use when dispensing the drug. The document indicates the drug's approved uses, contraindications and potential side effects

A document, approved by the FDA and furnished by the manufacturer of a drug (inserted into the package), for use when dispensing the drug. The document indicates approved uses, contraindications, and potential side effects.

A paper form containing the indications, common side effects and other relevant information known about a drug that can be found on the inside of any prescription drug container provided by the pharmacist.

A package insert or patient package insert (PPI) (in Europe, Patient Information Leaflet) is a document provided along with a prescription medication to provide additional information about that drug.