package insert (P.I.)

package insert (P.I.), a leaflet that, by order of the U.S. Food and Drug Administration, must be placed inside the package of every prescription drug. The leaflet must include the brand name for the drug, its generic name, and its mechanism of action; state its indications, contraindications, warnings, precautions, adverse effects, and dosage forms; and include instructions for the recommended dose, time, and route of administration.