The labeling approved by the Food and Drug Administration for a prescription drug product, which accompanies the product when shipped by the manufacturer to the pharmacist, but usually does not accompany the dispensed prescription. The package insert is directed at the prescribing professional, principally the physician, and states the appropriate uses of a drug, the mode of administration, dosage information, contraindications, and warnings. The legal effect of prescribing the drug in ways not described in the package insert is unclear.
An informational leaflet placed inside the container or package of prescription drugs. The U.S. Food and Drug Administration requires that the drug’s generic name, indications, contraindications, adverse effects, dosage, and route of administration be described in the leaflet.