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printed materials available in the legal pharmacologic description of a drug, subject to detailed regulatory specifications, including approved chemical and proprietary names, description and classification, clinical pharmacology, approved indications and usage, contraindications, warnings, precautions, adverse reactions, drug abuse and dependence information, overdosage discussion, dosage and administration, formulations, and appropriate references; in the U.S., such materials are negotiated between the drug's manufacturer(s) and the U.S. Food and Drug Administration.
See also: label (3).
See also: label (3).
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 trademark 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.
labelA description of a drug product or device provided by the manufacturer and approved by the regulatory authority of a particular country or jurisdiction, which includes indications for its use, who should use it, adverse events, instructions for use, and safety information.
package insertPharmacology A synopsis of key physicochemical, pharmacologic, clinical efficacy, and clinical safety properties of a prescription drug, bundled therewith, intended to be highly readable and helpful to clinicians looking for specific information–eg, indications for use; forms of administration, side effects, etc; it is more cynically described as a hard-to-handle and difficult-to-read package 'stuffer' printed in Lilliputian type on Bible paper. See Advertising.
pack·age in·sert(pak'ăj in'sĕrt)
A manufacturer's printed guideline for the use and dosing of a drug; includes the pharmacokinetics, dosage forms, and other relevant information about a drug.