Definitions for "PACKAGE INSERT"
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.
Any promotional piece included in a mailed offer. It may be for different products from the same company, or for products and services from other companies.
Refers to the prescribing information supplied with a marketed pharmaceutical product and summarizes known information about dosing, safety, and indication.
Promotional enclosure in outgoing product shipments.
Information about the test and/or instructions that come inside the box or package.
The written pamphlet in every diagnostic test kit which includes instructions for proper use (kit directions) of the kit. In addition, the package insert contains some or all of the following: information on intended use; summary and explanation of the test; principles of the procedure; reagents provided; special precautions; specimen collection, storage and transport; materials provided/not provided with kit; procedural limitations; performance characteristics; results; and quality control.