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Label/Labeling/Product Labeling

Similar or Alternative Terms Meaning the Same Thing Also called prescribing information, product information, package insert, and the PI
Related Term(s) Package Insert

Definitions

"Brochures, booklets, mailing pieces, detailing pieces, file cards, bulletins, calendars, price lists, catalogs, house organs, letters, motion picture films, film strips, lantern slides, sound recordings, exhibits, literature, and reprints and similar pieces of printed, audio or visual matter descriptive of a drug and references published (for example, the Physician's Desk Reference) for use by medical practitioners, pharmacists, or nurses, containing drug information supplied by the manufacturer, packer, or distributor of the drug and which are disseminated by or on behalf of its manufacturer, packer, or distributor are hereby determined to be labeling as defined in section 201(m) of the FD&C Act."

Source: Federal Food, Drug, and Cosmetic Act (FDCA).

The Product Labeling includes the most complete information about a prescription drug. It includes technical information about the chemistry of the drug, its proper use overall and in specific types of patients, and details about possible side effects. It is written for healthcare providers. When FDA approves a drug for marketing, it also approves the prescribing Product Labeling.

Source: FFDA


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