prescription drug labeling
- Guideline or reference source
- FDADST An FDA Guide to Drug Safety Terms
- Definition
- Drug labeling, commonly called the package insert or the prescribing information, provides information to the physician about what a prescription medication is supposed to do, who should and should not take it, and how to use it. Labeling also includes information on a drug's side effects and warnings, and information from the clinical trials of the drug. Some prescription drug labeling also includes a part that describes the prescribing information in words that consumers will understand.
- Related Term
- medication guide
- medicinal prescription
- prescription drug product
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