Medication package insert
Medication Package Insert
A Medication Package Insert (pronounced: meh-di-kay-shun pak-ij in-sert) is a document included in the package of a prescription drug that provides information about that drug and its use. The document is required by law to be provided by the drug manufacturer and approved by the Food and Drug Administration (FDA).
Etymology
The term "Medication Package Insert" is derived from the practice of inserting the document into the drug's packaging. The term has been in use since the 20th century when regulations requiring such information to be provided with prescription drugs were first introduced.
Description
A Medication Package Insert typically includes information such as the drug's Generic Name, Brand Name, purpose, usage instructions, Dosage, potential side effects, contraindications, and information about clinical trials that have been conducted on the drug. It may also include information about the drug's Pharmacology, such as how it works in the body and how it is metabolized and excreted.
Related Terms
- Patient Information Leaflet: A document provided with prescription drugs in the European Union, similar to a Medication Package Insert.
- Prescribing Information: A more detailed document that provides information about a drug for healthcare professionals.
- Drug Label: The label on the drug's packaging that includes basic information about the drug.
See Also
External links
- Medical encyclopedia article on Medication package insert
- Wikipedia's article - Medication package insert
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