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A package insert from 1970, with Ovrette brand contraception pills A package insert is a document included in the package of a medication that provides information about that drug and its use. For prescription medications , the insert is technical , providing information for medical professionals about how to prescribe the drug.
The documents published use the HL7 version 3 Structured Product Labeling (SPL) standard, [1] which is an XML format that combines the human readable text of the product label with structured data elements that describe the composition, form, packaging, and other properties of the drug products in detail according to the HL7 Reference ...
In the United States, a boxed warning (sometimes "black box warning", colloquially) is a type of warning that appears near the beginning of the package insert for certain prescription drugs, so called because the U.S. Food and Drug Administration specifies that it is formatted with a 'box' or border around the text [1] to emphasize its ...
Structured Product Labeling (SPL) is a Health Level Seven International (HL7) standard which defines the content of human prescription drug labeling in an XML format. [1] The "drug labeling" includes all published material accompanying a drug, such as the Prescribing Information which contains a great deal of detailed information about the drug.
The Open Packaging Conventions (OPC), for the package model and physical package, is defined and used by various document types in various applications from multiple vendors. It defines core properties, thumbnails, digital signatures, and authorizations & encryption capabilities for parts or all of the contents in the package.
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The results of the testing program are codified in an FDA-approved public document that is called the product label, package insert or Full Prescribing Information. [10] The prescribing information is widely available on the web from the FDA, [11] drug manufacturers, and frequently inserted into drug packages. The main purpose of a drug label ...
Indiana may not have been one of the very best teams in college football, but a team that goes 11-1 in a power conference was always going to be a foregone conclusion to make the 12-team College ...