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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
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 it is of ...
For prescription medications, the insert is technical, and provides information for medical professionals about how to prescribe the drug. Package inserts for prescription drugs often include a separate document called a "patient package insert" with information written in plain language intended for the end-user -- the person who will take the ...
Indications are included in the Indications and Usage section of the Prescribing Information. The primary role of this section of labeling is to enable health care practitioners to readily identify appropriate therapies for patients by clearly communicating the drug's approved indication(s).
Their work led to mandating the inclusion of patient package inserts with oral contraceptives to explain their possible side effects and risks to help facilitate informed consent. [ 211 ] [ 212 ] [ 213 ] Today's standard dose oral contraceptives contain an estrogen dose that is one third lower than the first marketed oral contraceptive and ...
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This page was last edited on 7 October 2017, at 23:21 (UTC).; Text is available under the Creative Commons Attribution-ShareAlike 4.0 License; additional terms may ...