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For prescription medications, the insert is technical, providing 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 ...
Drug labelling is also referred to as prescription labelling, is a written, printed or graphic matter upon any drugs or any of its container, or accompanying such a drug. Drug labels seek to identify drug contents and to state specific instructions or warnings for administration, storage and disposal.
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 ...
An auxiliary label (also called cautionary and advisory label or prescription drug warning label) is a label added on to a dispensed medication package by a pharmacist in addition to the usual prescription label. These labels are intended to provide supplementary information regarding the safe administration, use, and storage of the medication. [1]
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The Physicians' Desk Reference (PDR), renamed Prescriber's Digital Reference after its physical publication was discontinued, is a compilation of manufacturers' prescribing information (package insert) on prescription drugs, updated regularly and published by ConnectiveRx.
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A registrant or private label distributor with a given labeler code must use only one Product-Package Code configuration (e.g., a 3-digit product code combined with a 2-digit package code or a 4-digit product code combined with a 1-digit package code). [3] The official FDA format for NDCs separates the 3 segments with dashes.