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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]
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 ...
Drug labelling, 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.
Warning label on a cigarette pack: "Smoking kills". Warning label for a personal watercraft. Warning label for toxic chemicals. A warning label is a label attached to a product, or contained in a product's instruction manual, warning the user about risks associated with its use, and may include restrictions by the manufacturer or seller on certain uses.
Warnings - covers possible serious side effects that may occur (e.g., boxed warning) Precautions - explains how to use the medication safely including physical impairments, food ( grapefruits ) and drug interactions; for example "Do not drink alcohol while taking this medication" or "Do not take this medication if you are currently taking MAOI ...
Reversing a lower court ruling, the 5th U.S. Circuit Court of Appeals in New Orleans found that the 11 warnings required under a 2020 Food and Drug Administration rule were "factual and ...
If a Schedule H drug also comes under the purview of Narcotic Drugs and Psychotropic Substances Act, 1985, the drug's label must prominently display the symbol "NRx" and a red-boxed warning "Schedule H drug. Warning : "Not to be sold by Retail without the prescription of a Registered Medical Practitioner".
Alcoholic drinks are a leading cause of cancer and should carry a warning about that risk on their labels, the U.S. surgeon general said Friday. Alcohol is a factor in nearly 100,000 newly ...
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