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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]
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 ...
August 2022) (Learn how and when to remove this message) 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 .
Beyond adverse effects from the herb itself, "adulteration, inappropriate formulation, or lack of understanding of plant and drug interactions have led to adverse reactions that are sometimes life threatening or lethal."
It is the strongest warning that the FDA requires, and signifies that medical studies indicate that the drug carries a significant risk of preventable, serious or even life-threatening adverse effects. [2] [3] Economists and physicians have thoroughly studied the effects of FDA boxed warnings on prescription patterns.
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Type A: augmented pharmacological effects, which are dose-dependent and predictable [5]; Type A reactions, which constitute approximately 80% of adverse drug reactions, are usually a consequence of the drug's primary pharmacological effect (e.g., bleeding when using the anticoagulant warfarin) or a low therapeutic index of the drug (e.g., nausea from digoxin), and they are therefore predictable.
A synthetic food dye used in processed foods like confections, soft drinks, flavoring syrups, condiments and convenience foods in order to create a potent yellow or bright green coloring. Prevalence of allergenicity is unclear but it is the most likely azo dye to cause hypersensitivity and reactions may occur from ingestion or skin contact.