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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.
The Prescribing Information follows one of two formats: "physician labeling rule" format or "old" (non-PLR) format. For "old" format labeling a "product title" may be listed first and may include the proprietary name (if any), the nonproprietary name, dosage form(s), and other information about the product.
The SSRI medication sertraline is approved as an anti-depressant but is also commonly prescribed off-label to help men suffering from premature ejaculation. [16] Tramadol, an opioid painkiller, is used to treat premature ejaculation, [17] and may also be applied against restless legs syndrome. [citation needed]
Examples of auxiliary labels placed on prescriptions. 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.
Off-label use is the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, dosage, or route of administration. [1] Both prescription drugs and over-the-counter drugs (OTCs) can be used in off-label ways, although most studies of off-label use focus on prescription drugs.
Inverse benefit law – Drug benefit-harm ratio falls with marketing; List of abbreviations used in medical prescriptions; Medicines reconciliation; Medical device (such as hearing aids, for example) may be specified by a type of prescription; Off-label use – Use of pharmaceuticals for conditions different from that for which they were approved
Boxed warnings on drugs have received increased media attention in the United States since 2004. Among some of the more widely covered stories: In October 2004, the FDA began requiring that boxed warnings be placed on all antidepressant medications, warning they may result in an increased risk of suicidal tendencies in children and adolescents.
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.
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