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In October 2020, the U.S. Food and Drug Administration (FDA) required the drug label to be updated for all nonsteroidal anti-inflammatory medications to describe the risk of kidney problems in unborn babies that result in low amniotic fluid. [3] [4] They recommend avoiding NSAIDs in pregnant women at 20 weeks or later in pregnancy. [3] [4]
Naproxen, sold under the brand name Aleve among others, is a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain, menstrual cramps, and inflammatory diseases such as rheumatoid arthritis, gout and fever. [8] It is taken orally. [8] It is available in immediate and delayed release formulations. [8]
Naproxen/pseudoephedrine, sold under the brand name Aleve-D among others, is a fixed-dose combination medication used for the treatment of nasal congestion and other symptoms of the common cold. [1] It contains naproxen , as the sodium salt, a nonsteroidal anti-inflammatory drug (NSAID); and pseudoephedrine , as the hydrochloride, a nasal ...
DailyMed is a website operated by the U.S. National Library of Medicine (NLM) to publish up-to-date and accurate drug labels (also called a "package insert") to health care providers and the general public. The contents of DailyMed is provided and updated daily by the U.S. Food and Drug Administration (FDA). The FDA in turn collects this ...
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 ...
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.
Drug Facts labels include information on the product's active ingredient(s), indications and purpose, safety warnings, directions for use, and inactive ingredients. [ 18 ] The 2020 Coronavirus Aid, Relief, and Economic Security Act (CARES Act) includes reforms that modernize the way certain OTC drugs are regulated in the United States.
A drug label retrieved from a random clinic in Hong Kong. Over-prominence of the logo of clinics may be susceptible to the poor interpretation of drugs by patients. An effective drug label should demonstrate efficacy and safety. Imperfect drug label information or design may lead to misinterpretation and hence medication errors.