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On Thursday, the FDA proposed removing oral phenylephrine from the list of approved active ingredients for over-the-counter (OTC) nasal decongestants, citing concerns over its effectiveness. After ...
Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations) Search 16. OMUF OTC Monographs@FDA 17. Outsourcing Facility Product Report. 18. Postmarket Requirements and Commitments Search 19. PEPFAR President's Emergency Plan for AIDS Relief (PEPFAR) Database 20. Product-Specific Guidances for Generic Drug Development Database 21.
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.
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 ...
The OTC drug phenylephrine does not work to relieve congestion, an FDA advisory panel said Tuesday. The ingredient is found in a number of cold and allergy pills. FDA panel says common over-the ...
Oxymetazoline, sold under the brand name Afrin among others, is a topical decongestant and vasoconstrictor medication. It is available over-the-counter as a nasal spray to treat nasal congestion and nosebleeds, as eye drops to treat eye redness due to minor irritation, and (in the United States) as a prescription topical cream to treat persistent facial redness due to rosacea in adults.
The Food and Drug Administration (FDA) is proposing to remove from the market a common ingredient found in most oral over-the-counter cold medicines because it doesn’t work. The move brings FDA ...
Pseudoephedrine is widely available over-the-counter (OTC) in both single-drug and combination preparations. [30] [22] [13] [2] Availability of pseudoephedrine has been restricted starting in 2005 as it can be used to synthesize methamphetamine. [13] [2] Phenylephrine has replaced pseudoephedrine in many over-the-counter oral decongestant ...