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The shellac coating is insoluble in stomach acid and may make the tablet difficult for the body to break down or assimilate. For this reason, it can also be used as an ingredient in time-released, sustained or delayed-action pills. The product is listed on the U.S. Food and Drug Administration's (FDA) inactive ingredient list. [7]
The Unique Ingredient Identifier (UNII) is an alphanumeric identifier linked to a substance's molecular structure or descriptive information and is generated by the Global Substance Registration System (GSRS) of the Food and Drug Administration (FDA).
Unique Ingredient Identifier; Proprietary database identifiers include those assigned by First Databank, Micromedex, MediSpan, Gold Standard Drug Database (published by Elsevier), and Cerner Multum MediSource Lexicon; these are cross-indexed by RxNorm, which also assigns a unique identifier (RxCUI) to every combination of active ingredient and ...
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The FDA's regulatory powers expanded in 1938 with the passage of the Food, Drug and Cosmetic Act, and a 1958 amendment divided food ingredients into two categories: additives that must be assessed ...
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 U.S. Food and Drug Administration (FDA) announced that it plans to ban products containing phenylephrine, an ingredient found in many over-the-counter (OTC) oral cold and flu medications.
An ingredient with a GRAS designation is exempted from the usual Federal Food, Drug, and Cosmetic Act (FFDCA) food additive tolerance requirements. [2] The concept of food additives being "generally recognized as safe" was first described in the Food Additives Amendment of 1958 , and all additives introduced after this time had to be evaluated ...