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RIS () tablets for oral use Initial U.S. Approval: 2007 WARNING: POTENTIAL LIVER INJURY AND CONTRAINDICATION IN PREGNANCY See full prescribing information for complete boxed warning. Elevations of liver aminotransferases (ALT, AST) have been reported with and serious liver injury has been reported with related drugs. Monitor liver aminotransferases monthly and discontinue if 5 x ULN or if elevations are accompanied by bilirubin 2 x ULN or by sign.
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380A FAQ
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Drugs.com is the most popular, comprehensive and up-to-date source of drug information online. Providing free, peer-reviewed, accurate and independent data on more than 24,000 prescription drugs, over-the-counter medicines & natural products.
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Try the websites .drugs.com/fda-consumer/ or MedlinePlus. Drugs.com is designed for both consumers and health professionals.
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The Professional Drug Information database is a repository of drug information sourced directly from the FDA. It includes detailed notes on the clinical pharmacology of a wide variety of drugs.
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The following list is an outline of the requirements for a drug label: Highlights (a concise summary of label information) Full prescribing information. Limitations statement. Product names. Date of initial U.S. approval. Box warnings. Recent major changes. Indications and usage.
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FDA regulations require that all medication labels include: Name of Product. Table of Drug Facts. Active Ingredients. Proper Use and Purpose.
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What is the Prescribing Information? FDA-approved Prescribing Information (PI), also known as United States Prescribing Information (USPI), reflects FDA's finding regarding the safety and effectiveness of the human prescription drug under the labeled conditions of use.
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This must include easy identification of the active ingredient. Labels, whether produced by the manufacturer or applied by health professionals, must give patients enough information to use the medicine correctly and must be constructed in such a way as to provide easy access to this information.
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The Professional Drug Information database is a repository of drug information sourced directly from the FDA. It includes detailed notes on the clinical pharmacology of a wide variety of drugs.
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