![]() ![]() Immediate-Release Guaifenesin Products Can Be Crushed Or SplitĪlthough the brand name Mucinex should not be crushed, generic Mucinex products (guaifenesin) are available in both immediate release and extended-release versions. Although they vary considerably in strength, both products last 12 hours. The regular strength tablets contain 600 mg of guaifenesin while the maximum strength contains 1,200 mg of guaifenesin. This could potentially cause side effects such as:īelow is a graphic showing both layers of the Mucinex tablet.īrand Mucinex is available in two strengths, regular and 'Maximum Strength'. Doing so will destroy the extended-release delivery system and cause the entire dose to be delivered all at once and not over 12 hours as intended. Since Mucinex tablets are considered "extended-release", they should not be cut, split, or crushed. This allows the product to be both quick acting and long-lasting. The first layer delivers a dose of the drug immediately after administration while the second layer releases over a time period of 12 hours. ![]() In fact, Mucinex tablets are formulated as a 'bi-layer delivery system'. Mucinex & Mucinex DM) are available only as ER (extended-release) formulations and last about 12 hours per dose. Why Brand Mucinex Cannot Be Crushed Or Splitīrand name Mucinex products (e.g. This could potentially cause an increase in side effects and will shorten the duration of action considerably. Receive notifications when there is new or updated information about a drug product shortage or a drug within selected therapeutic categories.Brand name Mucinex (guaifenesin) should not be crushed as the tablet is designed to be 'extended release', slowly releasing the active ingredient guaifenesin over a 12-hour period of time.Ĭrushing or cutting Mucinex will release the entire dose at once. If you have any questions, please contact: FDA Drug Shortages Mobile App Industry can notify the FDA Drug Shortage Staff of new discontinuances, GMP issues, increase in product demand, recalls, supply interruptions, or other events. This portal is intended ONLY for drug manufacturers/applicants. Industry can notify FDA Drug Shortage Staff via CDER Direct NextGen Portal. Woodcock discusses what the agency is doing to address the issue of drug shortages, and how the agency is working with industry to help lessen their impact.Īvailability of Antiviral Medications (PDF - 141 KB) For Industry: Send FDA Drug Shortage and Supply Notifications Director's Corner Podcasts: Drug Shortages.Search List of Extended Use Dates to Assist with Drug Shortages.2020) Report examines the underlying factors responsible for drug shortages and recommends enduring solutions Guidance | Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act.Report provides recommendations discussed at the 2018 meeting.Report | Drug Shortages: Root Causes and Potential Solutions.Webcast: November 2018 Drug Shortages Task Force Public Meeting.CDER’s Coronavirus Aid, Relief, and Economic Security Act (CARES Act) Drug Shortage Mitigation Efforts.Ninth Annual Report on Drug Shortages for Calendar Year 2021 (PDF - 462KB).We are working closely with the manufacturers on their efforts to further increase supply in response to the increased demand. FDA is continuing to closely monitor the pediatric ibuprofen and acetaminophen supplies which have experienced increased demand since the fall of 2022 due to increases in respiratory illnesses. FDA issues guidance to help increase supply of ibuprofen oral suspension products in hospitals and health systems Shortage notifications and updates may be reported to FDA at Shortages Database ![]() To report a drug shortage please contact the CDER Drug Shortage Staff at: occur for many reasons, including manufacturing and quality problems, delays, and discontinuations. Manufacturers provide FDA most drug shortage information, and the agency works closely with them to prevent or reduce the impact of shortages. For the latest information from the FDA on COVID-19 see our website at: Coronavirus Disease 2019 (COVID-19). The Drug Shortage Staff within the FDA’s Center for Drug Evaluation and Research (CDER) has asked manufacturers to evaluate their entire supply chain, including active pharmaceutical ingredients, finished dose forms, and any components that may be impacted in any area of the supply chain due to the COVID-19 outbreak. Coronavirus Disease (COVID-19): The FDA continues to take steps to monitor the supply chain.
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