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Home U.S. World Entertainment Sports Business Health Science Technology Politics Offbeat Environment Travel FDA limits acetaminophen levels in combo drugs Overdose from prescription combination products containing acetaminophen account for nearly half of all cases of acetaminophen-related liver failure in the U.S. Source: AHN Reporter: Ayinde O. Chase Location: Silver Springs, MD, United States Published: January 13, 2011 11:25 a.m. EST Topics: Politics, Regulatory Policy And Organization, Healthcare Policy, Health Treatment, Health The U.S. Food and Drug Administration is asking manufacturers of prescription products that contain acetaminophen to limit the amount of the pain reliever to no more than 325 milligrams in each tablet or capsule. The FDA also is requiring manufacturers to update labels of all prescription combination acetaminophen products to warn of the potential risk for severe liver injury. Acetaminophen is used in combination with other ingredients in numerous prescription drugs and is typically found in opioids such as codeine (Tylenol with Codeine), oxycodone (Percocet), and hydrocodone (Vicodin). "FDA is taking this action to make prescription combination pain medications containing acetaminophen safer for patients to use," said Dr. Sandra Kweder, the agency's deputy director of the Office of New Drugs. "Overdose from prescription combination products containing acetaminophen account for nearly half of all cases of acetaminophen-related liver failure in the United States; many of which result in liver transplant or death." Health officials stress that there is no immediate danger to patients who take these combination pain medications. The risk of liver injury primarily occurs when patients take multiple products containing acetaminophen at one time and exceed the current maximum dose of 4,000 milligrams within a 24-hour period. Acetaminophen also is widely used as an over-the-counter pain and fever medication, and is combined with other OTC ingredients, such as cough and cold ingredients. For more information and a list of affected products, visit the FDA's website at www.fda.gov/acetaminophen. Republish Email Facebook Digg Twitter Buzz Up! Share [ Close ] When publishing articles from AHN we require that you follow several simple rules and that you abide by our Terms and Conditions. You may: Use and display the provided article text on a website or blog. Under the following conditions: You may not republish the article(s) wholesale, automatically or systematically; articles must be republished individually. You may not sell license or redistribute the content without specific permission. Email us if you’d like to. You must display and attribute the article in the manner specified by AHN (but not in any way that suggests that we endorse you or your use of the work). 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