The makers of Tylenol have announced they are recommending new, lower dosing instructions for its painkiller in an effort to reduce accidental overdoses from its active ingredient, acetaminophen. The announcement comes six months after the Food and Drug Administration (FDA) asked prescription manufacturers of acetaminophen to limit the amount of acetaminophen in their medicines to no more than 325 milligrams (mg) in each tablet or capsules, and to update their safety labels to include a black box warning for the risk of severe liver injury. Boxed warnings are the FDA’s strongest warning for prescription drugs and include situations where there is a significant risk for serious or even life-threatening reactions.
Over-the-counter products that contain acetaminophen include Tylenol and Midol and do not exceed the 325-milligram limit per tablet criteria the FDA is imposing. Extra strength Tylenol has 250 mg. Many prescription drugs that contain acetaminophen in the higher levels are combined with other ingredients, usually opioids such as codeine (Tylenol with Codeine), oxycodone (Percocet), and hydrocodone (Vicodin).
McNeil Consumer Healthcare, a division of Johnson & Johnson, says its new recommendations lower the maximum dosage for extra strength Tylenol to six pills – or a total of 3,000 mg a day, down from eight pills, or 4,000 mg, which is the current maximum daily dose.
The FDA says taking acetaminophen as prescribed is safe, but some people accidentally exceed the recommended dose when taking multiple products at the same time, often without realizing they contain acetaminophen or by not reading and following the dosing instructions.
The new labels will appear on extra strength Tylenol products this fall. The company says it also plans to lower the maximum daily dose on regular strength Tylenol and other adult products containing acetaminophen starting in 2012.