The manufacturer of Tylenol announced new, lower dosing instructions for the painkiller on Thursday in an effort to reduce accidental overdose from acetaminophen, the product’s active ingredient.
McNeil Consumer Healthcare, a division of Johnson & Johnson, is recommending the maximum dosage for extra strength Tylenol be lowered to six pills – or a total of 3,000 milligrams (mg) a day, down from eight pills or 4,000 mg which is the current maximum daily dose.
“Acetaminophen is safe when used as directed,” said Dr. Edwin Kuffner, vice president of OTC Medical Affairs and Clinical Research at McNeil Consumer Healthcare. “But, when too much is taken, it (overdosing) can cause liver damage.”
According to McNeil, acetaminophen is in more than 600 over-the-counter and prescription medications including common pain relievers and fever reducers like NyQuil, Sudafed and Percocet. The company hopes the new label revisions will help consumers use the drug appropriately.
“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,” Kuffner said. “McNeil is revising its labels for products containing acetaminophen in an attempt to decrease the likelihood of accidental overdosing in those instances.”
The new labels will appear on extra-strength Tylenol products starting in the fall. The company also plans to lower the maximum daily dose on regular strength Tylenol and other adult products containing acetaminophen starting in 2012. McNeil says it is working with other acetaminophen manufacturers to make sure its products have similar instructions.
In January, in an effort to reduce the risk of liver damage, the Food and Drug Administration asked companies that make prescription products with acetaminophen to limit the amount of the drug to 325 mg per pill and place a boxed warning on all packaging.
The FDA knew of McNeil’s plan and said the change falls within the draft plan for acetaminophen, said agency spokeswoman Sandy Walsh. “We have stated in many public forums that lowering the maximum daily dose of acetaminophen is a step that will facilitate the safest use of this important medicine.”
Acetaminophen is one of the most widely used painkillers in the country. McNeil says more than 50 million Americans use the drug on a weekly basis. According to the National Institutes of Health, symptoms of overdose include nausea, vomiting, extreme tiredness, sweating, loss of appetite, unusual bleeding or bruising, yellowing of the skin or eyes and stomach pain.