McNeil Consumer Healthcare, a division of pharmaceutical company, Johnson & Johnson, announced this week that the company is reducing the maximum daily dose for its Extra Strength Tylenol product. The adjustment is being made in order to decrease the risk of accidental overdose from the drug’s active ingredient, acetaminophen. An overdose of acetaminophen is the top cause of liver failure, and beginning this fall, the label and packaging for Extra Strength Tylenol will now list the maximum daily dose as six pills or a total of 3,000 milligrams.
The changes to Extra Strength Tylenol, a product in short supply these days due to several recalls, will affect products sold in the United States. According to McNeil, acetaminophen is used in more than 600 over-the-counter and prescription medications, which includes commonly used pain relievers and fever reducers like NyQuil, Sudafed and Percocet. McNeil is hopeful that a reduction in the maximum daily dosage will ultimately help consumers use the drug safely. Starting in 2012, the company plans to also reduce the maximum daily dose for its Regular Strength Tylenol product, as well as other acetaminophen-containing pain relievers.
The changes implemented by J&J follow a recent request made by the FDA, in which the agency asked companies that manufacture products with acetaminophen to limit the amount used to 325mg per pill and place a boxed warning on all packaging. The FDA’s push for change was based on their efforts to reduce the risk of liver damage in patients taking the drug. Acetaminophen is one of the most widely used pain killers in the United States, with more than 50 million Americans taking the drug each week.