J&J will lower the top daily dose for single-ingredient Extra Strength Tylenol in the U.S. to six pills a day, or 3,000 milligrams, from 8 pills a day, or 4,000 milligrams, the company's McNeil Consumer Healthcare unit said. The move will take effect later this year, with similar changes for other acetaminophen products in 2012, J&J said.
Advisers to the Food and Drug Administration called for restrictions two years ago to prevent fatal overdoses of acetaminophen, citing its use in scores of over-the-counter and prescription drugs. The compound is found in more than 600 medications and can also cause liver damage.
While acetaminophen is safe when used as directed, some people accidentally exceed the recommended dose when taking multiple products at the same time, said Edwin Kuffner, McNeil's vice president of over-the-counter medical affairs, in the statement. McNeil is revising its labels for products containing acetaminophen in an attempt to decrease the likelihood of accidental overdosing in those instances.
The company said it was working with fellow manufacturers to ensure consistency in dosing instructions for acetaminophen. Recommendations for J&J's Regular Strength Tylenol will be changed next year, it said.
Besides Tylenol, acetaminophen is the active ingredient in the prescription painkillers Percocet and Vicodin and in some nonprescription pain relievers, including NyQuil and some Sudafed products. It's found in thousands of medicines taken for headaches, fever, sore throats and chronic pain.
But people taking multiple medicines at once don't always realize how much acetaminophen they are ingesting, partly because prescription drug labels often list it under the abbreviation "APAP."
Two years ago, a panel of advisers to the Food and Drug Administration called for restrictions to prevent accidental fatal overdoses of acetaminophen.
Then in January, the FDA said it would cap the amount of acetaminophen in Vicodin, Percocet and other prescription pain killers at 325 milligrams per capsule, just under half the 700 milligram maximum of some products on the market then. The agency also said it was working with pharmacies and other medical groups to develop standard labeling for acetaminophen.
Excessive use of acetaminophen can cause liver damage. In the U.S., it's blamed for 200 fatal overdoses and 56,000 trips to the emergency room each year.
Johnson & Johnson has ordered two massive recalls of its drugs products this year. In June, McNeil recalled Tylenol Extra Strength over reports of a musty, moldy odor. On Wednesday, another recall was announced. Tylenol said the label changes were not related to the recalls.
The Associated Press contributed to this report.
Copyright 2011 The Associated Press.