McNeil Announces New Dosing Instructions for Tylenol

Johnson & Johnson’s McNeil Consumer Healthcare Division is announcing new plans to lower the recommended dosing instructions for single-ingredient Extra-Strength Tylenol (acetaminophen) in an attempt to prevent accidental overdose and liver damage. The company also plans to reduce the maximum daily dose for Regular Strength Tylenol and other adult acetaminophen products in 2012.

Labels on the bottles will now list the maximum daily dose as six pills, or a total of 3,000 milligrams, down from eight pills a day or 4,000 milligrams. Acetaminophen is the active ingredient in Tylenol and numerous other prescription and nonprescription pain relievers, including Percocet, Vicodin, NyQuil and some Sudafed.

Two years ago, a panel of advisers to the Food and Drug Administration called for sweeping restrictions to prevent accidental fatal overdoses of acetaminophen, the most widely used painkiller in the country. Excessive use of acetaminophen can cause liver damage and is blamed for about 200 fatal overdoses every year in the U.S. Acetaminophen overdoses send 56,000 people to the emergency room annually.

“Acetaminophen is safe when used as directed,” Dr. Edwin Kuffner, McNeil’s head of over-the-counter medical affairs, said in a company news release. “McNeil is revising its labels for products containing acetaminophen in an attempt to decrease the likelihood of accidental overdosing.”

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