Tylenol to revise dosing instructions for extra-strength product

FORT WASHINGTON, Pa. — McNeil Consumer Healthcare on Thursday announced plans for new dosing instructions, lowering the maximum daily dose for single-ingredient Extra Strength Tylenol (acetaminophen) products sold in the United States from eight pills per day (4,000 mg) to six pills per day (3,000 mg).

"Acetaminophen is safe when used as directed," McNeil Consumer VP OTC medical affairs and clinical research Edwin Kuffner said. "But, when too much is taken … it can cause liver damage. 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."

McNeil has informed the Food and Drug Administration that the new dosing instructions will appear on Extra Strength Tylenol product packages in the United States beginning in fall 2011.

McNeil also will be lowering the maximum daily dose for regular strength Tylenol and other adult acetaminophen-containing products beginning in 2012.

In addition to the new dosing instructions on the OTC label, McNeil recently launched Get Relief Responsibly, a national initiative designed to educate consumers about the appropriate use of prescription and OTC medications, particularly those containing acetaminophen, and the importance of reading and following medication labels. As a part of this initiative, the Tylenol website has been enhanced to include interactive tools to help consumers identify products that contain acetaminophen.  

McNeil also announced that it will be introducing bottle cap messaging on select Extra Strength Tylenol products. The bottle cap messaging is a message printed directly on bottle caps to remind consumers to always read and follow the label instructions. This messaging is planned to appear on select Extra Strength Tylenol caps starting in 2012.