Maximum Dose for Tylenol Lowered

McNeil Consumer Healthcare Division of McNeil-PPC, Inc. has 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 8 pills per day (4000 mg) to 6 pills per day (3000 mg). The change is designed to help encourage appropriate acetaminophen use and reduce the risk of accidental overdose.

Acetaminophen can be found in more than 600 over-the-counter (OTC) and prescription medications, including Tylenol, Sudafed Triple Action, NyQuil, Percocet, and Vicodin. Acetaminophen is used by more than 50 million Americans each week to treat conditions such as pain, fever, and aches and pains associated with cold and flu symptoms.

“Acetaminophen is safe when used as directed,” said Edwin Kuffner, MD, vice president of OTC Medical Affairs and Clinical Research at McNeil Consumer Healthcare, in a statement. When too much is taken, however, “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 is revising its labels for products containing acetaminophen in an attempt to decrease the likelihood of accidental overdosing in those instances.”

McNeil has informed the FDA that the new dosing instructions will appear on Extra Strength Tylenol product packages in the United States beginning in the fall of 2011. McNeil will also be lowering the maximum daily dose for Regular Strength Tylenol and other adult acetaminophen-containing products starting in 2012. Consumers can continue to use Tylenol and other adult acetaminophen-containing products as currently labeled. The company is working with other manufacturers of acetaminophen products to help ensure consistency in dosing instructions.

In addition to the new dosing instructions on the OTC label, the makers of Tylenol 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, Tylenol’s Web site 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—a message printed directly on bottle caps to remind consumers to always read and follow the label instructions—on select Extra Strength Tylenol products. The messaging is scheduled to appear on select Extra Strength Tylenol caps starting in 2012.