FORT WASHINGTON, Pa., July 28, 2011 /PRNewswire/ -- McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. ("McNeil") today announced plans for new dosing instructions lowering the maximum daily dose for single-ingredient Extra Strength TYLENOL® (acetaminophen) products sold in the U.S. from 8 pills per day (4,000 mg) to 6 pills per day (3,000 mg). The change is designed to help encourage appropriate acetaminophen use and reduce the risk of accidental overdose.
Acetaminophen, the active ingredient in TYLENOL®, can be found in more than 600 over-the-counter (OTC) and prescription medications, such as 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, M.D., Vice President of OTC Medical Affairs and Clinical Research at McNeil Consumer Healthcare. "But, when too much is taken (overdose), 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 U.S. Food and Drug Administration (FDA) that the new dosing instructions will appear on Extra Strength TYLENOL® product packages in the U.S. 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 beginning in 2012. Consumers can continue to use their TYLENOL® and other adult acetaminophen-containing products