McNeil Consumer Healthcare will reduce the maximum recommended dose of its painkiller Tylenol to reduce the risk of accidental overdose and liver damage caused by acetaminophen, according to a press release.
The dosage will be lowered from 8 pills per day (4,000 mg) to 6 pills per day (3,000 mg).
Currently, Acetaminophen, the active ingredient in Tylenol, is found in more than 600 over-the-counter (OTC) and prescription medications, such as TYLENOL, SUDAFED Triple Action, NyQuil, Percocet and Vicodin.
"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," he said.
The company told the FDA that the change in the dosing instructions will show on Extra Strength Tylenol product packages in the U.S. starting in the fall of 2011. The company also said it was working closely with its manufacturers to "ensure consistency in dosing instructions" for acetaminophen.
The major cause of liver failure in the United States is acetaminophen overdose, which results in thousands of hospitalizations annually.
In addition to lowering the dosage, McNeil Consumer Healthcare has also started a consumer campaign to educate consumers on the correct use of prescription and OTC medications and the importance of reading the medication labels.