The makers of Tylenol have announced plans to lower the maximum daily dosage in hopes to reduce the risk of Acetaminophen overdose.
McNeil Consumer Healthcare Division will alter the dosing instructions for Extra Strength Tylenol, effective this fall, from a maximum 8 pills per day, or 4,000 mg, to 6 pills per day, or 3,000 mg, allotted. They will also introduce a "bottle cap messaging" system along with lower dosing instruction for all products containing Acetaminophen beginning in 2012.
Acetaminophen, the active ingredient in Tylenol sold over-the-counter, is used by more than 50 million Americans weekly to treat symptoms of pain, fever and infections, according to a press release released by McNeil.
According to Edwin Kuffner, M.D., Vice President of OTC Medical Affairs and Clinical Research at McNeil Consumer Healthcare, Acetaminophen is safe when used as directed but too much Acetaminophen in the body can cause acute liver damage or even death in some cases.
"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," said Kuffner.
Extra Strength Tylenol will adopt the new dosing instructions later this year. All other Tylenol products will have lower daily maximum recommendations starting in 2012. The introduction in "bottle cap messaging" on tops of bottle caps of Extra Strength Tylenol, set to begin next year, will serve as reminders to read dosage instructions.
The company, a subdivision of Johnson & Johnson, is working closely with other manufacturers of acetaminophen products along with the U.S. Food and Drug Administration (FDA) in an effort to keep dosing instructions consistent and to raise awareness of the risks associated with Acetaminophen overdose, the major cause of liver failure in the U.S.
"McNeil is revising its labels for products containing acetaminophen in an attempt to decrease the likelihood of accidental overdosing in those instances," said Kuffner.
These changes come forth after recent changes have been made by the makers of Tylenol who launched a campaign earlier this year entitled, "Get Relief Responsibly." The latest branch of its website had interactive tools to increase awareness regarding Acetaminophen-containing products and the importance of following dosage instructions, according to the press release.
Until the changes to dosages take place beginning this fall in the extra strength formula, the makers of Tylenol suggest users to follow current instructions on the labels.