Tylenol dose lowered to prevent overdose risk

Johnson & Johnson has announced plans for new dosing instructions that lower the maximum daily dose for single-ingredient Extra Strength Tylenol (acetaminophen) products sold in the United States from 8 pills per day (4,000 mg) to 6 pills per day (3,000 mg).

The change is intended to help encourage appropriate acetaminophen use and reduce the risk of accidental overdose, announced the company’s McNeil Consumer Healthcare Division.

McNeil has informed FDA that beginning fall 2011, the new dosing instructions will appear on Extra Strength Tylenol product packages in the United States. Beginning in 2012, McNeil will also lower the maximum daily dose for Regular Strength Tylenol and other adult products containing acetaminophen.

McNeil also announced that it will introduce “bottle cap messaging” on certain Extra Strength Tylenol products. These messages, printed directly on bottle caps, will remind consumers that they must always read and follow the label instructions. These messages are scheduled to appear on select Extra Strength Tylenol caps starting in 2012. Consumers can continue to use their Tylenol and other adult acetaminophen-containing products as currently labeled.

The company is working closely with other manufacturers of acetaminophen products to help ensure consistency in dosing instructions. 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, oxycodone (Percocet), and hydrocodone (Vicodin). More than 50 million Americans use acetaminophen each week for pain relief.

“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 company press release. “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.”


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 (www.tylenol.com/getreliefresponsibly).

In 2009, an FDA advisory committee recommended putting a stronger warning about the risk of severe liver damage on the labels of all prescription products containing acetaminophen. Then, in January, FDA asked manufacturers of prescription drugs containing acetaminophen to limit the dosage of the drug and add a liver toxicity warning to product labels. Makers of prescription products that include acetaminophen, such as Percocet, Vicodin, and Tylenol with Codeine, were required to limit the amount of the drug to no more than 325 mg per tablet or capsule.

Bill Mader, RPh, lead consultant at Pharmacy Outcomes Specialists, in Lake Zurich, Ill., believes that the adjustment in the maximum daily dose of acetaminophen is probably long overdue.

“With so many OTC products now available to the consumer that contain acetaminophen, even the savviest consumer cannot know about all the maximum doses of all the ingredients, especially when acetaminophen is listed as ‘APAP’ on the label,” Mader told Drug Topics. “Add to the mix prescription pain relievers, and the amount of acetaminophen can escalate pretty rapidly.”

Chronic long-term use of acetaminophen creates the greatest potential for liver failure when a patient is consuming 4,000 mg or more of acetaminophen daily, said Mader. “Combine this with other medications - and/or alcohol - that have toxic effects on the liver, and that's where problems can develop,” he said.