McNeil Consumer Healthcare has announced plans to lower the daily recommended maximum dose of Tylenol from 8 pills (4,000 mg) to 6 pills (3,000 mg) in an attempt to decrease the likelihood of accidental acetominophen overdose.
“Acetominophen is safe when used as directed,” Edwin Kuffner, MD, vice president of Over-the-Counter (OTC) Medical Affairs and Clinical Research at McNeil said in a press release. “But when too much is taken, it can cause liver damage.”
Currently more than 600 OTC and prescription medications contain acetaminophen — including Sudafed, NyQuill, Excedrin, Anacin, Midol, Theraflu, Alka-Seltzer, Percocet and Vicodin. As a result, many consumers may not realize that they can exceed the daily, recommended dose when taking multiple products at the same time.
The dosing changes will be reflected on the packaging of Regular Strength Tylenol and other adult acetominophen containing products in 2012, and for Extra Strength Tylenol this fall.
McNeil’s decision comes after years of debate at the federal level. An FDA advisory panel first recommended dropping the maximum daily dose below 4,000 mg two years ago, suggesting a single 675 mg adult dose, but the FDA did not follow the recommendation.
The advisory panel also suggested the agency place a black box warning on prescription medications that combine acetominophen with other drugs, like hydrocodone (Vicodin), oxycodone (Percocet) and codeine (Tylenol 3). The FDA followed this recommendation and limited the maximum amount of acetominophen to 325 mg in each capsule or tablet of combination pain medication. These changes will be phased in during the next three years.