Johnson & Johnson's McNeil Consumer Healthcare announced the voluntary dosage reduction today. Labels will carry new dosing instructions this fall.
The company says it will cut the maximum dosage of Regular Strength Tylenol and other acetaminophen-containing products in 2012.
"Acetaminophen is safe when used as directed,” says Edwin Kuffner, MD, McNeil vice president of over-the-counter medical affairs. "But, when too much is taken, it can cause liver damage."
The action is intended to cut the risk of such accidental overdoses, the company says in a news release.
Current recommendations advise taking no more than 4,000 milligrams of acetaminophen a day. McNeil's new label will recommend taking no more than 3,000 milligrams of acetaminophen daily.
Each Extra Strength Tylenol pill is 500 milligrams; the regular strength formulation contains 325 milligrams per pill. Last January the FDA asked makers of prescription drugs to use no more than 325 milligrams of acetaminophen in any combination product. That request did not cover over-the-counter acetaminophen products.
A major cause of acetaminophen overdose is that people often don't realize a combination product contains the drug. They then take two or more acetaminophen-containing products at the same time, often exceeding the safe dosage.