Johnson & Johnson said it will add a red warning to caps of Tylenol to reinforce the risks of taking too much of the painkiller.
The alert will appear on the caps of Extra Strength Tylenol beginning in October, New Brunswick, New Jersey-based J&J said today in an e-mail. The message will reinforce existing warnings that the over-the-counter pill contains the ingredient acetaminophen, which has been linked to fatal liver failure. Tylenol bottles already alert consumers to the liver risk.
Acetaminophen overdose is the most-common cause of liver failure in the U.S. The ingredient is found in more than 600 medicines, including generic non-prescription pain relievers and stronger combination products that require a doctor’s order, such as Vicodin. The Food and Drug Administration is reviewing appropriate acetaminophen levels for over-the-counter products, Andrea Fischer, a spokeswoman for the agency, said in an e-mail.
The FDA cut the amount of acetaminophen that prescription products could contain to 325 milligrams per pill two years ago and said recently it would require warnings on prescription products with the ingredient about rare serious skin reactions.
Extra Strength Tylenol tablets contain 500 milligrams of the ingredient, according to the website for the product. The new warning on Tylenol caps, first reported by the Associated Press, will read: “Contains Acetaminophen” and “Always Read the Label.”
J&J is the world’s largest maker of health-care products. Its sales of over-the-counter drugs, including Tylenol, and nutritional products accounted for about 6.5 percent of the company’s $67 billion in sales last year.