WASHINGTON — Tylenol bottles will soon bear red warnings alerting users to the potentially fatal risks of taking too much of the popular pain reliever. The unusual step comes amid lawsuits and pressure from the government that could have widespread ramifications for a medicine taken by millions of people every day.
Johnson & Johnson said the warning will appear in coming months on the caps of Extra Strength Tylenol and most other Tylenol bottles. It will make it explicit the over-the-counter drug contains acetaminophen, a pain-relieving ingredient that is the nation’s leading cause of sudden liver failure.
The new cap is designed to grab the attention of people who don’t read warnings that already appear in the fine print on the label.
‘‘We’re always looking for ways to better communicate information to patients and consumers,’’ said Dr. Edwin Kuffner, vice president at McNeil Consumer Healthcare, the Johnson & Johnson unit that makes Tylenol.
Overdoses from acetaminophen send 55,000 to 80,000 people to the emergency room in the United States each year and kill at least 500, according the Centers for Disease Control and Prevention and the Food and Drug Administration.
Acetaminophen is found in more than 600 over-the-counter products used by nearly one in four American adults every week, including household brands like Nyquil cold formula, Excedrin pain tablets, and Sudafed sinus pills.
Tylenol is the first of these products to include such a warning label on the bottle cap.
The move comes at a critical time: The company faces more than 85 personal injury lawsuits in federal court that blame Tylenol for liver injuries and deaths. And the Food and Drug Administration is drafting measures that could curtail the use of acetaminophen products.
Johnson & Johnson does not report sales of Tylenol, but total sales of all over-the-counter medicines containing acetaminophen were more than $1.75 billion last year, according to Information Resources Inc., a retail data service.
Safety experts are most concerned about ‘‘extra-strength’’ versions of Tylenol and other pain relievers with acetaminophen. A typical two-pill dose of Extra Strength Tylenol contains 1,000 milligrams of acetaminophen, compared with 650 milligrams for regular strength.
Most experts agree that acetaminophen is safe when used as directed, which generally means taking less than 4,000 milligrams a day.
‘‘The argument goes that if you take acetaminophen correctly you will virtually never get into trouble,’’ said Dr. William Lee of the University of Texas Southwestern Medical Center. ‘‘But it’s the very fact that it’s easily accessible over the counter in bottles of 300 pills or more that puts people in harm’s way.’’
Lee said McNeil’s marketing has contributed to the ‘‘freewheeling’’ way that Americans take the drug. For decades, McNeil has advertised Tylenol as ‘‘the safest brand of pain reliever.’’
‘‘That has been their standard ploy in the past, and I would argue that safest it is not,’’ he said.
Kuffner stands by the safety claim: ‘‘When taken as directed, when people read and follow the label, I believe that Tylenol and the acetaminophen ingredient is one of the safest pain relievers on the market.’’