Tylenol to Carry New Warning Label in October

The warning will say “CONTAINS ACETAMINOPHEN” and “ALWAYS READ THE LABEL,” alerting Tylenol users of the potentially fatal side effects of acetaminophen caused by liver damage.

According to Tylenol drug maker Johnson & Johnson, the warning will be on the top of every new bottle of Extra Strength Tylenol that is sold in the United States in October, and it will begin to appear on most other Tylenol bottles in the following months.

The warning will be an explicit message stating that Tylenol contains acetaminophen, the main pain relieving ingredient in Tylenol, which has become the leading cause of sudden liver failure in the United States.

The point of putting the warning on the top of the bottle in red letters is to make sure that those who don’t normally read warning labels aren’t able to miss it.

“We’re always looking for ways to better communicate information to patients and consumers,” said Edwin Kuffner, vice president of McNeil Consumer Healthcare, the Johnson & Johnson unit that makes Tylenol.

Every year 55,000 to 80,000 Tylenol users are sent to the emergency room due to overdosing on the popular pain reliever. And each year, at least 500 people die as a result of acetaminophen overdose, according to the Centers for Disease Control and Prevention and the U.S. Food and Drug Administration report.

The main ingredient, acetaminophen is used in over 600 other over-the-counter products including popular brands such as Nyquil cold medicine and Sudafed sinus medication.

There are 85 lawsuits against Tylenol drug maker Johnson & Johnson saying that the pain reliever is responsible for liver injuries and death. The Tylenol lawsuits were consolidated into multi-district litigation in April 2013 in the U.S. District Court in the Eastern District of Pennsylvania.

The Tylenol lawsuits charge Johnson & Johnson, Tylenol drug maker, with failing to adequately warn about the risk of liver damage or liver failure associated with the pain medication.
The FDA is also currently in the process of drafting new safety measures that could limit how much Tylenol and other acetaminophen products are used.

Most of the concern lies with the “extra-strength” versions of Tylenol due to the potency of the pills. Two Extra Strength Tylenol pills contain 1,000 milligrams of acetaminophen. By comparison, regular strength contains 650 milligrams. However, the extra strength version is so preferred by consumers that many drug stores don’t even carry the regular strength.

Johnson & Johnson says that the warning label does not mean that the popular pain reliever is no longer safe, but that consumers need to be wary of overuse.

“We remain confident in the efficacy of Tylenol products, which rightfully have been trusted by doctors, hospitals and consumers for more than 50 years,” McNeil said in a statement.

If you or someone you know has experienced Tylenol side effects like liver failure or liver damage, legal options are available to you. Learn more and get a free legal consultation regarding a claim’s eligibility at the Tylenol Liver Damage, Stevens Johnson Syndrome Lawsuit Investigation. Experienced legal professionals have access to medical experts to assess whether or not a Tylenol played a role in your liver damage or other serious side effects, so act now.