Tylenol Gets New Acetaminophen Warning
August 30, 2013

Tylenol Packages Get New Acetaminophen Warnings

Brett Smith for redOrbit.com - Your Universe Online

As part of an effort to reduce liver damage due to the overuse of acetaminophen, Johnson & Johnson announced its Tylenol bottles will soon have a new warning label on their caps which reads: "Contains acetaminophen. Always read the label."

The primary active ingredient in Tylenol, acetaminophen has been the No. 1 cause of sudden liver failure in the United States for at least ten years, reports Bloomberg. The US Food and Drug Administration (FDA) is currently looking into stricter regulation for the compound and has set the maximum daily limit for adults at 4,000 milligrams per day – the equivalent of eight gel tablets of Extra Strength Tylenol.

"With more than 600 (over the counter) and prescription medications containing acetaminophen on the market, this is an important step because it will help remind consumers to always read the label," Johnson & Johnson said in a statement about the new caps.

Two years ago, the FDA lowered the total amount of acetaminophen a prescription pill could contain to 325 milligrams. The federal agency recently announced it would require warnings on prescription drugs with the compound about rare, but serious skin reactions.

The FDA recommends people keep their doctor and pharmacist informed about all the medications they take to make sure they are not being prescribed more than the daily limit. The government agency also recommends people avoid taking acetaminophen with alcohol as it can cause liver damage.

Johnson & Johnson is the largest producer of healthcare products in the world, with about $67 billion in sales last year. The company has occasionally repackaged and relabeled Tylenol over the years and famously issued a nationwide recall of the product in 1982 after seven people died from tampered capsules that had been poisoned.

The company has also addressed liver damage as a result of Tylenol use in the past. In 1994, a warning was added to bottles that warned about combining Tylenol and alcohol. In 1998, a warning to not “exceed recommended dose” was added. In 2004, a specific warning about liver damage was added.

In 2011, Johnson & Johnson removed its Tylenol infant drops – a concentrated formula blamed in some accidental overdose situations. That year it also cut the maximum daily adult dose of Extra Strength Tylenol to 3,000 milligrams and changed "take 2 caplets every 4-6 hours while symptoms last" to "take 2 caplets every 6 hours while symptoms last."

The tragic case of the 1982 recall would eventually become the gold standard for crisis management by a company.

"Johnson & Johnson has effectively demonstrated how a major business ought to handle a disaster,” Jerry Knight wrote in The Washington Post at the time, adding, "this is no Three Mile Island accident in which the company's response did more damage than the original incident.”

In addition to issuing a recall, the company coordinated with police around Chicago, where the poisonings took place, along with the FBI and the FDA. The company’s stocks dropped immediately after the news of the poisonings broke. However, the stock price rebounded less than a year later.