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November 6, 2014 — Almost 80,000 people in the United States are sent to the hospital after overdosing on acetaminophen, the painkilling and fever-reducing medicine in Tylenol and hundreds of other medications.

Acetaminophen is now the leading cause of liver failure in the country, according to the safety advocacy organization Consumer Reports.

Furthermore, it is not clear how much acetaminophen is safe. The recommended dose of over-the-counter medications varies widely. Daily limits for a number of products comes very close to 4,000-mg/day. Taking more than this amount for just a few days can cause brain, kidney, and liver problems.

Consumer Reports recommends, to be on the safe side, take no more than 3,250-mg of acetaminophen per day. It is also important to read the label carefully and avoid combining multiple medications with acetaminophen. Acetaminophen should be avoided entirely in people with liver disease or consumption of 3 or more alcoholic drinks per day.

In July 2014, a study published in The Lancet found that acetaminophen was not effective at treating low-back pain, questioning the near-universal endorsement of acetaminophen in this patient group.

Johnson & Johnson is also facing over 160 lawsuits alleging that over-the-counter Tylenol products can cause serious liver problems, including liver failure, even when taken as directed. These lawsuits have been centralized in a federal Multi-District Litigation (MDL No. 2436) in the U.S. District Court for the Eastern District of Pennsylvania.