Tylenol Warnings - Liver Damage, Side Effects in Infants, Recalls
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Tylenol Warnings

Emergency sign with arrow**Please note we are no longer accepting Tylenol cases**

Serious liver damage from Tylenol deserves serious compensation— compensation that the New York-based Sanders Law Firm can deliver. Our experienced team of product liability attorneys effectively leverages the contributions of investigators, healthcare experts and support staff, with a view to winning the most favorable outcomes for clients harmed by Tylenol.

Damages won in a Tylenol lawsuit can include:

  • Payment of past and present medical expenses
  • Compensation for pain and suffering
  • Lost wages and reduction in future earning capacity
  • Funeral expenses
  • Loss of consortium (marital benefits such as spousal intimacy)
  • Projected loss of financial contribution

The personal injury lawyers at The Sanders Firm address the concerns of their clients with compassion and integrity, while aggressively pursuing justice on their behalf. This blend of conscientious, empathetic and trustworthy service with unswerving advocacy on behalf of aggrieved parties has kept us in business for over 40 years, engendering the trust of clients both old and new.

If you or a loved one has suffered serious liver damage or death because of Tylenol usage, consider a free consultation with The Sanders Firm. A no-charge initial review will assess your case and appropriate legal recourse. You can get started by calling 1-800-FAIR-PLAY.

FDA warnings

Tylenol and other medicines containing acetaminophen have become the source of a slate of FDA rulings in recent months.

At the start of this year the Food and Drug Administration (FDA) banned prescriptions of combination medications containing more than 325 milligrams of acetaminophen per pill, because of long-standing concerns about liver damage associated with acetaminophen. These concerns go all the way back to the 1970’s, when the FDA first made known the dangers to the liver posed by acetaminophen, but only quite recently did the FDA begin to institute more rigorous measures to protect consumers.

In a January statement, the FDA said: “There are no available data to show that taking more than 325 mg of acetaminophen per dosage unit provides additional benefit that outweighs the added risks for liver injury. Further, limiting the amount of acetaminophen per dosage unit will reduce the risk of severe liver injury from inadvertent acetaminophen overdose, which can lead to liver failure, liver transplant, and death.”

The FDA said doctors can still prescribe two-pill doses, for a total dose of 650 mg, when medically necessary and appropriate.

The FDA has also asked drug-makers to stop producing combination prescription medications with higher doses of acetaminophen, such as painkillers commonly prescribed after injuries, surgeries and dental procedures. More than half of manufacturers have complied, according to the FDA statement.

In March the FDA rescinded its approval for all medications containing more than 325 mg of acetaminophen.

Some non-prescription painkillers, such as Extra Strength Tylenol, contain 500 mg of acetaminophen in each pill. Tylenol’s maker Johnson & Johnson recently announced it was adding warning labels to bottle caps to remind consumers to read the label for dosing and safety instructions. The new cap label reads: “CONTAINS ACETAMINOPHEN” and “ALWAYS READ THE LABEL.”

These measures come in the context of pervious health risks involving Tylenol. Only last year Johnson & Johnson was forced to recall batches of the grape oral suspension form of Tylenol for infants, because of a faulty dispenser. Several years prior, the company faced an even more major recall of children’s Tylenol and other children’s medicines.

Dangers of acetaminophen

Overdoses from acetaminophen send 56,000 people to emergency rooms and kill about 500 each year, according to the FDA and the Centers for Disease Control (CDC). The drug is a leading cause of acute liver failure.

Cases of severe liver injury with acetaminophen have occurred in patients who:

  • Imbibed more than the prescribed dose of an acetaminophen-containing product in a 24-hour period
  • Took more than one acetaminophen-containing product at the same time
  • Drank alcohol while taking acetaminophen products

Inadvertent overdose from prescription combination drugs containing acetaminophen accounts for nearly half of all cases of acetaminophen-related liver failure in the United States, some of which end in liver transplant or death.

Because acetaminophen is widely used as an over-the-counter (OTC) pain and fever medication and is often combined with other ingredients, such as cough and cold ingredients, it can be unintentionally abused by uninformed consumers.

More than 600 common over-the-counter and prescription 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, contain the ingredient acetaminophen.

Litigation over Tylenol side effects

Thanks to litigation, Johnson & Johnson has been updating Tylenol safety warnings since the 1990’s. A 1994 lawsuit brought by the former aid to President George H.W. Bush, Antonio Benedi, who fell into a coma and underwent an emergency liver transplant after mixing Tylenol with wine over dinner, generated the company’s first label warning (about liver damage when Tylenol is taken with alcohol).

A jury awarded Benedi $8.8 million in damages after concluding he was insufficiently warned by the drug manufacturer. Several years later the FDA made the alcohol warning mandatory for all manufacturers of acetaminophen.

Still, because more than a million Americans continue to take Tylenol, the risks of liver injury remain serious and many consumers have inadvertently suffered unforeseen costs.

Since June of last year alone, more than 187 Tylenol lawsuits have been filed across the country contending liver damage.


  1. USA Today, “FDA warns against high-dose prescription acetaminophen,” https://www.usatoday.com/story/news/nation/2014/01/15/fda-acetaminophen-warning/4489193/

  2. USA Today, “Company tries new cap to curb Tylenol overdoses,” https://www.usatoday.com/story/news/nation/2013/08/29/new-cap-tylenol-overdoses/2728955/

  3. FDA, “FDA recommends health care professionals discontinue prescribing and dispensing prescription combination drug products with more than 325 mg of acetaminophen to protect consumers,” https://www.fda.gov/Drugs/DrugSafety/ucm381644