The FDA is warning consumers to use caution when taking Extra Strength Tylenol because acetaminophen tablets with more than 325 mg are believed to cause liver damage.

The agency issued a safety alert that reads: “Many consumers are often unaware that many products (both prescription and OTC) contain acetaminophen, making it easy to accidentally take too much.” Because no data exists that demonstrates that taking more acetaminophen provides more benefits that outweigh the possibility of liver damage, the FDA has recommended health care providers and drug manufacturers to cease the prescription and manufacturing of prescription combination drugs containing more than 325mg of acetaminophen.

However, this advice does not apply to over-the-counter medication including Extra Strength Tylenol, and the FDA has yet to address this matter, though the agency has said it plans to in a separate regulatory action.

When taking Extra Strength Tylenol, many patients may not be aware that their prescribed pain medications, such as Percocet, Vicodin and Codeine, are combination drugs that already contain acetaminophen, the FDA said. These types of drugs are prescribed after surgery or injury and many patients are unaware that consuming Tylenol in addition to their combination pain killers may flood their body with a dangerous amount of acetaminophen and potentially cause liver damage.

The potential risk of liver damage is not listed on Tylenol packaging.

Tylenol (Acetaminophen) and Liver Damage

Since 1899, acetaminophen has been widely used over-the-counter analgesic. It has been made and distributed under dozens of drug and brand names, including Tylenol. It is a common remedy for fevers and aids in managing muscle and joint pain.

Tylenol, Johnson & Johnson’s brand name version of acetaminophen, was first designed and sold in 1955. Since its introduction into the North American drug market, Tylenol has become the staple drug in millions of U.S. households. Tylenol can come in various doses including extra strength, children’s, and longer-lasting.

Tylenol has many health and pain relief benefits, but this over-the-counter medication does carry its own set of risks like any other drug.

Some signs of Tylenol (acetaminophen) induced liver damage may include:

• Nausea
• Vomiting
• Tiredness or extreme tiredness
• Loss of appetite
• Sweating
• Bleeding
• Bruising
• Pain in upper stomach
• Yellow tones in skin and eyes
• Some flu-like symptoms

Many consumers are now pursuing Tylenol liver damage lawsuits or joining Tylenol liver damage class action lawsuits.