FDA limits acetaminophen dose to improve safety of painkillers

Acetaminophen (Tylenol and generic) can help ease aches and pains, but too much can trigger liver failure and even death. In an aim to improve safety, the Food and Drug Administration Thursday significantly reduced the maximum dose of acetaminophen allowed in combination prescription painkillers, such as Percocet (oxycodone + acetaminophen) and Vicodin (hydrocodone + acetaminophen).

Some strengths of these combo painkillers currently contain up to 750 mg of acetaminophen, but under the new limits that are to be phased in over the next 3 years, the maximum allowed is 325 mg. The FDA is also requiring that the labels of these drugs carry a boxed warning—the agency's strongest caution—about the liver risk posed by acetaminophen.

The new restrictions don't apply to over-the-counter acetaminophen products, such as cough and cold remedies. For a list of all the affected products, click here. 

—Steve Mitchell, associate editor, Consumer Reports Health Best Buy Drugs

—Aaron Bailey