Editor’s Update: This post was originally published in January 2011 following an FDA announcement about acetaminophen in prescription combination medications. The FDA subsequently limited prescription combination drug products to no more than 325 mg of acetaminophen per tablet, capsule, or other dosage unit. Current acetaminophen FDA guidance continues to warn that taking too much acetaminophen—particularly from multiple medications containing it—can cause severe liver damage.
What Does the FDA Recommend About Acetaminophen Today?
The FDA advises patients to check both prescription and over-the-counter medications for acetaminophen and avoid taking more than one acetaminophen-containing product at a time unless directed by a healthcare professional. Acetaminophen may also appear on prescription labels under abbreviations such as APAP. The FDA states that the maximum total amount for adults and children age 12 and older should not exceed 4,000 mg in 24 hours, although individual products may specify lower maximum doses.
The FDA’s 2011 Acetaminophen Warning
In January 2011, the FDA issued a warning about the risk of liver injury from acetaminophen in prescription pain drugs, such as Vicodin, Percocet, Lortab, Fioricet, and Roxicet. Because acetaminophen is found in many prescription and over-the-counter medications, people may inadvertently take more than recommended when using multiple products. On prescription labels, acetaminophen may also be listed using an abbreviation such as APAP.
Adults and children age 12 and older should not take more than a total of 4,000 milligrams of acetaminophen from all medications in a 24-hour period. It’s fairly easy to exceed that amount if you’re taking several medications and aren’t aware that more than one contains acetaminophen. Acetaminophen overdose can cause severe liver damage and remains a leading cause of acute liver failure in the United States.
In 2011, the FDA announced that prescription combination drug products would be limited to no more than 325 milligrams of acetaminophen per dosage unit and would carry strengthened warnings about the risk of serious liver injury.
“When taken as directed, acetaminophen is a very safe product. Our goal is to make it even safer,” Sandra Kweder, deputy director of the FDA’s office of new drugs, said at a news teleconference.
To your health & beauty,