Find Information About:

Drugs & Supplements

Get information and reviews on prescription drugs, over-the-counter medications, vitamins, and supplements. Search by name or medical condition.

Pill Identifier

Pill Identifier

Having trouble identifying your pills?

Enter the shape, color, or imprint of your prescription or OTC drug. Our pill identification tool will display pictures that you can compare to your pill.

Get Started

My Medicine

Save your medicine, check interactions, sign up for FDA alerts, create family profiles and more.

Get Started

WebMD Health Experts and Community

Talk to health experts and other people like you in WebMD's Communities. It's a safe forum where you can create or participate in support groups and discussions about health topics that interest you.

  • Second Opinion

    Second Opinion

    Read expert perspectives on popular health topics.

  • Community


    Connect with people like you, and get expert guidance on living a healthy life.

Got a health question? Get answers provided by leading organizations, doctors, and experts.

Get Answers

Sign up to receive WebMD's award-winning content delivered to your inbox.

Sign Up

Pain Management Health Center

Font Size

FDA Warns of Acetaminophen in Prescription Pain Drugs

Percocet, Vicodin, Other Combination Pills to Get Dose Limit, "Black Box' Warning


"We have not made a decision about what action to take with over-the-counter products. We continue to consider our options," Kweder said.

Over-the-counter "extra strength" formulations of cold and cough remedies contain 500 milligrams of acetaminophen per pill or spoonful (or even more in extended-release formulations).

"It is extremely poor judgment on the part of the FDA to have failed to take action concerning this major source of acetaminophen consumption and, consequently, acetaminophen toxicity," Sidney Wolfe, MD, director of Public Citizen's Health Research Group, says in a news release.

Pain Pills Still Equally Effective, Still on the Market

Kweder said that limiting the acetaminophen in prescription pain pills to 325 milligrams will not make the drugs any less effective.

Yet she also said that acetaminophen is included in these drugs as an additional source of pain relief -- and not as a way of limiting drug abuse by making the opioid drugs toxic at high doses.

At the two-day June 2009 advisory committee meeting, Cleveland Clinic pain expert and panel member Edward Covington, MD, took a different view.

"Basically we have limited [hydrocodone] abuse, as was said yesterday, by combining it with a poison [acetaminophen] so that you can't abuse it as easily as you can abuse OxyContin," Covington said. "And the whole idea of protecting the public by mixing a poison with your medicine I find troubling, and in essence that's what we've done."

FDA Advice to Patients Taking Acetaminophen-Containing Drugs

Here's the FDA's advice to people who are taking prescription pain drugs that contain acetaminophen:

  • Acetaminophen-containing prescription products are safe and effective when used as directed, though all medications carry some risks.
  • Do not stop taking your prescription pain medicine unless told to do so by your health care professional.
  • Carefully read all labels for prescription and OTC medicines and ask the pharmacist if your prescription pain medicine contains acetaminophen.
  • Do not take more than one product that contains acetaminophen at any given time.
  • Do not take more of an acetaminophen-containing medicine than directed.
  • Do not drink alcohol when taking medicines that contain acetaminophen.
  • Stop taking your medication and seek medical help immediately if you think you have taken more acetaminophen than directed.
  • Stop taking your medication and seek medical help immediately if you experience allergic reactions such as swelling of the face, mouth, and throat, difficulty breathing, itching, or rash.

Today on WebMD

pain in brain and nerves
Top causes and how to find relief.
knee exercise
8 exercises for less knee pain.
acupuncture needles in woman's back
How it helps arthritis, migraines, and dental pain.
chronic pain
Get personalized tips to reduce discomfort.
illustration of nerves in hand
lumbar spine
Woman opening window
Man holding handful of pills
Woman shopping for vegetables
Sore feet with high heel shoes
acupuncture needles in woman's back
man with a migraine