FDA limits amount of acetaminophen in prescription drugs
January 13th, 2011
03:15 PM ET

FDA limits amount of acetaminophen in prescription drugs

Manufacturers of prescription drugs containing acetaminophen are being asked to limit the dosage of the drug and add a liver toxicity warning to product labels, the Food and Drug Administration announced Thursday.  This so-called "boxed warning" is the agency's strongest warning for a prescription drug.

Makers of prescription products that include acetaminophen, a popular pain and fever reducer better known under the brand name Tylenol, will be required to limit the amount of the drug to no more than 325 milligrams (mg) per tablet or capsule.  Currently some products contain between 500 mg  to 750 mg per dose.

"FDA is taking this action to make prescription combination pain medications containing acetaminophen safer for patients to use," said Dr. Sandra Kweder, deputy director of the Office of New Drugs in FDA's Center for Drug Evaluation and research (CDER). "Overdose from prescription combination products containing acetaminophen account for nearly half of all cases of acetaminophen related liver failure in the United States, many of which result in liver transplant or death."

Acetaminophen is often used in combination with opioids like oxycodone (Percocet), hydrocodone (Vicodin) and codeine (Tylenol with Codeine).  In 2008 nearly 200 million prescriptions for acetaminophen/opioid combination products were written, according to the FDA.  In 2009,  an FDA advisory committee recommended putting a stronger warning about the risk of severe liver damage on the label of all prescription products containing the drug.

Kweder stresses when taken as directed, acetaminophen is perfectly safe but can be extremely dangerous if the recommended dose is exceeded. The current maximum dose is 4,000 mg within a 24-hour period.  She says patients taking a higher dose prescribed by a doctor are in no immediate danger and can continue taking the medication as prescribed.

Over-the-counter acetaminophen will not be affected by this new action, although the FDA is considering changes with these medications too.  OTC products typically contain either 325 mg (regular strength) or 500 mg (extra strength) of acetaminophen.  One reason that these drugs aren't included in today's action, says Kweder says, is that they are already more clearly labeled than the combination drugs.

Unlike over-the-counter products that are clearly labeled, Kweder says, it's not always clear to consumers that acetaminophen is in the prescription products they are taking because they're not familiar with the abbreviated name–APAP–often used in the packaging. "One of the real challenges is patients taking these prescription products don't know they are taking acetaminophen at all," she said.  So it's possible for someone to take the prescription drug and then reach for an OTC product Acetaminophen, which can quickly add up to too much of a good thing. "They don't realize that they are overdosing," Kweder told reporters in press conference.

Neurologist Dr. John Markman is a pain management expert and researcher at the University of Rochester in New York.  He says today's action strikes the right balance. "I think they got it right. I think they made a great public health decision by balancing the need for access to these important pain treatments and at the same time taking steps to make them safer." Markman said. "The risk of liver injury with acetaminophen when taken in excessive doses can be a significant problem for an individual patient as well as at a public health level, but so is the problem of chronic pain, so trying to find a balance of addressing both of these public health problems is delicate work."

But consumer advocacy group Public Citizen says the agency should have addressed the OTC drugs first.

"The measures announced today by the Food and Drug Administration (FDA) concerning acetaminophen in prescription drug products are certainly a step forward, but they entirely fail to address the greater issue of over-the-counter (OTC) use of this drug and to implement strong recommendations made by three FDA advisory committees in June 2009 about this problem," said Dr. Sidney Wolfe, Director, Public Citizen's Health Research Group. "It is inexcusably 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."

The shift away from higher doses of acetaminophen will be phased in over the next three years. Prescription products will continue to be available during this transition period and the FDA says they anticipate no shortage of pain medication.

In the meantime the FDA has the following advice for consumers:
*Carefully read all labels for prescription and OTC drugs
*Ask the pharmacist if your prescription contains acetaminophen
*Don't take more than 1 product that contains acetaminophen
*Don't take more than the maximum daily amount
*Avoid drinking alcohol while taking acetaminophen
*Don't stop taking acetaminophen without first talking to your doctor

soundoff (95 Responses)
  1. Mike Masters

    More Cow Bell!

    January 13, 2011 at 17:08 | Report abuse | Reply
    • Wzrd1

      Yeah, because the ENTIRE WORLD has noticed the lethal effects if Acetaminophen before the US bothered to notice.
      I have an idea! Since it's harmless on the planet Stupidia, DO take 7000mg of the sh!t.
      Let us know where you wish to be buried.
      Because, your liver will be useless, even for worm food.

      January 14, 2011 at 01:16 | Report abuse |
  2. MedicineStoleMySocialLife

    've never understood why APAP is the drug of choice for so many combination drugs. Most of the reasons people are prescribed these drugs is because of pain due to some kind of inflammation and acetaminophen is NOT an anti-inflammatory, it only works on pain pathways in the nervous system. Why wouldn't you go with an NSAID like ibuprofen or naproxen and kill 2 birds with 1 stone. Why go with a drug that can be toxic to your liver simply if the right liver enzymes are activated, when you could go with one that is far less toxic and actually targets the root of the problem. The only other formulations that i've seen use aspirin instead, any maybe its just been my experience but those almost never seem to be prescribed.

    I also fully agree with what was said about people not recognizing APAP as acetaminophen. It took me till several months into medical school before I realized that myself.

    January 13, 2011 at 20:07 | Report abuse | Reply
    • Other Considerations

      People have stomach problems with Motrin like meds and I got heart problems with Aleve etc. There are other considerations other than the liver, but I think people need to limit the Tylenol and be very careful.

      January 13, 2011 at 21:05 | Report abuse |
    • samdog

      In general, I agree with what you're saying. However, you've got to consider these drugs are almost always prescribed for post-surgical pain. Recent surgery + NSAIDS can cause nasty consequences including fatal bleeding–not to mention all the other side effects (eg, GI). Acetaminophen doesn't have this issue. Other than that, I see no reason why it should be allowed to be combined with OTC drugs.

      January 13, 2011 at 21:47 | Report abuse |
    • Cat

      Not everyone can tolerate NSAIDS. I have a chronic pain condition I don't really take anything for it because I can't tolerate NSAIDS and I don't like the way opioid pain meds make me feel. I'm even allergic to some NSAIDS.

      So it's not so simple.

      January 13, 2011 at 22:04 | Report abuse |
    • arun

      I am hoping you are far far away from becomming a dr yet... couldn't recognize APAP/ acetaminophen and your comments
      about NSAIDS as being safe, please do your research before proclaiming your docterness...

      January 13, 2011 at 22:13 | Report abuse |
    • PharmD

      Another reason ibuprofen is not used in as many combination drugs is that it exerts different effects at different doses. It is used to reduce fevers at low doses, and at higher doses as an anti-inflammatory and pain reliever. Usually, it takes a larger dose of ibuprofen (600-800mg) to provide the same pain relief as a 'normal' dose of acetaminophen (325-500mg). Because the frequency of administration for most narcotic combo meds is 4-6 times/day, it is easier to exceed the maximum daily dose for ibuprofen than acetaminophen.

      Also, as mentioned by others, acetaminophen is generally better tolerated than ibuprofen and is safer to give to patients with multiple chronic diseases (i.e. – heart problems, GI bleeds, reduced kidney function, etc.).

      January 13, 2011 at 22:14 | Report abuse |
    • RPh

      What PharmD failed to mention (maybe they don't teach this in Pharmacy school anymore?) is that the real reason that Tylenol was added to these meds in the first place was to decrease the abuse potential of the opiod and not because it really added much to the pain relief from the med. This is true because Tylenol/Acetaminophen does NOT dissolve in water, so dissolving a Tylenol containing product in water and attempting to inject it would lead to the injection of Tylenol crystals into your bloodstream. Amoung other things, this can lead to some nasty lung damage. This is why Codeine by itself is in a stronger regulatory category than Tylenol with Codeine, and also explains that an older prescription combination headache medicine is a controlled substance when it contains Aspirin, but not a controlled substance when it contains Tylenol.

      So... the reason that Tylenol is added is to keep morons from injecting it Now you know.

      January 13, 2011 at 22:59 | Report abuse |
    • CSS

      Well, NSAIDs will cause GI bleed and increase heart disease risk with prolong use. It is not "may cause," but "it will cause" with prolong use. There are lots of people with chronic pain who will need pain medication for long time and NSAIDs in these people will cause death at some point. Trust me, I am a doctor.

      January 13, 2011 at 23:02 | Report abuse |
    • Richard

      The American state has had no compunction about killing tens of thousands of addicts by denaturing untaxed ethyl alcohol, and it had none about denaturing opioids with acetaminophen. It's great news to see them backtrack on this cruel policy.

      January 13, 2011 at 23:04 | Report abuse |
    • johnson

      1 reason why i believe apap is the chosen drug to be combined with any prescription drug such oxycodone, codeine, hydrocodone, is because any NSAID will be to harsh on most patients stomach. Especially if the patients are in pain and wont be able to eat all the time. NSAID's such as ibuprofen and naproxen will upset the stomach, which is why its recommended it be taken with food.

      January 13, 2011 at 23:11 | Report abuse |
    • PharmD

      RPh – I definitely don't remember learning that in pharmacy school. That is great to know, thank you!!

      January 13, 2011 at 23:15 | Report abuse |
    • Albert Mintol

      You mention you have medical training/classes and then go on to say there are no formulations you know of that uses NSAIDs etc. Maybe you forgot about Vicoprofen? Hydrocodone/Ibuprofen combinations are common (AKA Vicoprofen) in most fields and are favored by dentists. You make a good point regarding acetaminophen being next to useless for most pain patients compared to the anti-inflammatory effects of NSAIDs (Advil/Ibuprofen). I was on an APAP combination pain relievers for years and made sure to stay well under "safe" levels, though I was not happy taking acetaminophen daily. I asked my doctor to switch me to a non-combination IR pain med that I take along with NSAIDs and this provides much more effective pain control without frying my liver and kidneys. (Some damage can be done to your kidneys with excessive/pro-longed APAP consumption.)

      January 13, 2011 at 23:50 | Report abuse |
    • Daina

      It took you years of medical scholl to realize APAP was acetaminophen? Is this Frank Burns??? It takes one semester of pharmacololgy for most...Itaht isn't something I would share with the class...

      January 13, 2011 at 23:54 | Report abuse |
    • Daina

      And...if they replace it with Vicoprofen the FDA will put out a GIB alert.

      January 13, 2011 at 23:56 | Report abuse |
    • SmarterThanTheAverageBear

      Whoever can't read labels and educate themselves on what they're putting in to their bodies is in trouble. Maybe we should have life guards at people's private pools, because swimming COULD be dangerous. The FDA likes to think they know more than medical professionals be putting labels on PERSCRIPTION drugs. I'm sorry if ignorant people have issues with what they're doing to their bodies, but the FDA limits far too many drugs to the people that understand how they work, why they need them, and that exceeding the doctors dosing is an awfully stupid idea.

      January 14, 2011 at 01:57 | Report abuse |
    • bixi

      What ever happened to good ol' APC w Codeine, best pain reliever ever on the market. We had ASA taken away by the government because of 'Reyes'...Asprin continues to be the best anti-inflamatory, anti-pyretic drug there is. I have used it for 65 years and have not had a problem. APAP is liver toxic, always has been and always will be. Asprin relieves arthritic pain better than any NSAID out there. And we continue to listen to the 'Government' rather than our bodies. I'm glad they are limiting tylenol...one good action for sure.

      January 14, 2011 at 03:09 | Report abuse |
    • Suzi

      I can't take ibuprofen due to the fact it causes water retention 1 ibuprofen and I am carrying around pounds of water within hours. Which can raise my blood pressure. Sometimes you have to choose the lesser of 2 evils.

      January 14, 2011 at 08:54 | Report abuse |
    • Janice

      Many people, including myself are allergic to NSAID's and I am a "bleeder" so cannot take aspirin. There are many reasons that someone is prescribed these other medications. I know, from my own experience, that there are many good natural alternatives to prescription and over the counter medications. One, in particular, is called Ultra-Inflam 360 X. It works really well on arthritis. All it is is all of the amino acids and vitamins your body already has. It's not cheap, but neither is losing a liver!!!!

      January 14, 2011 at 10:35 | Report abuse |
  3. Patton

    You are right about this, except that a surprising number of people are allergic to NSAIDS or have GI intolerance or a history of esophagitis/gastritis from them. Therefore, it is actually safer to have acetaminophen coupled with the narcotic, and simply use an additional OTC NSAID with them if the patient is able. One narcotic, Vicoprofen, has hydrocodone and ibuprofen combo and it works well–probably cheaper though to go with generic ibu and simple plain ole narcs.

    January 13, 2011 at 20:15 | Report abuse | Reply
    • MedicineStoleMySocialLife

      That is a good point, and I guess any drug will have its limitations. In any case, this new warning label should definitely help people to be more informed about what they take when they're taking these drugs.

      January 13, 2011 at 21:18 | Report abuse |
  4. Dea

    I can't tolerate most NSAIDS and on occasion have to take prescription drugs with APAP in them , in addition to my regular stuff. I already know how how much I can take and in which combinations because I am a daily user for chronic pain. However, someone like my son, who rarely takes meds at all, would not know that unless he asks, and he would have no clue that he needs to ask if there is no warning label.

    So, this is a good thing. People need information to be able to take control of their own health, so yes, this is a very good thing.

    January 13, 2011 at 21:06 | Report abuse | Reply
  5. Claire

    They're all poison to me, and upset my GI system in various ways. I just limit it and try to use Aspercreme, over-the-counter patches, or something external so my GI system doesn't get blasted.

    January 13, 2011 at 21:24 | Report abuse | Reply
  6. Katie

    I recently had shoulder surgery and it took me one whole month to get proper pain medication. I kept calling the office to complain and they kept telling me to take anti-nausea medication, which, when combined with the pain medication, lowered my blood pressure so low I couldn't stand. Finally I got the doctor to listen to me – I didn't want more pills, I wanted something different. Everything with Tylenol added made me sick to my stomach. Why is it in pain medication at all, and why is that the drug of choice for post-op, when inflammation is definitely a factor? And why is so much of it added? The Percocet I had contained 500mg of Tylenol and I was told to take two pills if the pain was bad – that's 1000 mg of Tylenol right there. My husband received a 'stronger' medication for a similar surgery, and the only thing stronger about it was MORE Tylenol – 750mg. It doesn't take much Tylenol to give you liver problems. The wisdom about pain management is that you take the medication before you really need it, then you don't have to take as much and it works better. But if you're only supposed to take 2000mg of Tylenol in a 24 hour period and your medication contains 500 – 750 mg per pill, you can max out in as little as eight hours. What are you supposed to do the other sixteen hours?

    January 13, 2011 at 22:18 | Report abuse | Reply
  7. Katie

    My doctors told me 2000mg in a 24 period was the safe dose, not 4000 mg.

    January 13, 2011 at 22:22 | Report abuse | Reply
    • Courtney

      The MAX dose in 24 hours is 4000 mg.

      January 13, 2011 at 23:54 | Report abuse |
    • Hospital Pharmacist

      Careful saying 4000 mg as a blanket statement. Concurrent disease states such as hepatic insufficiency change the max daily dose to 2000 mg.

      January 14, 2011 at 09:39 | Report abuse |
    • Katie

      I called by doctor this morning, and then my surgeon's office. Both repeated 2000 mg per day is the safe dose. It's not based on me being a small female. That is the current recommended dose for everybody. I didn't just hear it from them, either. The nurse in the ICU, where I spent 18 hours after surgery because of my low blood pressure cautioned me about it too, telling me that with all the medication I was supposed to be taking (pain med, muscle relaxant, anti-nausea med) I should make sure I wrote down what I took and when so that I didn't exceed the daily 2000 mg of Tylenol levels. Don't know why anyone here is saying differently.

      January 14, 2011 at 12:25 | Report abuse |
    • Courtney

      2000 mg of Tylenol in a day is a "safe dose", and maybe your doctors only want you to take a maximum of 2000 mg of Tylenol per day for you personally; everyone is different. HOWEVER, the generally accepted maximum dose for people who are generally healthy with no hepatic impairment or other conditions that can increase the risk of liver damage is 4 g or 4000 mg per day.
      Here are some of the examples directly from most trusted drug information resources, Micromedex and Clinical Pharmacology:


      Fever: 650 to 1000 mg ORALLY every 4 hours as needed, maximum 4 g/day
      Pain (Mild to Moderate): 650 to 1000 mg ORALLY every 4 hours as needed, maximum 4 g/day
      Pain (Moderate to Severe); Adjunct: 650 to 1000 mg ORALLY every 4 hours as needed, maximum 4 g/day

      Clinical Pharmacology

      Oral or Rectal dosage (regular-release formulations):
      Adults, Adolescents, and Children >= 12 years: 325—650 mg PO or PR every 4—6 hours, as needed. Alternatively, 1000 mg PO or PR, 2—4 times per day can be given. It is important to note that doses effective for acute pain relief (1—2 tablets/day) may not be effective in chronic pain states, which require higher daily doses. Do not exceed 1 g/dose or 4 g/day.

      Obviously with hepatic impairment dosage adjustments are necessary. This is where 4000 mg comes from.

      January 14, 2011 at 17:13 | Report abuse |
    • Katie

      If you read what I said, you'd know that I specifically asked two different doctors if they were talking about me. They said NO, THE SAFE DOSE FOR TYLENOL IS 2000 mg /DAY. FOR EVERYONE, not just me.

      January 14, 2011 at 17:29 | Report abuse |
    • Mark D

      Katie I could list you a 1000 places where it states that the max dose ( for someone with no hepatic issues ) is 4000mg/day. Just because you spoke on the phone to two physicians doesn't make you some sort of expert and mean that all of the resources that say 4000 mg are wrong. There must be something in your med history that make YOUR physicians want YOU to only have a max of 2000mg, or you have drs with very conservative outlooks on medicine ( not a bad thing).

      January 14, 2011 at 20:37 | Report abuse |
  8. Bob

    The larger problem is, medicine dosing is dumbed-down.

    The actual amount you're supposed to take is intended to vary by body weight. If you're a 5'2", 120-lb woman, a certain dose is correct; the same does for a 6'6", 240lb male won't do anything for you!

    But thanks to the jerks at the FDA, we get "standard doses" that are meaningless for people on the upper range, and instructions like "take one... take two if necessary", where one is inadequate but taking two is 50% above the needed dose.

    Thanks for nothing, FDA.

    January 13, 2011 at 22:27 | Report abuse | Reply
    • PharmDStudent

      Interesting theory, however not all medications are dosed based on weight. It is important to take into account the pharmacokinetic and pharmacodynamic properties of the drug. For example, the volume of distribution of a drug and protein binding are important. Also, keep in mind that the liver (where many drugs are metabolized) is not necessarily that much larger/ smaller in different adult populations (if you're twice as heavy as you ideally should be, that doesn't mean that your liver is also twice as big). Are there drugs that should be dosed based on weight – yes – and they are. Not all drugs need to have weight based dosing however.

      January 13, 2011 at 23:42 | Report abuse |
    • LastToTouchYou

      Dear PharmDStudent.....I perform autopsies and rule on the cause of death about 10-20 times a day for the last 23 years.

      I will not re-read this comment nor spell check it as it is barely worth my time to comment at all. If that allows you some sort of reasoning to disregard my post than I will understand your aforementioned comprehension ability. Please allow me to correct an inadvertent false theory you have proclaimed... and in which you state that

      "Not all medications are dosed based on weight. It is important to take into account the pharmacokinetic [writer meant PK] and pharmacodynamic [writer meant PD] properties of the drug. For example, the volume of distribution of a drug and protein binding are important. Also, keep in mind that the liver (where many drugs are metabolized) is not necessarily that much larger/ smaller in different adult populations (if you're twice as heavy as you ideally should be, that doesn't mean that your liver is also twice as big). Are there drugs that should be dosed based on weight – yes – and they are. Not all drugs need to have weight based dosing however."

      Absolutely FALSE! I want to stress that I have performed thousands and thousands of autopsies over my career and I have never once seen a 300 pound person have the liver or heart of a 200 pound person. Why are the hearts and livers enlarged? Because the human body is amazing; in which it compensates by growing larger to pump or distribute more! Surely, it can grow too large and defy its reasons...but since it has no "brain" it cannot comprehend, therefore it's ability to save itself fails. Much like the intestines wrapping themselves and cutting off the flow of feces, resulting in death of the individual (medical terminology purposely avoided so everyone understands what I am saying).

      In closing, you are not only wrong, you are absolutely wrong; inherently wrong; perceptually wrong and educationally wrong in your fallacious comment that weight has no bearing. Scary!

      You are not serious about being a Pharmacy Student are you? Please tell me NO! If you are...please let me know what school you attend and I can contact your educators to let them know your understanding of the teaching you have comprehended. Disgusting!

      A very simple mathematical description (dating to the 1800’s) is

      The most recent equation is

      A hypothesis argument is

      ….but does not apply to your ignorant conclusion at all! Not even remotely!

      If you still disagree I would very much enjoy writing an article based on YOU and your inability to posy in forums based on your absolute lack of intellect, false understanding and true ignorance of how the basic human body functions. I admit that I am horrified by your post and find you directly frightening to any future career in mu industry.

      I you have any aforementioned rebuttal please refer to my experience below. Shall God help you in your educational understanding of basic Pathology and forensic rulings! I intend to make sure you do not get ANY degree unless you publicly post or rebuke your previous comments. In other words, you have entered my examination slab….now why did you die? You are either an imposter or a liar…if not…you will NOT graduate. So help me God.


      John Adams, MD, Pathologist
      Division – Chicago, Illinois
      Chief Medical Examiner, Chicago School of Medicine

      Previous Experience: Medicolegal Examiner, NY City, NY – Over 10,000 Autopsies
      Director – Forensic Training, Seattle Washington
      Senior Forensic Pathologist, Harvard Medical School
      Director, Yale School of Medicine

      January 14, 2011 at 02:35 | Report abuse |
    • LastToTouchYou

      My mathamatical formulas did not post because this formum cannot compute ...so I will try again

      cx(p-e) to the multiple of "a" (q-e) t the multile of b = a' (p'+e) a' square(q'+e')


      If you understand this you understand the rest of my equations...if not...oh my!

      Good Luck!

      January 14, 2011 at 02:46 | Report abuse |
    • Casual Observer

      Wow doc, way to over-react... the poor student said "is not necessarily that much larger/ smaller" so how absolute is the student in his or her assertions with the phrase "not necessarily that much"? There is obviously wiggle room implied there and the statement is not meant to be absolute. Do you disagree?

      Where the student said "Not all drugs need to have weight based dosing..." I took it to mean that the student implied that for some drugs, an adult does not need weight adjustment, and for some drugs there does need adjustment. Once again, I do not see a statement of absolution. Do you disagree?

      I get the feeling that you are probably a physician that would give the shivers to anyone that had to round with you, but I will include the "probably" here because I hesitate to make that statement as an absolute for fear that you would track me down and have my license revoked and my degrees stripped. Now, take it easy on the students and try to remember back through the centuries to when you were a student also.

      January 14, 2011 at 08:16 | Report abuse |
    • Jeff

      And this, Doc, is exactly why you're a pathologist versus a physician that can interact with people without being a total a$$. Enjoy your work with the slabs, and try posting when it's not the middle of the night...

      January 14, 2011 at 10:43 | Report abuse |
  9. bob

    how about no combination of opoid and apap in hydrocone pain meds. its one of the only pain meds that is not in a pure form. worked wonders for my pain, however i stopped due to the apap. i take pure oxycoxone now, however i believe the norco worked better my pain. and over a long period i built up tolerance and would have had toxic doses of apap even though the higher hydrocone doses would be safe with minimum stress on liver enzymes and health. as long as your disciplined enough not to abuse. most people with chronic pain do not get addicted. addiction is very different than dependancy, il get off my soapbox now

    January 13, 2011 at 22:30 | Report abuse | Reply
    • Karen

      I agree. Get rid of all the tylenol in these drugs. If you want to add additional Tylenol, get a bottle at the drug store. It's that easy. I also have chronic thoracic nerve pain that radiates through to my chest. Very disconcerting to say the least. Sometimes it gets so bad I can hardly breathe. Sometimes not so bad. There are occasions I just want to try ONLY 3 Tylenol. BUT if that doesn't work, the only medications i have left here also contain Tylenol. Then what do I do ? Go to the emergency room for pain relief because I can't take any more Tylenol ? That's just plain ridiculous. If people want to add Tylenol let them, but stop automatically putting it in every drug. No wonder people OD on the stuff. Most of the time in my case anyway, I'd get just as much relief from eating an M&M.

      February 18, 2011 at 10:43 | Report abuse |
  10. David Hernandez

    Please correct me and my PCP. He recently informed that the medication in in Advil Ibuprofen can and does cause more damage then the acetaminophen which is in Tylenol. Now with this report I have it very hard to choose the pain/fever/and sleep reliever that can best help me. Is acetaminophen being placed in the same class at ibuprofen?

    Thank you

    David Hernandez The Bronx, New York City USA

    January 13, 2011 at 22:31 | Report abuse | Reply
    • Courtney


      Your PCP is completely correct about Advil being more problematic than Tylenol. This liver toxicity issue with Tylenol only occurs at doses that exceed 4000 mg daily. At normal doses of Tylenol, it is safe and effective for pain relief. This report is more for people who do not understand the maximum dose and its consequences, and end up taking too much. Advil can actually cause more issues because of the many body systems it affects. It can causes more side effects such as GI bleeding, increased heart risk, etc.

      -Courtney (current pharmacy student)

      January 13, 2011 at 23:07 | Report abuse |
    • Greenie

      The main difference between the two drugs is that ibuprofen can build up to toxic levels in your body over time. The longer you use it, the more problems it can cause. You can't overdose on it at any one time, but long-termn use can be dangerous,.

      Acetaminophen does not stay in your body, cannot build to toxic levels over time. But you can overdose on it and cause liver damage if you take too much in a short period of time. The FDA is trying to deal with the fact that people don't know they are taking acetaminophen in many cases, or how much, when it is an ingredient in other drugs. You could, for example, take both Tylenol and Percoset, not understanding that the Percoset has acetaminophen in it, and cause an overdose.

      But acetaminophen is perfectly safe when taken as directed. Note that hospitals routinely dispense acetaminophen, not ibuprofen, for minor pain.

      January 14, 2011 at 02:09 | Report abuse |
    • Katie

      "This liver toxicity issue with Tylenol only occurs at doses that exceed 4000 mg daily." This is simply not true. Toxicity can and does occur at doses that exceed 2000mg daily. Tylenol toxicity can even occur at lower levels if the patient regularly drinks alcohol.

      January 14, 2011 at 12:17 | Report abuse |
  11. bob

    i avoid nsaids unless the pain gets so bad that i cant walk or talk. ibuprofen is said to triple chance of stroke all other nsaids i double risk. im not a dr. i read that today as matter of fact. take vioxx for example.

    January 13, 2011 at 22:37 | Report abuse | Reply
  12. bob

    believe it or not vicodin hp i believe it is has 1100 mg per pill es 750

    January 13, 2011 at 22:43 | Report abuse | Reply
    • Courtney

      Vicodin HP only has 660 mg of acetaminophen in each tablet...

      January 13, 2011 at 23:08 | Report abuse |
    • Guest

      Vicodin HP is 10mg of Hydrocodone and 660mg of Acetaminophen

      January 13, 2011 at 23:18 | Report abuse |
  13. antonio

    hmmm....makes me think if thats because they are preparing us for federal healthcare. im thinking that they dont want to foot the bill for overdosaged prescripsions of acephetomine so they are "phasing" us down to lower levels so its not a shock when the feds take over our health.

    January 13, 2011 at 23:05 | Report abuse | Reply
    • krozareq

      More like the pharmaceutical companies lowering dosages so that Germany can get them on our dime just like they do their medications currently. Americans subsidize the world's medication costs. Dems being in bed with the pharmaceutical companies didn't do a thing about this in the massive health care bill. Obama just forked more money over to hospitals and pharmaceutical companies. I am not for regulating med prices to cause a downfall in profit. I am for it to make the playing field a bit more level. Last I checked people in Western Europe do financially better than Americans.

      January 14, 2011 at 01:12 | Report abuse |
  14. Lisa

    I have been taking pain meds for some time due to a pain disorder. A recent lab result showed that the liver was excreting enzymes that indicated toxicity. I had been taking Percocet. I asked my doctor for medication that did not have Acetaminophen and he gave me the pain medication (oxycodone) without the Acetaminophen. Even though I was taking what the FDA deemed was a safe amount of Acetaminophen, five weeks after discontinuing, my liver labs were back to normal. A very strong argument in favor of this action by the FDA and long overdue. There are many people who must take pain medications for long periods of time, taking the Acetaminophen out should be a no-brainer since we all know Acetaminophen has the potential to cause liver damage.

    January 13, 2011 at 23:19 | Report abuse | Reply
    • Codifex Maximus

      Seems to me, based on this person's post, that labs to determine liver enzyme toxicity should be performed on anyone taking regular doses of acetaminophen.

      January 14, 2011 at 00:27 | Report abuse |
    • AddictionDisease

      Re: Lisa
      Treating liver disease due to Tylenol toxicity is far easier than treating addiction to narcotic over use. As a mental health professional who treats people with narcotic addiction, I can bet you'd rather have a temporary issue with your liver rather than a life altering, all-consuming drug addiction. No, not all narcotic use leads to addiction, but it is very hard for a patient to monitor, especially when the euphoria from the narcotics sets in.

      January 15, 2011 at 00:26 | Report abuse |
  15. xcet

    Damn, now they're making it harder to kill ourselves. You would think that they could use the estate taxes right about now.

    January 13, 2011 at 23:40 | Report abuse | Reply
    • Ben Franklin

      I take it you haven't been following the news. Obama agreed to continue the low estate tax to get another year of unemployment – horsetrading with the Republicans, who insisted on lower taxes for the rich, including the banksters who tanked the world's economy.

      January 14, 2011 at 02:58 | Report abuse |
  16. Matt Arnold Morgan

    I was diagnosed with ulcerative colitis 10 years ago. Since then I've found that I can't tolerate any OTC pain reliever as it messes with my gut. I've beaten colitis with diet changes and steered clear of western med – thankfully. But that's not the news I actually want to share. The news is that I don't miss the drugs at all. It's amazing what an ice pack can do, or a warm bath with Epsom salts. Without drugs to turn to you get more in tune with your body over time. You stretch, skip that 3rd glass of wine, etc. etc. It's the way to go brothers.... I'm not joshing you. They're not worth it AND YOU DON'T NEED THEM!

    January 13, 2011 at 23:55 | Report abuse | Reply
    • Codifex Maximus

      I agree with you that people take pain medicine unnecessarily. Personally, I avoid any kind of medicine unless I have absolutely no choice. Sometimes the pain is too harsh. Take for instance a toothache. You'll be slamming pain medicine and ambesol. I guarantee it. Busted ribs? Oh boy. It's nice to know that we are now being properly warned about these "safe" medications.

      January 14, 2011 at 00:34 | Report abuse |
  17. Richard Larson

    This is an interesting situation for me. After I experienced a severe fracture of my leg, I was put on a regimen of pain and inflammation medications for daily use that eventually led to approximately 2500mg of Motrin daily. This continued until my body rebelled and I insisted on a change in how I was being medicated. I had become so sensitive to aspirin that I couldn't even take the standard blood thinning dose without almost immediate physiological distress. For the past 15 years, I have been taking 30mg of Indomethacin daily. The scrip is for 90 mg per day, but I opt to put up with a certain amount of pain . When I need extra protection, I take 500mg of Tylenol. I have never experienced the kind of problems I had with the Motrin.

    What I cannot understand is the apparent certainty that this proclamation is being made. One wonders who did this so-called research and who paid for it. This whole episode smacks of a pharmaceutical company looking for ways to sell a new product and the FDA is falling right in line.

    January 14, 2011 at 00:52 | Report abuse | Reply
    • Chris

      Richard, 500mg of Tylenol even daily is not the problem, when you multiply that by 20 tablets rather it is all at once or throughout the day, you have now elevated your Tylenol level high enough that without treatment you can die a slow painful death because you caused enough liver damage. I work in a hospital and I have seen this often. Many people are not aware of this, especially those who are now abusing opiates that contain acetaminophen. Again the warning will not stop suicide attempts and drug abuse but it is a start to educate those who are not aware and hopefully will make good decisions to protect them self. You don't have to pay research to support the reality that is known in the medical field already.

      January 14, 2011 at 02:00 | Report abuse |
    • Ben Franklin

      I tried Indomethacin – totally disabled my sense of balance – constant vertigo, inability to walk straight, etc.

      January 14, 2011 at 03:00 | Report abuse |
  18. Chris

    So glad to see this happening. I see so many Tylenol overdoses that sometime are not intentionally during a suicide attempt because so many people are not aware of the risk of taking too much medication with Acetaminophen. People with opiate addictions are also not aware of the risk of acetaminophen that is found in common pain medications. I know this will not stop people from abusing medication but the fact that the FDA is now trying to educate the public about this is a step in the right direction. If I was not in the mental health field I myself would most likely not have know the risk and harms of taking too much Tylenol.

    January 14, 2011 at 01:54 | Report abuse | Reply
  19. Nurse John

    This is long overdue. I cannot tell you how many times someone has walked into my ER with with a heavy cold, flu symptoms or some other complaint and rattled off a list of drugs they are taking...all at the same time..... all containing acetaminophen... cooking their livers without knowing it....people whose life style includes regular alcohol consumption should avoid it as well...

    January 14, 2011 at 02:06 | Report abuse | Reply
  20. willie

    I can't believe that junk is still on the market. Tylenol is extremely dangerous, it kills people all the time. Bad for your liver. Just another example of how doctors have become little more than drug pushers. Since I became ill 20 years ago, 7 of the drugs that were prescribed to me have been taken off the market because they kill people. Worse yet is these drugs were only prescribed to me because I have an incredibly rare illness, they weren't intended for my disease, the doctors simply thought they "might" help. I'm lucky to be alive.

    January 14, 2011 at 02:20 | Report abuse | Reply
  21. Blame

    Clearly the fault of Sarah Palin.

    January 14, 2011 at 03:51 | Report abuse | Reply
  22. arch

    It is about time! This drug has some very nasty side effects if not taken correctly.The article needed to mention that when taking drugs with aceta included, to drink a lot of water. This helps flush your system and helps prevent poisoning. Acetaminophen poisoning happens all the time. We just don't hear too much about it. A good example of abuse of aceta is the TV show House. He's popping Vicoden all day long. We get the idea that he is taking about 4 or more tabs each time,(2 tabs every 3 to 4 hrs is normal dose). What he takes amounts to 20mg of Oxy,(4 tabs, unless he has the 10mg tabs, which would be 40mg), the rest in the drug is acetaminophen, which could be 1300-2000mg or more, depending on the amount, range of 325 to 750mg). He would be better off getting a script for Oxycontin only, (10,20,40,60,80 or more mg per pill), which doesn't contain acetaminophen. In real life his liver would be in bad shape as would his kidneys. The max amount of 4g,(4000mg) per 24hr period is, in my opinion, still too much. It isn't that good of a pain reliever and if you can get your drugs without the aceta in it you are better off. The FDA works in strange ways. This is an issue that has been around for many years and just now they are starting to do something about it. The big problem is taking the crap for long periods of time on a regular schedule. Ibuprofen,(Nsaid) has it's problem also. Again taking these drugs for short periods of time and taking them correctly, normally all is well. Tell your doctor,(if you need pain meds like oxy or ultrcet...) that you want the drug without the acetaminophen. They are on the market. While taking these meds if you feel the need for a little extra pain relieve, then you can take a couple aspirins(if they don't bother your stomach) or a couple acetaminophens or IBF. Remember, always drink a lot of water when taking meds, especially narcotics. Narcotics bind one and create very bad constipation. Taking softeners, etc. doesn't do much good. It is drinking A LOT of water that makes the bowels work and keep you happy!

    January 14, 2011 at 05:22 | Report abuse | Reply
  23. bisnono

    I suppose we can expect that the reduction in the per-pill dosage will not equal a reduction in the cost of a box of Tylenol.

    How typical. I can't WAIT to pay the same for less pain relief. What a rip-off!

    January 14, 2011 at 07:17 | Report abuse | Reply
  24. Richard

    Take it from someone who spent 1 week in ICU and another week recovering from vomiting PINTS AND PINTS of blood from ulcers caused by the Tylenol in a pain reliever. I've had over 9 surgeries and my Dr. prescribed 10-750 Hydrocodone and I never exceeded daily use. Well I woke up one night throwing up lots of blood, was rushed to the ER and tubes and everything jammed down my throat and my liver enzymes came back in the THOUSANDS I forget what the normal number is but it's 60 or 80 I THINK I'M NO DR. They said it was from the Tylenol in the meds and many don't realize this but diet pills also have Willow Bark in it which is an Aspirin Sub. which the Dr's also said contributed to my ulcers/liver enzymes. Needless to say I was minutes away from a liver transplant if my enzymes weren't slowly on the decline. I have never touched another Tylenol product and never will. I've never been close to death before and a man in his 30's who trusts his Dr's. prescription should have to even ponder a new liver or DEATH. I had to get the surgeries from serving my community in a State Law Enforcement capacity and now can't even return to work due to the pain from the surgeries.

    January 14, 2011 at 07:46 | Report abuse | Reply
  25. Terry

    So, J&J will put 100/250mg Tylenol tablets in a bottle, charge the current rate for a bottle with 50/500mg tablets, and all will be well.

    January 14, 2011 at 07:52 | Report abuse | Reply
  26. Guest

    Any individual who has taken Tylenol and read the warnings, and asks for and reads the info and warnings on their prescriptions, will see the warnings/info on meds containing acetaminophen. I've known about this for years because I choose not to be stupid about what I am ingesting so I read what comes with my drugs. Acetaminophen itself is not the root of the problem, we are. Too much of anything is dangerous. The real crazy part about this is we have been told for years how much of this is dangerous; most things don't. People need to grow up and realize they are the problem, not the thing they took too much of. Those with legitimate disabilities that prevent them from being able to read and/or grasp the information about their meds (which is readily available) are the only individuals who should ever be exempted from the personal accountability for this. It never ceases to amaze me how incredibly careless, irresponsible and unaccountable people choose to be. Why is it the government's responsibility to go above and beyond to protect us from ourselves when we choose to be lazy, ignorant and irresponsible? People want government out of everything else, but how dare the government not do more to allow us to be careless about this?

    January 14, 2011 at 08:00 | Report abuse | Reply
  27. JR

    There is not a drug on the planet that doesn't have a side effect. Most people who use OTC or prescription drugs do not read the fine print..or if they do, they don't think that 'it' will happen to them. This, to the point where people think that if they can get it in some form OTC, it's 'harmless'. Ergo, if the narc has acetaminophin or ibuprofen in it, that part isn't problematic, right?

    Wrong. There's been enough damage to people using these meds willy nilly without learning about what they are ingesting to warrant this. These regulations end up happening because they have to focus on the lowest common denominator. The person with absolutely NO education or interest in becoming educated. People who aren't picky about the rules described, every four hours? Uh, it's been two, I'm taking another one...and then he ends up overdosing himself and doesn't know it because he didn't read the label.

    So they create a buffer zone of safety so that even if Joe on the Street ingests more, he hopefully doesn't accidentally kill himself or end up on the liver transplant list. And that's what it comes down to.

    It's not about money, it's about keeping people from hurting themselves. This isn't brain surgery, but the seeming lack of interest to learn about this stuff by the general public and the subsequent injuries they inflict upon themselves is the reason for it. It doesn't take everyone being uninterested, just enough people have to hurt themselves in order to trigger this response by the FDA.

    January 14, 2011 at 08:07 | Report abuse | Reply
  28. PimmyZ

    This is just more nanny-State, molly coddling HorseShyt from the Federal Govt...which btw needs a huge trim. Too many stupid employees, agencies, mismanagement etc.

    January 14, 2011 at 08:35 | Report abuse | Reply
  29. jb582

    Combining narcotics with acetaminophen can also be seen as a way to deter abuse of the drug.

    January 14, 2011 at 08:45 | Report abuse | Reply
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  30. drug man

    I love how every so called expert comes out and spews out their knowledge on this subject as if we really care who you are (yes, i'm talking to you "LastToTouchYou" who felt it necessary to belittle a pharmacy student because he/she had an opinion on the subject, then stroke his ego by posting his credentials all over the board. If you have to say you're intelligent or show people your credentials to 'prove it,' you probably are not as intelligent as you believe. To that pharmacy student...thanks for your opinion and have fun with pharmacy school!

    January 14, 2011 at 09:22 | Report abuse | Reply
  31. Suzi

    Does anyone else remember many years ago a warning being put out about liver damage and aceta I do. I have been very careful with aceta since that time. People should always research by at least speaking with a pharmacist the meds they are taking. Ladies by taking too much aceta you can cause your monthly to be prolonged, which can lead to anemia. Just something else to think about.

    January 14, 2011 at 10:04 | Report abuse | Reply
  32. TD

    There are a few drugs that contain hydrocodone and acetominophen. A common one is Vicoden. It contains 5mg hydrocodone and 500mg acetominophen. Lortab is another one with the higher doses of acetoninophen.
    The only one with lower is Norco which is 5mg hydrocodone and guess how many of aceto...exactly 325! They have the patents to that dosage.
    I wonder who the makers of Norco are giving their money too.......

    January 14, 2011 at 19:38 | Report abuse | Reply
    • TD


      How come no reduction in regular Tylenol? They go above 325mg. Oh, because of the labeling? How about just putting one of those bright orange pharmacy stickers on the vicoden bottles?

      January 14, 2011 at 19:42 | Report abuse |
  33. CPhT

    All I know is that at my hospital, we go through several vials of Acetadote every month. Since I don't live in a major city like L.A., Chicago or New York, I can only assume the rates in larger populaces are proportionately higher. "Take as directed" is life-saving advice–no matter the medication.

    January 15, 2011 at 11:34 | Report abuse | Reply
  34. Drug-gulping cry-babies

    There are obviously those who need pain-killers for serious or chronic pain. But some people reach for pain-killers at the least little discomforture. The FDA is obviously right in doing what they did and the next thing the should do is either BAN or heavily regulate the multi-billion $ supplement and homeopathy market which is NO better than the snake-oil marketing in the late 1800's. Homeopathy uses such low doses of "medicinals" that it is probably a joke, but some supplements may be dangerous. Most are just overpriced and useless. Designed to be sold to the same people who thought vaccinations caused autism, that the stars determine their fortunes and who see UFO's every day.

    January 15, 2011 at 12:18 | Report abuse | Reply
  35. fridawrites

    For those saying it's the government interfering, the FDA required the drug manufacturers to put acetaminophin in hydrocodone in the first place *to cause* liver damage so that people would have a disincentive to get high. Then last year the FDA tried to remove hydrocodone from the shelves because of the dangers of combining it with hydrocodone–see other CNN news stories. The FDA is nothing if not contradictory. Personally as someone with intractable pain so bad it sometimes leaves me screaming (and I'm only on 325), I'd rather the acet. be out–that way I could take different anti-inflammatories without further increasing my liver counts.

    January 15, 2011 at 13:29 | Report abuse | Reply
  36. sandi.butt63

    Since I never got 2 finish my comment, here it is-My wain point is that the medical profession really do not care anymore. It is not so much their fault, as now days most of them cannot afford 2 B in private practice-thanks 2 the Feds! So they R in groups, such as huge clinics like the Mayo Clinic. These Clinics push the drs 2 see patients so quickiy, get them out the door once they pay, the dr has no real idea what he or she just saw! So 9 out of 10 pts leave with no clue what they have been given! I, too, am one who reads ALL the information provided by the pharmacy or other info. but the average pt does not understand what they have read. I have been in the field about 22 yrs, that is different. But if the government would get OUT of our personal lives in so many ways and concentrate on those who see multiple drs each month just 2 get pills 2 sell, it would help those of us who RIGHT NOW R BEING DISCRIMINATED AGAINST EVEN THOUGH WE R SUFFERING DAILY BECAUSE OF THEM, MAYBE WE WOULD HAVE A CHANCE 2 GET REAL HELP-NOT TYLENOL! I 4 one am sick of having 2 ever take another pill the rest of my life, however, thanks 2 sone of the things I have HAD 2 TAKE, certain bodily functions no longer function-my adrenal system, my pancreas, etc. THANKS DRUG COMPANIES!

    January 15, 2011 at 23:47 | Report abuse | Reply
  37. carl

    You know people just think Acetaminophen is a very safe drug and it is if you follow the labeling, but look at the labeling on the packaging sometime, you need a freaking magnifying glass just read it. What they need to do is make the product to read as follows in bold print. {Warning this product contains Acetaminophen do not take more then 4000mg in 24hrs or 1000mg at one time.} All people need to know about the dangers of Acetaminophen not just the ones that read the News. There is so many OTC drugs with Acetaminophen in it people just don't know how much they are taking to it is too late and they end up needing a Liver transplant or they die.

    January 16, 2011 at 05:09 | Report abuse | Reply
  38. AbrahamP

    New restrictions on painkilling medicines are due to be implemented. The Food and Drug Administration announced this ruling on Thursday. Narcotic painkillers may have a new limit - however not on the narcotics. Instead, the common painkiller acetaminophen can be limited. This limit is intended to help limit the number of possible overdoses from acetaminophen.

    January 20, 2011 at 00:50 | Report abuse | Reply
  39. J. Brown

    Good to see this is finally being noticed. I am 30 & have liver damage due to a high strength doseage of tylenol that is a prescription.

    January 26, 2011 at 13:11 | Report abuse | Reply
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