FDA Regulation and Changes on Acetaminophen Labels

Over the last 10 years the Food & Drug Administration has implemented several changes in the labeling of acetaminophen to help regulate accidental overdoses.

- 1998 - FDA finalized a regulation that required all OTC acetaminophen products to include the following alcohol warning: "ALCOHOL WARNING: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage."

- 2002 - FDA convened an Advisory Committee meeting to discuss unintentional liver toxicity related to the use of OTC acetaminophen. The Advisory Committee recommended a specific liver toxicity warning and distinctive labeling on OTC packages so that products containing acetaminophen could be more easily identified.

- early 2004 - FDA launched a public education campaign to help consumers use acetaminophen more safely.

- 2004 - FDA sent letters to every state board of pharmacy asking them to consider requiring labeling on the immediate container of Rx products containing acetaminophen that : (1) uses the term acetaminophen, not APAP, (2) instructs patients to avoid concurrent use of other acetaminophen containing drugs, (3) instructs patients not to exceed the maximum daily recommended acetaminophen dose, and (4) instructs petients to avoid drinking alcohol during prescription use. As of February 2008, no states had implemented regulations related to the request.

- 2006 - FDA issued proposed regulations for OTC labeling for acetaminophen containing products to require inclusion of new safety information and that the container adn outer carton identify acetaminophen when it is an ingredient. The final version of the regulation is currently under reveiw.

- 2009 - A meeting of The Drug Safety & Risk Management Advisory Committe recommended that all medicines containing acetaminophen must have it PROMINENTLY displayed on the container or outside carton if applicable. The product label contain new warnings that highlight the potential for liver toxicity and warn consumers against using more than the recommended dose of acetaminophen; using more than one product (over-the-counter or prescription) containing with acetaminophen, and taking acetaminophen with moderate amounts of alcohol.

It also advised that the product label contain a warning not to use acetaminophen with any other drug containing acetaminophen and to ask a doctor or pharmacist if persons are not sure whether a drug contains acetaminophen, a warning to ask a doctor before use if persons have liver disease, and a warning to ask a doctor or pharmacist before use if persons are taking the blood thinning drug warfarin. that the statement "see new warnings information" appears on the product's PDP for one year after the final rule is published.



Administration, U.S. Food and Drug. (2009, June 30). June 29-30, 2009: Joint Meeting of the Drug Safety and Risk Management Advisory Committee with the Anesthetic and Life Support Drugs Advisory Committee and the Nonprescription Drugs Advisory Committee: Meeting Announcement. Retrieved from http://www.fda.gov/advisorycommittees/calendar/ucm143083.htm
Administration, U.S. Food and Drug. (2009, May 1). Questions and Answers on Final Rule for Labeling Changes to Over-the-Counter Pain Relievers. Retrieved from http://www.fda.gov/Drugs/NewsEvents/ucm144068.htm

The Therapeutic Benefits of Acetaminophen.

Despite the harmful side effects of this popular drug there are considerable amounts of therapeutic benefits associated with acetaminophen.

• Unlike other popular painkillers, such as Bextra and Vioxx, it has never been recalled.
• It is also safe for patients with conditions such as heart disease, diabetes, and is a popular treatment for arthritis.
•  It is effective in reducing fever and pain but is not addictive.
• Acetaminophen is extremely affordable and accessible to many.
• When dosed correctly is safe for children and pregnant women.
• There are a vast number of formulations allowing flexibility in prescribing and methods of delivery.

Although raising consumer awareness is necessary and important, the dangers of possible overdose from acetaminophen should not be completely overshadowed by the advantages the drug offers. With the help of patient teaching and proper warning


LastInternational , E. (2005, August 29). Acetaminophen benefits from concerns surrounding safety . Retrieved from http://www.marketresearchworld.net/

Two Common Myths Associated with Acetaminophen

There are many myths that are associated with OTC drugs, but when considering those related to acetaminophen 2 common myths frequently come up. Below are 2 common myths and the information to nullify them:

1. Acetaminophen causes liver damage in alcoholics

• Previous information we have provided warns people who consume 3 or more alcoholic beverages a day to moderate and monitor their intake of acetaminophen as it may increase the chances of liver damage over a long period of time. There have been no studies that directly link occasional acetaminophen use and liver damage in alcoholics.   

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2. Acetaminophen use in children causes asthma

• Several studies have researched the development of asthma in children that consistently use acetaminophen. Although studies have linked heavy acetaminophen use in children to the increased risk of asthma development many doctors still recommend using acetaminophen for fevers over 101. Like many other OTC medications acetaminophen should be monitored.

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New myths related to acetaminophen use in adults and in children are surfacing daily. However, there are several studies and research projects varifying the validity of these myths. It is best to always practice safe acetaminophen administration including:

• ALWAYS use the recommended dose and dosage time when taking acetaminophen
• ALWAYS use the provided measuring tool for liquid forms
• ALWAYS consult a healthcare provider if you are taking other medications to assure it is safe to take acetaminophen in combination
• If you think you are suffering any of the side effects associated with acetaminophen overdose CONTACT YOUR HEALTHCARE PROVIDER IMMEDIATELY

Kuffer EK, Dart RC, Bogdan GM, Hill RE, Caper E, Darton L. Effect of maximal daily doses of acetaminophen on the liver of alcoholic patients. Arch Intern Med 2001; 161:2247-2252.
DeNoon, D. J. (2008, September 18). Baby Acetaminophen Tied to Asthma. Retrieved from http://www.rxlist.com/script/main/art.asp?articlekey=92849

Studies and Statistics Regarding Acetaminophen Overdoses

Several medical conditions associated with acetaminophen overdose have been the focus of many clinical studies. Theses studies have been conducted to gain a better understanding of the affects that acetaminophen has on the human body in larger than recommended doses. McLaughlin and his associates note that, "heavy use of analgesics, particularly over-the-counter (OTC) products, has long been associated with chronic renal failure, including acetaminophen." A 2002 study pointed out that, "most instances of hepatotoxicity due to paracetamol in the United Kingdom and Australia are the result of large overdoses of the drug taken with suicidal or parasuicidal intent. In contrast, serious hepatotoxicity at recommended or near-recommended doses for therapeutic purposes has been reported, mainly from the United States and in association with chronic alcohol use, leading to the widely held belief that chronic alcoholics are predisposed to paracetamol-related toxicity at relatively low doses." Paracetamol is more commonly known as acetaminophen in the United States.


Hypokalemia is also a recognized complication of acute acetaminophen overdose which may lead to cardiac arrhythmia's as well as fatigue and muscle weakness. Hypokalemia is defined as low potassium levels within the blood. Mild hypokalemia is often not associated with signs and symptoms. In 2005 the Southern Medical Journal reported that acetaminophen is the most common drug overdose in pregnancy. Acetaminophen has been demonstrated to cross the placenta and in toxic doses may harm the fetal and maternal hepatocytes (liver cells) and may cause fetal hepatic necrosis, abnormal liver cell death.


A study published in 2009 reported that acetaminophen was the number 1 cause of emergency department visits among children related to unintentional medication overdoses. Of the 6,028 visits, 289 were related to acetaminophen compared to the 211 visits due to opioid (i.e. codeine, morphine, hydrocodone) overdoses.





McLaughlin, J., Lipworth, L., Chow, W., &Blot, W. (1998, September). Analgesic use and chronic renal failure: a critical review of the epidemiologic literature. Kidney International, 54(3), 679-686. Retrieved September 8, 2009, from MEDLINE database.
Riordan, S., & Williams, R. (2002, April). Alcohol exposure and paracetamol-induced hepatotoxicity. Addiction Biology, 7(2), 191-206. Retrieved September 8, 2009, from MEDLINE database.
Waring, W., Stephen, A., Malkowska, A., & Robinson, O. (2008, March 28). Acute acetaminophen overdose is associated with dose-dependent hypokalaemia: a prospective study of 331 patients. Basic & Clinical Pharmacology & Toxicology, 102(3), 325-328. Retrieved September 8, 2009, from MEDLINE database.
Wilkes, J., Clark, L., & Herrera, J. (2005, November). Acetaminophen overdose in pregnancy. Southern Medical Journal, 98(11), 1118-1122. Retrieved September 8, 2009, from MEDLINE database.

Acetaminophen overdose happens more frequently than you think. Acetaminophen poisoning has become the most common cause of acute liver failure in the United States. Although many of those cases involve attempted suicides, almost 50% are the result of unintentional overdoses. Above is a table listing the various signs and symptoms associated with acetaminophen poisoning.

Here is a reminder of the important things to consider when administering or ingesting acetaminophen:

• Maximum dosage for adults per day is 4 grams or 4,000 milligrams.
• Maximum dosage for infants and children depends on their weight and dosage must be obtained from their practicing pediatrician.
• If you are taking a combination of medications consult your healthcare provider to inquire if it is safe to take acetaminophen products along with your other medications.
• Always use the provided measuring tool for liquid acetaminophen.
• Always follow the dosing guidelines provided on the medication bottle.

Below is a story of how an acetaminophen overdose affected a family and the lessons to be learned when taking the common OTC pain reliever:



DiJoseph, S (2006). Test for Liver Damage from Acetaminophen Poisioning Found To Be 100% Accurate, (www.newsinferno.com), Retrieved from link: http://www.newsinferno.com/archives/1133 http://video.aol.com/video-detail/danger-in-your-medicine-cabinet/4232588662

Self-Medicating is Easy

If you have ever suffered from a headache or other ailment you've more than likely reached into your medicine cabinet, grabbed a bottle of Tylenol and have taken 2-3 tablets. Consumers self-medicate daily and it has been made easier to do with over-the-counter (OTC) drugs such as Tylenol, otherwise known as acetaminophen. Tylenol, like other similar pain relievers/fever reducers, can be purchased without a prescription or doctor's appointment and has been labeled a "wonder" drug.Acetaminophen has been packaged and sold as an OTC antipyretic, which acts as a fever reducer, and an analgesic or pain reliever since 1960. It is in over 600 OTC and prescription drugs including cough and cold medications, sleep aids, Vicodin, Percocet and several others. Acetaminophen is a wonderful drug for relieving pain and reducing fever when taken properly, but thousands of consumers have not been properly educated in correct and safe self-medication.The dangers of acetaminophen are becoming more apparent because of our heavily medicated population and the wide variety of ways in which it can be used for treatment. Here are the important "How To's" when taking acetaminophen:

• Take the recommeded dose listed on the medication bottle
• If you consume 3 or more alcohol beverages a day limit your use of acetaminophen if you are taking the drug over several days.
• Be careful when taking with other medications because they may also contain acetaminophen. If unsure consult your healthcare provider.
• Max dosage is 4 grams or 4,000 milligrams a day.
• There are different concentrations for infants, children, and adults
• There are different forms of acetaminophen including pill, suppository, and liquid which all contain different concentration levels.
• Always use the provided tool for measuring.

Hardman , JG (January, 22 2004). safety concerns associated with over-the-counter drug products containing analgesic/antipyretic active ingredients for internal use. food and drug administration science background, 43(9), Retrieved from http://www.fda.gov/drugs/drugsafty/informationbydrugclass/ucm165107.htm