FAQs About Acetaminophen and Other Oral OTC Pain Relievers and Fever Reducers

OTC oral pain relievers and fever reducers (also referred to as ” internal analgesics,”) include acetaminophen and the nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin, ibuprofen, ketoprofen, and naproxen sodium.

Pain Relievers and Fever Reducers (Internal Analgesics)

What are internal analgesics?

Internal analgesics are a category of drugs that includes painkillers and fever reducers. Analgesics can be either prescription or over-the-counter (OTC). OTC internal analgesics include the following active ingredients: acetaminophen, aspirin, ibuprofen, ketoprofen, and naproxen sodium. Some analgesics also are grouped as nonsteroidal anti-inflammatory drugs or NSAIDs. OTC NSAIDs include aspirin, ibuprofen, ketoprofen, and naproxen sodium.

How do I know if an OTC pain reliever or fever reducer is right for me?

Before taking any OTC medication, consumers should read the OTC Drug Facts label, including the indications for use, the warnings, and the directions to determine if the product is right for them. The bottom line is always read and follow the label directions. If you have any questions, ask your doctor or pharmacist before taking the medicine.

Where can I go for more information about OTC pain relievers and fever reducers?

Health in Hand has information, tip sheets, and brochures for consumers on the safe use of medicines. Visit HealthinHand.org for more information. The makers of OTC pain relievers and fever reducers also have information about their products on their websites, or you can call them directly.

How much of a product is too much, and how long is too long to take an OTC pain reliever or fever reducer?

Consumers should use OTC pain relievers and fever reducers — and all medicines — according to the directions on the Drug Facts label, and ask their doctor or pharmacist if they have questions or concerns. OTC analgesics are not intended to be used for longer than directed on the label, unless a physician who is familiar with the patient’s medical history advises them to do so. Since OTC analgesic ingredients are common in many OTCs and prescription medications, it also is very important to pay close attention to active ingredients and to never take more than one medicine with the same active ingredient at the same time unless specifically told to do so by a doctor. Taking multiple medicines with the same active ingredient could put you at risk of overdose.

Acetaminophen

Is acetaminophen safe?

Yes, acetaminophen is very safe and effective when used as directed. It has been relied upon for generations by millions of consumers to relieve pain and reduce fever and is the most commonly used medicine in the United States. It is approved by the U.S. Food and Drug Administration (FDA), which has continuously reaffirmed the ingredient’s safety at recommended doses for people ages two years and older. As with any medicine, however, it has to be used according to the directions on the Drug Facts label. You should never use more or for longer than the label instructs. In addition, since different medicines may contain acetaminophen, it is vitally important to make sure you are not taking two medicines (OTC or prescription) that contain acetaminophen. Taking two acetaminophen-containing medicines at the same time or taking more than the recommended amount can lead to overdose and may cause liver damage.

What is acetaminophen used for?

Acetaminophen, which comes in both OTC and prescription medicines, is a temporary fever reducer and pain reliever, including pains associated with minor aches and pains due to headache, muscular aches, backache, minor arthritis pain, the common cold, toothache, and premenstrual and menstrual cramps. It is intended for short-term use only. Consumers are instructed to stop use and talk to a doctor if their pain gets worse or lasts for more than 10 days or if their fever worsens or lasts more than three days. More information on acetaminophen is available on KnowYourOTCs.org.

Which products contain acetaminophen and how do I recognize it?

Acetaminophen is a commonly used pain and fever reducer and is used in both prescription and OTC medicines. It also can be used in many combination products, like cough and cold, and flu remedies. OTC medicines that contain acetaminophen always list the ingredient on the OTC Drug Facts label in the active ingredient section. Acetaminophen will also always be highlighted or bolded on all Drug Facts labels to help consumers recognize when it is present in a product, and will be written on the front of the package. It is important to note that prescription medicines do not have Drug Facts labels and may abbreviate acetaminophen with "APAP" or "Acetam."

How are acetaminophen-containing OTCs labeled?

Acetaminophen-containing OTCs have a Drug Facts label that clearly lists the medication’s active ingredient, uses, and instructions not to use it with any other drugs containing acetaminophen or if you drink three or more alcoholic drinks per day. In addition, the labels include instructions regarding short-term use and list warning signs about when to contact a doctor. Pregnant or breastfeeding women are instructed to talk to a health professional before using any acetaminophen-containing medication and all products carry a poison prevention warning instructing parents to keep these medicines out of the reach of children.

Consumers should be aware that taking too much acetaminophen (overdose) can cause liver damage. Taking too much acetaminophen may involve taking more than the labeled dosage or taking more than one acetaminophen-containing medication at the same time. If you suspect you have overdosed on acetaminophen, contact a healthcare professional or contact poison control at 800.222.1222 immediately.

What should I do if I suspect I’ve taken too much acetaminophen?

Taking too much acetaminophen may cause an overdose and can lead to liver damage. If you suspect you have taken too much acetaminophen or have given too much acetaminophen to someone you offer care to, contact a healthcare provider or the nationwide poison control hotline immediately at 800.222.1222.

For information on how to use medications safely, visit KnowYourOTCs.org.

Has there been recent FDA action focused on acetaminophen?

In June 2009, FDA hosted a joint advisory committee meeting to discuss “the public health problem of liver injury related to the use of acetaminophen in both OTC and Rx products.” While noting the importance of the drug and its continued availability to consumers, as well as the very low risk of liver injury when used as directed, FDA decided to seek additional input in how to address the issue. According to FDA’s analysis, unintentional overdoses represent a very low portion of serious adverse events; the overwhelming majority of fatalities related to acetaminophen overdose (83 percent for Rx and 84 percent for OTCs) are intentional suicides.

An FDA working group put forward a number of risk-mitigation recommendations for the agency’s advisory committees to discuss. The industry supplied FDA with briefing materials in advance of the June 2009 meeting to offer a perspective on those recommendations as well as offer a plan to reduce unintentional overdoses from acetaminophen.

Both the medicines’ makers and FDA agree that adverse events associated with the proper, labeled use of acetaminophen-containing OTCs are very rare. The industry has since embarked on a multi-channel educational and research program to further reduce the risk of unintentional overdoses with acetaminophen. Learn more about the Acetaminophen Awareness Coalition and its safe-use tips at www.KnowYourDose.org.

Where can I go for more information about OTC acetaminophen?

The Acetaminophen Awareness Coalition, of which the Health in Hand Foundation is a founding member, has information, tip sheets, and brochures for consumers on the safe use of medicines, including acetaminophen. Visit KnowYourDose.org for more information. Many AAC members also have acetaminophen safe-use content on their websites, including the FDA, the National Council on Patient Information and Education, the National Community Pharmacists Association, and others.

NSAIDs

What are nonsteroidal anti-inflammatory drugs and what are they used for?

NSAIDs, as they often are called, are very effective analgesics, or painkillers. Part of the overall analgesic category, NSAID active ingredients in OTC medicines include aspirin, ibuprofen, ketoprofen, and naproxen sodium. They are used for the temporary relief of minor aches and pains and fever, and help reduce inflammation. Not all analgesics are NSAIDs. Acetaminophen is an analgesic but is not an NSAID.

Are OTC NSAIDs safe to use?

Yes. OTC NSAIDs are safe and effective when used according to the Drug Facts label. OTC NSAIDs have been approved by FDA and its advisory committees through a rigorous review process. FDA has stated that the available data supports the safety of OTC NSAIDs when used according to the Drug Facts label. The important thing for all consumers to remember is that OTC NSAIDs, like all medicines, should only be used according to the directions. Consumers should consult with a physician or other healthcare professional if they have any questions regarding use of OTC NSAIDs.

For more information on the safe use of NSAIDs, visit KnowYourOTCs.org.

What is the difference between prescription NSAIDs and over-the-counter NSAIDs?

OTC medicines are intended for use for short periods of time, while prescription NSAIDs can be for long-term or chronic use when directed by a physician. OTC NSAIDs are usually used at a lower dose than prescription NSAIDs and are intended for self-limiting conditions, and are not intended to be used for long durations. OTC medicines also differ from prescription drugs in their labeling. The OTC Drug Facts label contains all the information a consumer needs in order to select an appropriate OTC medicine, to use the medicine safely and effectively, and to decide when to consult a physician, if needed. Prescription drugs can only be used by patients under the care of a physician and prescription drugs do not usually have comprehensive labeling.

What are the risks of taking OTC NSAIDs?

OTC NSAIDs are safe and effective when used according to the label. FDA approved NSAIDs for over-the-counter use based on their wide margin of safety and ability to be used by consumers appropriately and safely according to the label, without the intervention of a physician. As with any medication, not following labeling directions may lead to serious health problems. Consumers must read the label and pay particular attention to the warning section and consult their doctor or pharmacist if they have any questions before taking any medication. Consumers should not take any product at a higher dose or for longer than indicated on the label, unless directed by a physician. It is also important not to take two products that contain the same active ingredient at the same time, unless directed by a doctor. The reason is simple: Taking more than one medication with the same active ingredient means that you might be taking too much of that active ingredient, which could put you at risk of serious health effects. Taking too much of an NSAID can cause stomach problems and other health effects.

Is it safe to take NSAIDs over an extended period of time to treat arthritis?

Many consumers use NSAIDs to alleviate the pain associated with arthritis. OTC NSAIDs should not be used longer than indicated on the Drug Facts label unless recommended by a doctor. Consumers should talk to their doctor about taking over-the-counter medications for anything that is not on the label, including taking products for a longer duration or at a higher dose. All NSAIDs tell consumers not to use for pain for longer than ten days.

What will happen if I take too much of an NSAID for too long?

Warning signs may vary in each individual and the Drugs Facts label provides signals to be alert to that may indicate a problem. It is very important to remember, however, that if you feel you have taken too much of a product or if you are experiencing an adverse event, you should contact your doctor immediately. All NSAIDs tell consumers to stop use and talk to a doctor if pain gets worse or last more than ten days or if fever worsens or lasts more than three days.

How are OTC NSAIDs labeled?

OTC NSAIDs have Drug Facts labels. Like all OTCs, NSAIDs have full directions for dosing, and list the ingredients the products contain and their purpose. NSAIDs also warn about drinking three or more alcoholic drinks per day and alert consumers to the potential for bleeding problems. Pregnant and nursing women are instructed to talk to a healthcare professional before using, and all products have a warning to keep them out of the reach of children. Aspirin-containing NSAIDs also caution parents not to use with children and teens for chicken pox or flu symptoms before a doctor is consulted about Reye’s syndrome.

If you have any concerns about how to use NSAIDs, contact a doctor, pharmacist, or other healthcare professional. If you believe you have taken too much of an NSAID, contact a healthcare professional or the nationwide poison control hotline at 800.222.1222 immediately.

Where can I go for more information on how to safely use NSAIDs?

Health in Hand has information, tip sheets, and brochures for consumers on the safe use of medicines. Visit HealthinHand.org for more information on aspirin, ibuprofen, ketoprofen, and naproxen sodium. The makers of OTC NSAIDs also have information about their products on their websites.