For the Media: The Active Ingredients
                            in OTC Pain Relievers

Whether it’s to treat a headache, muscle and joint pain, a cold or the flu, allergies, sinus pressure, menstrual cramps or a number of other common problems, drug stores, supermarkets, and other stores offer hundreds of different over-the-counter pain relievers for these everyday ailments.

But despite this large selection, what most consumers don’t realize is that the vast majority of OTC pain relievers and cough/cold and allergy products now on the market actually contain a very small number of active ingredients. In the case of pain medicines containing a single ingredient, almost every product sold today uses only one of four active ingredients: acetaminophen, aspirin, ibuprofen, and naproxen sodium.

These same four active ingredients are also found in combination cough/cold and allergy/sinus products and in many prescription pain medicines. What this means is that unless consumers know the active ingredient or ingredients in the OTC pain relievers they are taking, they may unwittingly combine two medicines containing the same active ingredient (thus doubling the dose) or may put themselves at risk for serious problems if these products are used by people who are taking other medicines to treat specific medical conditions.

Of equal concern to the National Consumers League (NCL), the Food and Drug Administration (FDA), and the public health community is the pervasive view that OTC drugs are not “real” medicine and therefore, it is permissible to take more than what is directed on the label. According to recent surveys commissioned by the National Consumers League and the National Council on Patient Information and Education (NCPIE), almost half of Americans readily admit exceeding the recommended dose of OTC pain relievers, believing that this step will increase the effectiveness of these medicines.

To address these common misperceptions, NCL has joined forces with FDA to give consumers the essential facts about the four most commonly used active ingredients in OTC pain relievers and cough/cold medicines so they will appreciate the fact that they are powerful medicines and must be used correctly. The following summarizes what these ingredients are and when precautions are needed.

Acetaminophen

The most widely used pain reliever in the United States, acetaminophen is used as a single ingredient OTC pain reliever, in combination with other active ingredients to make common multi-symptom OTC medicines, and as an ingredient in many prescription pain medicines. Acetaminophen works by elevating the body’s overall pain threshold, and it lowers fever by helping the body eliminate excess heat. 

When taken as directed, acetaminophen is effective and does not cause the stomach irritation often associated with non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin, naproxen sodium, and ibuprofen. For this reason, doctors often recommend acetaminophen for people over 50,[1] children, and those with such conditions as asthma, kidney disease, osteoarthritis, hypertension, or pregnancy.[2] Compared with NSAIDs, acetaminophen has fewer drug interaction risks.[3] Consumers who consume three or more alcoholic drinks every day should ask their doctor whether they should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage.

Because so many OTC and prescription medicines contain acetaminophen, it is important for consumers to take only one medicine with acetaminophen at a time and to follow the directions for use carefully.

Aspirin

Classified as a non-steroidal anti-inflammatory drug (NSAID), aspirin is one of the oldest OTC pain relievers on the market and is either used alone or as an active ingredient in many OTC medications. Aspirin works by slowing down the body’s production of a pain-causing substance called “prostaglandin.”[4] When used under the advisement of a physician, aspirin is also the only over-the-counter pain reliever approved by FDA for the prevention of recurrent cardiovascular problems and recurrent stroke in people who have unstable angina, or who have suffered a heart attack or a transient ischemic attack (known as a “TIA” or “mini-stroke”).

As with other OTC pain relievers, aspirin is safe when taken as directed. However, taking more than the recommended dose or taking aspirin on an ongoing basis can cause gastrointestinal bleeding. Moreover, aspirin may interfere with a number of common OTC and prescription drugs. Consumers should ask a doctor or pharmacist before use if they are taking a prescription drug for: anticoagulation (blood thinning), gout, diabetes or arthritis. In addition, children and teenagers should not take aspirin for chicken pox or flu symptoms before a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with aspirin.

Ibuprofen

One of the most commonly used NSAIDs, ibuprofen is found in a variety of OTC and prescription medicines, both alone and in combination with other active ingredients, such as cold and flu products and allergy medications. Ibuprofen works by blocking the production of substances in the body that cause pain and inflammation. Therefore, it is an NSAID used to treat aches and pains including headache, muscle aches, the minor pain of arthritis, toothache, backache, the common cold, and menstrual cramps. Ibuprofen is used to reduce fever temporarily. 

When taken as directed, ibuprofen is an effective pain reliever, but this ingredient can cause gastrointestinal bleeding. People over age 65 should talk to their doctor before taking ibuprofen.

Naproxen Sodium

One of the newer NSAIDs on the market, naproxen sodium is used in OTC pain relievers and cough-cold medicines, as well as some prescription anti-inflammatory drugs. As with other NSAIDs, naproxen sodium works by blocking the production of the substances in the body that cause pain and inflammation.[5] It is an effective analgesic and is effective when taken as directed. However, people over age 65 should consult with their doctor before taking OTC pain relievers containing naproxen sodium.

Some Common Issues

While the active ingredients in OTC pain relievers have a number of differences in how they work, some important precautions apply across the board. These include:

Alcohol:

The labels on all OTC pain relievers state that people who drink three or more glasses of alcohol a day should talk to a doctor or pharmacist before taking any OTC pain medication.

Pregnancy:

If a woman is pregnant or breast-feeding, she is advised to ask a health care provider before taking any medication (OTC or prescription). It is especially important not to use aspirin, ibuprofen, or naproxen sodium during the last three months of pregnancy unless directed to do so by a doctor, because these medicines may cause problems in the unborn child, or complications during delivery.

Allergic Reactions

The potential for an allergic reaction exists with all OTC pain relievers. Allergic reactions related to aspirin, ibuprofen, and naproxen sodium may include hives, facial swelling, asthma (wheezing), or shock. People who have allergies or think they may be allergic should consult a doctor before using any OTC or prescription pain reliever.

Duration of Use 

Unless taken under a doctor’s care, the use of OTC pain relievers is intended to be temporary — up to ten days for pain and up to three days for a fever. If symptoms persist after this time period, it is important to consult with a physician.

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