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What is the most important information I should know about acetaminophen, aspirin, and caffeine?

If your symptoms do not improve, or if they get worse, stop taking acetaminophen, aspirin, and caffeine and contact your doctor.

Do not drink alcohol during treatment with acetaminophen, aspirin, and caffeine. Together, alcohol, acetaminophen, and aspirin can be damaging to the liver and stomach. If you drink more than three alcoholic beverages a day, talk to your doctor before taking acetaminophen, aspirin, and caffeine.

Read the labels on other prescription and over-the-counter medicines you are taking to determine the amount of acetaminophen, aspirin, or caffeine they contain. Do not take more than one product that contains acetaminophen or aspirin in the same day, unless otherwise directed by your doctor.

This product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing beverages, foods, and medications while taking this product. Too much caffeine may cause nervousness, irritability, sleeplessness, and a rapid heartbeat.

What is acetaminophen, aspirin, and caffeine?

Acetaminophen is a pain reliever and a fever reducer.

Aspirin is in a class of drugs called salicylates. It works by reducing substances in the body that cause pain and inflammation.

Caffeine is used in this product to increase the pain relieving effects of acetaminophen and aspirin.

Together, acetaminophen, aspirin, and caffeine are used to treat pain from conditions such as headache (including migraine), muscle aches, menstrual cramps, arthritis, backache, toothaches, colds and sinus infections.

Acetaminophen, aspirin, and caffeine may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking acetaminophen, aspirin, and caffeine?

Do not drink alcohol during treatment with acetaminophen, aspirin, and caffeine. Together, alcohol, acetaminophen, and aspirin can be damaging to the liver and stomach. If you drink more than three alcoholic beverages a day, talk to your doctor before taking acetaminophen, aspirin, and caffeine.

Before taking this medication, tell your doctor if you

• have an allergy to or have had problems after taking aspirin;

• have an allergy to or have had problems after taking a nonsteroidal anti-inflammatory drug (NSAID) such as ibuprofen (Motrin, Advil, others), naproxen (Aleve, Naprosyn, Anaprox, others), indomethacin (Indocin), ketoprofen (Orudis KT, Orudis, Oruvail), nabumetone (Relafen), oxaprozin (Daypro), and others;

• drink more than three alcoholic beverages a day;

• have never had migraines diagnosed by a doctor;

• have a headache that is different from or more severe than your usual migraines;

• have daily headaches;

• have a headache following or caused by a head injury, exertion, coughing, or bending;

• experienced your first headache after age 50;

• have an ulcer or bleeding in the stomach;

• have liver disease;
• have kidney disease;

• have a bleeding or blood clotting disorder (e.g., hemophilia);

• have high blood pressure;

• have gout;

• have asthma;

• have nasal polyps; or

• have anxiety problems or insomnia.

You may not be able to take acetaminophen, aspirin, and caffeine or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

It is not known whether acetaminophen, aspirin, and caffeine will be harmful to unborn baby. However, it is known that aspirin taken during pregnancy may affect an unborn baby's heart, reduce birth weight, and have other dangerous effects on the unborn baby. Do not take acetaminophen, aspirin, and caffeine without first talking to your doctor if you are pregnant or could become pregnant during treatment. Acetaminophen, aspirin, and caffeine may affect a nursing baby. Do not take this medicine without first talking to your doctor if you are breast-feeding a baby. Do not use acetaminophen, aspirin, and caffeine to treat a child or teenager who has a fever, flu symptoms, or chicken pox without first talking to the child's doctor. In children younger than 18 years of age, aspirin may increase the risk of Reye's syndrome, a rare but often fatal condition.

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