Acetaminophen, aspirin, and caffeine

Name: Acetaminophen, aspirin, and caffeine

What is acetaminophen, aspirin, and caffeine?

Acetaminophen is a pain reliever and a fever reducer.

Aspirin is in a group of drugs called salicylates (sa-LIS-il-ates). It works by reducing substances in the body that cause pain, fever, and inflammation.

Caffeine is a central nervous system stimulant. It relaxes muscle contractions in blood vessels to improve blood flow.

Acetaminophen, aspirin, and caffeine is a combination medicine used to treat pain caused by tension headaches, migraine headaches, muscle aches, menstrual cramps, arthritis, toothaches, the common cold, or nasal congestion.

Do not use aspirin for heart or blood vessel conditions unless your doctor tells you to.

Acetaminophen, aspirin, and caffeine may also be used for purposes not listed in this medication guide.

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

Do not give this medication to a child or teenager with a fever, flu symptoms, or chicken pox. Aspirin can cause Reye's syndrome, a serious and sometimes fatal condition in children.

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Call your doctor at once if you have nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of your skin or eyes).

Aspirin may cause stomach or intestinal bleeding, which can be fatal. Call your doctor at once if you have symptoms such as bloody or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

In rare cases, acetaminophen may cause a severe skin reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

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

Do not give this medication to a child or teenager with a fever, flu symptoms, or chicken pox. Aspirin can cause Reye's syndrome, a serious and sometimes fatal condition in children.

You should not use this medicine if you are allergic to acetaminophen (Tylenol), aspirin, caffeine, or any NSAIDs (Advil, Motrin, Aleve, Orudis, Indocin, Lodine, Voltaren, Toradol, Mobic, Relafen, Feldene, and others).

Aspirin may cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are taking this medicine.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have other medical conditions, especially:

  • liver disease, cirrhosis, a history of alcoholism, or if you drink more than 3 alcoholic beverages per day;

  • asthma or seasonal allergies;

  • fever with a stiff neck;

  • stomach ulcer, stomach or intestinal bleeding, ulcerative colitis;

  • a bleeding or blood clotting disorder such as hemophilia;

  • kidney disease; or

  • if you use medicine to treat glaucoma or prevent blood clots.

If you take acetaminophen, aspirin, and caffeine to treat headache pain, seek medical attention if you have:

  • a headache so bad you have to lie down;

  • a headache that causes vomiting;

  • what feels like the worst headache you've ever had;

  • a headache that seems different from your usual headaches;

  • a headache every day;

  • a headache after coughing, bending, exercising, or head injury;

  • if you have never had migraines diagnosed by a doctor; or

  • if you are having your first headache after age 50.

Aspirin may be harmful to an unborn baby's heart, and may also reduce birth weight or have other dangerous effects. Tell your doctor if you are pregnant or plan to become pregnant while you are taking acetaminophen, aspirin, and caffeine.

Aspirin, acetaminophen, and caffeine can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

What happens if I miss a dose?

Since this medicine is used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of acetaminophen can damage your liver or cause death.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Overdose symptoms may also include ringing in your ears, headache, diarrhea, hallucinations, fast or slow heart rate, or seizure (convulsions).

For the Consumer

Applies to acetaminophen / aspirin / caffeine: oral packet, oral tablet

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Belly pain or heartburn.
  • Upset stomach.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Usual Adult Dose for Migraine

500 mg acetaminophen, 500 mg aspirin, and 130 mg of caffeine in combination per day as needed.

Maximum duration of migraine therapy: 48 hours

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