Aspirin, butalbital, and caffeine is a combination medicine used to treat symptoms of tension (muscle contraction) headaches. This medicine is not for treating multiple headaches that come and go.

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

You should not use this medicine if you are allergic to aspirin, butalbital, or caffeine, or if you have:

• a bleeding or blood clotting disorder such as hemophilia, von Willebrand's disease, low platelets;
• severe vitamin K deficiency;
• severe liver disease;
• a severe allergic reaction (sneezing, runny or stuffy nose, wheezing) after taking aspirin or another NSAID (nonsteroidal anti-inflammatory drug) such as ibuprofen, celecoxib, diclofenac, indomethacin, meloxicam, naproxen, Advil, Motrin, Aleve, and others;
• a stomach ulcer; or
• porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system).

Not approved for use by anyone younger than 18 years old. Using this medicine in a child or teenager with flu symptoms or chickenpox can cause a serious or fatal condition called Reye's syndrome.

Tell your doctor if you have ever had:

• liver or kidney disease;
• bleeding problems;
• a head injury or brain tumor;
• a stomach or intestinal disorder;
• underactive thyroid;
• allergies;
• an enlarged prostate or urination problems; or
• Addison's disease (an adrenal gland disorder).

Do not use this medicine during pregnancy unless your doctor tells you to. Using butalbital during pregnancy may cause withdrawal symptoms in the newborn. Using aspirin in the last 20 weeks can harm the unborn baby or cause pregnancy complications.

Do not breastfeed.

Use Fortabs (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Stop taking this medicine and seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Call your doctor at once if you have:

• bloody or tarry stools;
• coughing up blood or vomit that looks like coffee grounds; or
• any bleeding that will not stop.

Common side effects may include:

• drowsiness; or
• dizziness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Ask a doctor or pharmacist before using other medicines for pain, fever, swelling, or cold/flu symptoms. They may contain ingredients similar to aspirin (such as ibuprofen, ketoprofen, or naproxen).

Avoid drinking alcohol.