When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to butalbital, aspirin or other salicylates, arthritis medicine, or caffeine. Do not use this medicine if you have porphyria, stomach ulcers, or a bleeding disorder.

How to Use This Medicine:
Tablet, Capsule

• Your doctor will tell you how much medicine to use. Do not use more than directed. Do not increase your dose without your doctor's approval.
• This medicine may be taken with food or milk if it upsets your stomach.
• This medicine works best if you take it at the first sign of pain. Do not wait until the pain is severe.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how this medicine works. Tell your doctor if you are taking any of the following:
  
  • Blood thinner, such as warfarin
  • Insulin or oral diabetes medicine
  • Medicine that makes you sleepy, such as allergy medicine or narcotic pain medicine
  • Methotrexate or 6-mercaptopurine
  • NSAID pain or arthritis medicine, such as aspirin, diclofenac, ibuprofen, naproxen, celecoxib
  • Probenecid or sulfinpyrazone
  • Steroid medicine, such as dexamethasone, hydrocortisone, methylprednisolone, prednisone

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or you have asthma, other lung disease, or liver or kidney problems.
• Do not give this medicine to a child who has a fever or symptoms of an infection. This medicine contains aspirin. Aspirin can cause a life-threatening reaction called Reye syndrome in children.
• Do not drink alcohol while you are using this medicine. Alcohol combined with this medicine may cause life-threatening problems.
• This medicine may make you dizzy or drowsy. Do not drive or do anything that could be dangerous until you know how this medicine affects you.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• This medicine can be habit-forming. Do not use more than your prescribed dose. Call your doctor if you think your medicine is not working.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash
• Chest tightness, shortness of breath, or trouble breathing
• Fast, slow, or pounding heartbeat
• Fever, tiredness, itching, and red spots or bumps on your skin

If you notice these less serious side effects, talk with your doctor:

• Lightheadedness, dizziness, drowsiness
• Nausea, vomiting, constipation, gas

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088