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, caffeine, or codeine. Do not use it if you have porphyria, bleeding or blood clotting problems (such as hemophilia, thrombocytopenia, vitamin K deficiency), severe liver damage, stomach ulcers, or a history of asthma with nasal polyps and rhinitis.

How to Use This Medicine:
Capsule

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• This medicine is not for long-term use.
• This medicine works best if you take it at the first sign of headache or pain.
• 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 and foods can affect how this medicine works. Tell your doctor if you are taking any of the following:
  
  • 6-mercaptopurine or methotrexate
  • Another NSAID pain or arthritis medicine, such as aspirin, diclofenac, ibuprofen, naproxen
  • Blood thinner medicine, such as warfarin
  • Insulin or oral diabetes medicine
  • MAO inhibitor (MAOI)
  • Probenecid or sulfinpyrazone
  • Steroid medicine, such as hydrocortisone, methylprednisolone, prednisolone, prednisone
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant, or if you have kidney or liver disease, Addison disease, breathing problems (such as asthma or sleep apnea), an enlarged prostate, painful urination or trouble urinating, an underactive thyroid, or stomach problems. Tell your doctor if you have a history of head injury or addiction to drugs or alcohol.
• Do not breastfeed while you are using this medicine, unless you have your doctor's permission to do so.
• 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.
• 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.
• Do not give this medicine to a child. Serious breathing problems and deaths have occurred when children have been given medicine that contains codeine.
• This medicine may cause constipation, especially with long-term use. Ask your doctor if you should use a laxative to prevent and treat constipation.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• 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
• Bloody or black, tarry stools
• Change in how much or how often you urinate, painful urination
• Extreme sleepiness, confusion
• Fast, slow, or pounding heartbeat
• Lightheadedness, dizziness, or fainting
• Nausea, vomiting
• Pinpoint pupils of the eyes
• Seizure
• Trouble breathing, shallow breathing
• Unusual bleeding, bruising, or weakness

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

• Constipation or stomach pain
• Mild drowsiness

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