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Butalbital/aspirin/caffeine/codeine (By mouth)

Aspirin (AS-pir-in), Butalbital (bue-TAL-bi-tal), Caffeine (KAF-een), Codeine Phosphate (KOE-deen FOS-fate)

A combination product that relieves tension headaches. Aspirin is a nonsteroidal anti-inflammatory drug (NSAID). Butalbital is a barbiturate. Codeine is a narcotic pain reliever.

Brand Name(s):

Ascomp w/Codeine, Fiorinal w/Codeine

There may be other brand names for this medicine.

When This Medicine Should Not Be Used:

Do not use this medicine if you have had an allergic reaction to butalbital, aspirin, caffeine, or codeine. Do not use this medicine 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. This medicine is not meant for use in children. Serious breathing problems and deaths have occurred when children have been given medicine that contains codeine.

How to Use This Medicine:

Capsule

  • Take your medicine as 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.

If a dose is missed:

  • This medicine is taken only when needed, so there are no special instructions for a missed dose.

How to Store and Dispose of This Medicine:

  • Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
  • Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
  • Keep all medicine out of the reach of children. Never share your medicine with anyone.

Drugs and Foods to Avoid:

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

  • Make sure your doctor knows if you are using an MAO inhibitor (such as Eldepryl®, Marplan®, Nardil®, Parnate®), a steroid medicine (such as hydrocortisone, methylprednisolone, prednisolone, prednisone), insulin or diabetes medicine that you take by the mouth (such as glimepiride, glyburide, metformin, Actos®, Janumet®, Januvia®), or a blood thinner (such as warfarin, Coumadin®, Jantoven®). Tell your doctor if you are also using 6-mercaptopurine (Purinethol®), methotrexate (Trexall®), probenecid (Benemid®), sulfinpyrazone (Anturane®), or another NSAID pain or arthritis medicine (such as aspirin, diclofenac, ibuprofen, naproxen, Advil®, Aleve®, Celebrex®, Voltaren®).
  • Do not drink alcohol while you are using this medicine.
  • Tell your doctor if you drink alcohol or if you are using any medicine that makes you sleepy, such as allergy medicine or narcotic pain medicine.

Warnings While Using This Medicine:

  • Make sure your doctor knows if you are pregnant, or if you have kidney disease, liver disease, Addison disease, breathing problems (such as asthma or sleep apnea), enlarged prostate, painful urination or trouble urinating, underactive thyroid, or stomach problems. Tell your doctor if you have a history of head injury, or if you have been addicted 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. Avoid driving, using machines, or doing anything else that could be dangerous until you know how this medicine affects you.
  • If you think you or someone else may have taken too much of this medicine, get emergency help at once. Signs of an overdose include seizure; extreme sleepiness; passing out; trouble breathing; uneven, fast, slow, or shallow breathing; nausea; vomiting; confusion; or pinpoint pupils of the eyes.
  • 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.

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, or 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
  • 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, nausea, vomiting, 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


Last Updated: 4/4/2014
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