Aspirin/Butalbital/Caffeine/Codeine

Generic Name: Aspirin/Butalbital/Caffeine/Codeine (AS-pir-in/bue-TAL-bi-tal/KAF-een/KOE-deen)Brand Name: Examples include Ascomp-Codeine and Fiorinal with Codeine

Aspirin/Butalbital/Caffeine/Codeine is used for:

Treating tension headaches. It may also be used for other conditions as determined by your doctor.

How these medicines work is not completely understood. Aspirin reduces pain and inflammation. Caffeine may work by constricting blood vessels that may cause headaches. Butalbital has a depressant effect that reduces anxiety and causes relaxation. Codeine works in the central nervous system to decrease pain.

Do NOT use Aspirin/Butalbital/Caffeine/Codeine if:

  • you are allergic to nonsteroidal anti-inflammatory drugs (NSAIDs), any ingredient in Aspirin/Butalbital/Caffeine/Codeine , or any other codeine- or morphine-related medicine (eg, oxycodone).
  • you have von Willebrand disease, the blood disease porphyria, severe stomach or intestinal problems (eg, peptic ulcer, pseudomembranous colitis), blood clotting problems (eg, hemophilia), severe bleeding, severe liver damage, or severe low levels of vitamin K
  • you are taking sodium oxybate (GHB)
  • you are a child or teenager that has the flu, chickenpox, or joint problems

Contact your doctor or health care provider right away if any of these apply to you.

Before using Aspirin/Butalbital/Caffeine/Codeine :

Some medical conditions may interact with Aspirin/Butalbital/Caffeine/Codeine . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have asthma, stomach or intestinal problems (eg, inflammatory bowel disease), liver problems, the flu, nasal polyps, kidney problems, lung or respiratory tract disease, an enlarged prostate, severe heart disease, difficulty urinating, chickenpox, underactive thyroid, or vitamin K deficiency
  • if you are in very poor health or have a history of stroke, anxiety, substance abuse or dependence, depression, or suicidal thoughts or behaviors
  • if you have had head trauma, growths in the brain, or stomach or intestinal surgery

Some MEDICINES MAY INTERACT with Aspirin/Butalbital/Caffeine/Codeine . Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Anticoagulants (eg warfarin), celecoxib, clopidogrel, heparin, or NSAIDs (eg, ibuprofen) because the risk of serious side effects, such as stomach ulcers and bleeding, may be increased
  • Benzodiazepines (eg, chlordiazepoxide), cimetidine, HIV protease inhibitors (eg, ritonavir), monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), narcotic analgesics (eg, morphine), sleeping medicines (eg, temazepam), or sodium oxybate (GHB) because they may increase the risk of Aspirin/Butalbital/Caffeine/Codeine 's side effects
  • Naltrexone because it may decrease Aspirin/Butalbital/Caffeine/Codeine 's effectiveness
  • Carbonic anhydrase inhibitors (eg, acetazolamide), insulin, meglitinides (eg, repaglinide), methotrexate, quinolone antibiotics (eg, ciprofloxacin), or valproic acid because the risk of their side effects may be increased by Aspirin/Butalbital/Caffeine/Codeine
  • Angiotensin-converting enzyme (ACE) inhibitors (eg, lisinopril), antipsychotics (eg, clozapine), beta-blockers (eg, atenolol), corticosteroids (eg, prednisone), doxycycline, estrogens (eg, estradiol), metronidazole, oral contraceptives (eg, norethindrone/ethinyl estradiol), probenecid, quinidine, sulfinpyrazone, theophylline, or tricyclic antidepressants (eg, amitriptyline) because their effectiveness may be decreased by Aspirin/Butalbital/Caffeine/Codeine

This may not be a complete list of all interactions that may occur. Ask your health care provider if Aspirin/Butalbital/Caffeine/Codeine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Aspirin/Butalbital/Caffeine/Codeine :

Use Aspirin/Butalbital/Caffeine/Codeine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take Aspirin/Butalbital/Caffeine/Codeine by mouth. It may be taken with food if it upsets your stomach. Taking it with food may not lower the risk of stomach or bowel problems (eg, bleeding, ulcers). Talk with your doctor or pharmacist if you have persistent stomach upset.
  • Do not take Aspirin/Butalbital/Caffeine/Codeine if it has a strong vinegar-like smell, or if any vinegar smell remains after leaving the bottle open for 10 minutes.
  • If you miss a dose of Aspirin/Butalbital/Caffeine/Codeine and you are taking it regularly, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Aspirin/Butalbital/Caffeine/Codeine .

Important safety information:

  • Aspirin/Butalbital/Caffeine/Codeine may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Aspirin/Butalbital/Caffeine/Codeine with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Aspirin/Butalbital/Caffeine/Codeine ; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Serious stomach ulcers or bleeding can occur with the use of Aspirin/Butalbital/Caffeine/Codeine . Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking Aspirin/Butalbital/Caffeine/Codeine with food will NOT reduce the risk of these effects. Contact your doctor or emergency room at once if you develop severe stomach or back pain; black, tarry stools; vomit that looks like blood or coffee grounds; or unusual weight gain or swelling.
  • Tell your doctor or dentist that you take Aspirin/Butalbital/Caffeine/Codeine before you receive any medical or dental care, emergency care, or surgery.
  • Aspirin/Butalbital/Caffeine/Codeine has aspirin in it. Before you start any new medicine, check the label to see if it has aspirin in it too. If it does or if you are not sure, check with your doctor or pharmacist.
  • Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor. Taking more than the recommended dose or taking Aspirin/Butalbital/Caffeine/Codeine for longer than prescribed may be habit-forming.
  • Aspirin has been linked to a serious illness called Reye syndrome. Do not give Aspirin/Butalbital/Caffeine/Codeine to a child or teenager who has the flu, chickenpox, or a viral infection. Contact your doctor with any questions or concerns.
  • Hormonal birth control (eg, birth control pills) may not work as well while you are using Aspirin/Butalbital/Caffeine/Codeine . To prevent pregnancy, use an extra form of birth control (eg, condoms).
  • Use Aspirin/Butalbital/Caffeine/Codeine with caution in the ELDERLY; they may be more sensitive to its effects.
  • Aspirin/Butalbital/Caffeine/Codeine should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Aspirin/Butalbital/Caffeine/Codeine while you are pregnant. Aspirin/Butalbital/Caffeine/Codeine is not recommended during the last 6 months (second and third trimesters) of pregnancy because it may cause harm to the fetus. Aspirin/Butalbital/Caffeine/Codeine is found in breast milk. If you are or will be breast-feeding while you use Aspirin/Butalbital/Caffeine/Codeine , check with your doctor. Discuss any possible risks to your baby.

When used for long periods of time or at high doses, Aspirin/Butalbital/Caffeine/Codeine may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Aspirin/Butalbital/Caffeine/Codeine stops working well. Do not take more than prescribed.

Some people who use Aspirin/Butalbital/Caffeine/Codeine for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. If you suddenly stop taking Aspirin/Butalbital/Caffeine/Codeine , you may experience WITHDRAWAL symptoms, including anxiety, dizziness, hallucinations, lightheadedness, muscle twitching, nausea, seizures, sleeplessness, trembling hands and fingers, vomiting, or weakness.

Possible side effects of Aspirin/Butalbital/Caffeine/Codeine :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; drowsiness; gas; indigestion; lightheadedness; nausea; stomach pain.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black or bloody stools; confusion; severe drowsiness; shallow breathing; unusual bruising or bleeding.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include confusion; constriction of pupils; fast or irregular heartbeat; loss of consciousness; nausea; ringing in the ears; sleeplessness; slow or shallow breathing; stomach pain; tremor; unusual drowsiness or dizziness; vomiting.

Proper storage of Aspirin/Butalbital/Caffeine/Codeine :

Store Aspirin/Butalbital/Caffeine/Codeine at room temperature, below 77 degrees F (25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Aspirin/Butalbital/Caffeine/Codeine out of the reach of children and away from pets.

General information:

  • If you have any questions about Aspirin/Butalbital/Caffeine/Codeine , please talk with your doctor, pharmacist, or other health care provider.
  • Aspirin/Butalbital/Caffeine/Codeine is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Aspirin/Butalbital/Caffeine/Codeine . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

  • Fiorinal with Codeine Prescribing Information (FDA)
  • Fiorinal with Codeine Detailed Consumer Information (PDR)
  • Fiorinal with Codeine Concise Consumer Information (Cerner Multum)