Acetaminophen/ butalbital/ caffeine/ codeine

Generic Name: butalbital/acetaminophen/caffeine/codeine (bue-TAL-bi-tal/a-SEET-a-MIN-oh-fen/KAF-een/KOE-deen)
Brand Name: Fioricet with Codeine

Acetaminophen/butalbital/caffeine/codeine contains acetaminophen. Severe and sometimes fatal liver problems, including the need for liver transplant, have been reported with the use of acetaminophen. Most cases of these liver problems occurred in patients taking excessive doses of acetaminophen (more than 4,000 mg per day). Also, patients who developed these liver problems were often using more than 1 medicine that contained acetaminophen. Discuss any questions or concerns with your doctor.

Some children have had serious and sometimes fatal breathing problems when using acetaminophen/butalbital/caffeine/codeine after surgery to remove tonsils or adenoids. Acetaminophen/butalbital/caffeine/codeine should not be used in children to treat pain after surgery to remove tonsils or adenoids. Talk with your doctor for more information.


Acetaminophen/ butalbital/ caffeine/ codeine is used for:

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

Acetaminophen/butalbital/caffeine/codeine is a barbiturate, analgesic, stimulant, and narcotic combination. Acetaminophen and codeine work in the brain to relieve pain. Caffeine constricts blood vessels in the brain, which may help to relieve headache pain. Butalbital reduces anxiety and helps you to relax.

Do NOT use acetaminophen/ butalbital/ caffeine/ codeine if:

  • you are allergic to any ingredient in acetaminophen/butalbital/caffeine/codeine
  • you have the blood disease porphyria
  • you are taking quinidine or sodium oxybate (GHB)
  • the patient is a child being treated for pain after surgery to remove tonsils or adenoids

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

Slideshow: OTC Medication Use In Pregnancy: Wise or Worrisome?

Before using acetaminophen/ butalbital/ caffeine/ codeine:

Some medical conditions may interact with acetaminophen/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 are allergic to other narcotic medicines (eg, hydrocodone, morphine, oxycodone)
  • if you have severe drowsiness, or you have or recently had any head injury, increased pressure in the brain, growths in the brain (eg, tumors), or an infection of the brain or nervous system
  • if you have a history of liver problems (eg, hepatitis), kidney problems, heart problems (eg, cor pulmonale; fast, slow, or irregular heartbeat), low blood pressure, inflammation of the pancreas (pancreatitis), gallbladder problems, seizures, thyroid problems, adrenal gland problems (eg, Addison disease), curvature of the spine (scoliosis), lung or breathing problems (eg, asthma, chronic obstructive pulmonary disease [COPD]), stomach or bowel problems (eg, blockage, inflammation, paralysis), prostate problems (eg, an enlarged prostate), or trouble urinating
  • if you drink alcohol; have a history of alcohol or other substance abuse or dependence, mental or mood problems (eg, anxiety, depression), or suicidal thoughts or actions; or are going through withdrawal from alcohol or other substances
  • if you have recently had surgery (eg, stomach or bowel surgery) or are scheduled to have surgery
  • if you are in very poor health, are very overweight, are dehydrated or have low blood volume, or have stomach pain or constipation

Some MEDICINES MAY INTERACT with acetaminophen/butalbital/caffeine/codeine. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Anticoagulants (eg, warfarin) because the risk of bleeding may be increased
  • Medicines that may harm the liver (eg, certain medicines for HIV infection, ketoconazole, methotrexate) because the risk of liver side effects may be increased. Ask your doctor if you are unsure if any of your medicines might harm the liver
  • Chlordiazepoxide, isoniazid, linezolid, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), other narcotic pain medicines (eg, morphine), perampanel, quinolone antibiotics (eg, ciprofloxacin), sleep medicines (eg, zolpidem), sodium oxybate (GHB), or stiripentol because they may increase the risk of acetaminophen/butalbital/caffeine/codeine's side effects
  • Buprenorphine, naltrexone, or quinidine because they may decrease acetaminophen/butalbital/caffeine/codeine's effectiveness
  • Beta-blockers (eg, atenolol), clozapine, corticosteroids (eg, prednisone), doxycycline, estrogens (eg, certain hormonal birth control, estradiol), griseofulvin, metronidazole, tacrolimus, or teniposide because their effectiveness may be decreased by acetaminophen/butalbital/caffeine/codeine
  • Theophylline because its effectiveness may be decreased or the risk of its side effects may be increased by acetaminophen/butalbital/caffeine/codeine

This may not be a complete list of all interactions that may occur. Ask your health care provider if acetaminophen/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 acetaminophen/ butalbital/ caffeine/ codeine:

Use acetaminophen/butalbital/caffeine/codeine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take acetaminophen/butalbital/caffeine/codeine by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
  • Do not take more than 6 capsules in 24 hours.
  • If you have been taking acetaminophen/butalbital/caffeine/codeine regularly or for longer than a few weeks, do not suddenly stop taking it without checking with your doctor. Your doctor may need to gradually lower your dose.
  • If you miss a dose of acetaminophen/butalbital/caffeine/codeine and you still have a headache, follow your doctor's dosing instructions. Contact your doctor if you are unsure what to do if you miss a dose. Do not take acetaminophen/butalbital/caffeine/codeine more often than prescribed. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use acetaminophen/butalbital/caffeine/codeine.

Important safety information:

  • Acetaminophen/butalbital/caffeine/codeine may cause drowsiness, dizziness, or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Use acetaminophen/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, muscle relaxers, sleep aids) while you are using acetaminophen/butalbital/caffeine/codeine; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Do NOT take more than the recommended dose, take more often than prescribed, or take for longer than prescribed without checking with your doctor.
  • Pain medicines work best if they are used as the first signs of pain (or headache) occur. If you wait until the pain has significantly worsened, the pain medicine may not work as well.
  • Acetaminophen/butalbital/caffeine/codeine has acetaminophen in it. Before you start any new medicine, check the label to see if it has acetaminophen in it too. If it does or if you are not sure, check with your doctor or pharmacist.
  • Contact your doctor right away if you take more than 4,000 mg of acetaminophen per day, even if you feel well.
  • Acetaminophen/butalbital/caffeine/codeine may harm your liver. Your risk may be greater if you drink alcohol while you are using acetaminophen/butalbital/caffeine/codeine. Talk to your doctor before you take acetaminophen/butalbital/caffeine/codeine or other fever reducers if you drink alcohol.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
  • Acetaminophen/butalbital/caffeine/codeine may cause constipation. Talk with your doctor or pharmacist about using a stool softener or laxative to prevent constipation. It is also important to maintain a diet adequate in fiber, drink plenty of water, and exercise to prevent constipation. If you become constipated while taking acetaminophen/butalbital/caffeine/codeine, talk with your doctor or pharmacist.
  • Tell your doctor or dentist that you take acetaminophen/butalbital/caffeine/codeine before you receive any medical or dental care, emergency care, or surgery.
  • Hormonal birth control (eg, birth control pills) may not work as well while you are using acetaminophen/butalbital/caffeine/codeine. To prevent pregnancy, use an extra form of birth control (eg, condoms).
  • Acetaminophen/butalbital/caffeine/codeine may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking acetaminophen/butalbital/caffeine/codeine.
  • Use acetaminophen/butalbital/caffeine/codeine with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, excitement, depression, drowsiness, and breathing problems.
  • Acetaminophen/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 acetaminophen/butalbital/caffeine/codeine while you are pregnant. Long-term use of acetaminophen/butalbital/caffeine/codeine during pregnancy may cause dependence in the fetus or newborn. Discuss any questions or concerns with your doctor. Acetaminophen/butalbital/caffeine/codeine is found in breast milk. Do not breast-feed while taking acetaminophen/butalbital/caffeine/codeine.

When used for long periods of time or at high doses, acetaminophen/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 acetaminophen/butalbital/caffeine/codeine stops working well. Do not take more than prescribed.

Some people who use acetaminophen/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 acetaminophen/butalbital/caffeine/codeine, you may experience WITHDRAWAL symptoms including anxiety; confusion; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; hallucinations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seizures; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of acetaminophen/ 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:

Constipation; dizziness; drowsiness; intoxicated feeling; light-headedness; mild stomach pain; nausea; vomiting.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); change in the amount of urine produced; confusion; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes (eg, agitation, anxiety, depression); numbness or tingling; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe or persistent constipation; severe or persistent dizziness, drowsiness, headache, or light-headedness; shortness of breath; slow, shallow, or difficult breathing; sluggishness; symptoms of liver problems (eg, yellowing of the eyes or skin, dark urine, pale stools, loss of appetite, severe or persistent nausea or stomach pain); tremors; trouble urinating; unusual bruising or bleeding; unusual tiredness or weakness; vision changes.

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. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include bluish skin or nails; cold and clammy skin; coma; confusion; decreased urination; delirium; fainting; fast, slow, or irregular heartbeat; limp muscles; loss of consciousness; pinpoint pupils; restlessness; seizures; severe drowsiness, dizziness, or light-headedness; severe or persistent nausea or vomiting; shortness of breath; slow, shallow, or difficult breathing; symptoms of liver problems (eg, yellowing of the eyes or skin, dark urine, pale stools, loss of appetite, severe or persistent stomach pain); tremor; trouble sleeping; unusual bruising or bleeding; unusual sweating or tiredness.

Proper storage of acetaminophen/butalbital/caffeine/codeine:

Store acetaminophen/butalbital/caffeine/codeine at room temperature, below 86 degrees F (30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep acetaminophen/butalbital/caffeine/codeine out of the reach of children and away from pets.

General information:

  • If you have any questions about acetaminophen/butalbital/caffeine/codeine, please talk with your doctor, pharmacist, or other health care provider.
  • Acetaminophen/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.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take acetaminophen/butalbital/caffeine/codeine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about acetaminophen/butalbital/caffeine/codeine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to acetaminophen/butalbital/caffeine/codeine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using acetaminophen/butalbital/caffeine/codeine.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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