Acetaminophen/Butalbital/Caffeine/Codeine

Generic Name: Acetaminophen/Butalbital/Caffeine/Codeine (a-SEET-a-MIN-oh-fen/bue-TAL-bi-tal/KAF-een/KOE-deen)Brand Name: Examples include Fioricet with Codeine and Phrenilin with Caffeine and Codeine

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 have severe diarrhea caused by antibiotics or food poisoning
  • you are taking quinidine or sodium oxybate (GHB)

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

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 have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to an opioid pain medicine (eg, morphine)
  • if you have liver, kidney, or heart problems; underactive thyroid; adrenal gland problems (eg, Addison disease); lung or breathing problems (eg, asthma); a blockage of your bowel or other stomach or bowel problem (eg, paralytic ileus); enlarged prostate; or trouble urinating
  • if you have a history of alcohol or other substance abuse or dependence; anxiety; depression; mental or mood problems; or suicidal thoughts or actions
  • if you have a head injury, increased pressure in the head, growths in the brain, or a history of seizures
  • if you are in very poor health, have trouble sleeping, or have had recent stomach or bowel surgery

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
  • Benzodiazepines (eg, chlordiazepoxide, temazepam), cimetidine, HIV protease inhibitors (eg, ritonavir), isoniazid, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), narcotic analgesics (eg, morphine), quinolone antibiotics (eg, ciprofloxacin), or sodium oxybate (GHB) because they may increase the risk of Acetaminophen/Butalbital/Caffeine/Codeine 's side effects
  • Naltrexone or quinidine because they may decrease Acetaminophen/Butalbital/Caffeine/Codeine 's effectiveness
  • Beta-blockers (eg, atenolol), clozapine, corticosteroids (eg, prednisone), doxycycline, estrogens (eg, birth control, estradiol), or metronidazole 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
  • Medicines that may harm the liver (eg, acetaminophen, certain medicines for HIV infection, isoniazid, 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

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.
  • Do not take more than 6 capsules in 24 hours
  • 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 blurred vision. 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 or take for longer than prescribed without checking with your doctor. Doing so may be habit-forming.
  • Pain medications work best if they are used as the first signs of pain (or migraine) 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.
  • 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 more than 3 drinks with alcohol per day.
  • 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 .
  • Lab tests, including liver and kidney function, may be performed while you use Acetaminophen/Butalbital/Caffeine/Codeine . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Acetaminophen/Butalbital/Caffeine/Codeine with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, excitement, or depression.
  • 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: It is not known if Acetaminophen/Butalbital/Caffeine/Codeine can cause harm to the fetus. 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. Using Acetaminophen/Butalbital/Caffeine/Codeine during labor may cause harm to the infant. 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:

Dizziness; drowsiness; intoxicated feeling; lightheadedness; nausea; stomach pain; vomiting.

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); confusion; fainting; fast heartbeat; mental or mood changes; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe drowsiness; shortness of breath; slow or shallow breathing.

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 cold or clammy skin; confusion; dark urine; decreased urination; delirium; excessive sweating; fast or irregular heartbeat; loss of consciousness; pinpoint pupils; restlessness; seizures; severe drowsiness or dizziness; severe or persistent nausea or vomiting; severe or persistent trouble sleeping; slow or shallow breathing; tremor; unusual bruising or bleeding; yellowing of the skin or eyes.

Proper storage of Acetaminophen/Butalbital/Caffeine/Codeine :

Store Acetaminophen/Butalbital/Caffeine/Codeine 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.

This information is a summary only. It does not contain all information about Acetaminophen/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.