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Butalbital/acetaminophen/caffeine/codeine (By mouth)

Acetaminophen (a-seet-a-MIN-oh-fen), Butalbital (bue-TAL-bi-tal), Caffeine (KAF-een), Codeine Phosphate (KOE-deen FOS-fate)

Treats pain, including headaches. Contains a barbiturate and a narcotic pain reliever.

Brand Name(s):

Fioricet w/Codeine, Fioricet with Codeine

There may be other brand names for this medicine.

When This Medicine Should Not Be Used:

This medicine is not right for everyone. Do not use if you had an allergic reaction to butalbital, acetaminophen, caffeine, or codeine, or if you have porphyria. Do not give this medicine to a child who has just had surgery to remove tonsils and adenoids.

How to Use This Medicine:

Capsule

  • Take your medicine as directed.
  • This medicine is not for long-term use.
  • 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.

  • This combination medicine contains acetaminophen. Carefully check the labels of all other medicines you are using because they may also contain acetaminophen. It is not safe to take more than 4 grams (4,000 milligrams) of acetaminophen in one day (24 hours).
  • Some foods and medicines can affect how Fioricet® with codeine works. Tell your doctor knows if you are using an MAO inhibitor.
  • 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.
  • Do not drink alcohol while you are using this medicine. Acetaminophen can damage your liver, and drinking alcohol can increase this risk.

Warnings While Using This Medicine:

  • Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, adrenal problems (such as Addison disease), enlarged prostate, trouble urinating, underactive thyroid, or stomach problems. Tell your doctor if you have had a head injury, or if you have been addicted to drugs or alcohol.
  • This medicine may cause the following problems:
    • Liver damage
    • Serious skin reactions
  • This medicine may make you dizzy or drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
  • If you think you may have taken an overdose of this medicine, get emergency help at once.
  • 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 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, or red skin rash
  • Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
  • Dizziness, lightheadedness, or fainting
  • Extreme dizziness, drowsiness, or weakness, trouble breathing, slow heartbeat or breathing, seizures, and cold, clammy skin
  • Trouble breathing, slow or shallow breathing

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

  • Constipation

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: 7/4/2014


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