aspirin, butalbital, caffeine, and codeine

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aspirin, butalbital, caffeine, and codeine

Pronunciation:AS pir in, bue TAL bi tal, KAF een, and KOE deen
Brand:Fiorinal with Codeine

Fiorinal 3

blue/yellow, imprinted with S F-C, SANDOZ 78-107

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Fiorinal Codeine-WAT

blue/yellow, imprinted with FIORINAL CODEINE, WATSON 956

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What is the most important information I should know about aspirin, butalbital, caffeine, and codeine?

nochildAspirin should not be given to a child or teenager who has a fever, especially if the child also has flu symptoms or chicken pox. Aspirin can cause a serious and sometimes fatal condition called Reye's syndrome in children.

Stop using this medication and call your doctor at once if you have any symptoms of bleeding in your stomach or intestines. Symptoms include black, bloody, or tarry stools, and coughing up blood or vomit that looks like coffee grounds.

habitCodeine and butalbital may be habit-forming and should be used only by the person this medicine was prescribed for. Keep the medication in a secure place where others cannot get to it.

What is aspirin, butalbital, caffeine, and codeine?

Aspirin is in a group of drugs called salicylates (sa-LIS-il-ates). It works by reducing substances in the body that cause pain, fever, and inflammation.

Butalbital is in a group of drugs called barbiturates. It relaxes muscle contractions involved in a tension headache.

Caffeine is a central nervous system stimulant. It relaxes muscle contractions in blood vessels to improve blood flow.

Codeine is in a group of drugs called narcotic pain relievers.

The combination of aspirin, butalbital, caffeine, and codeine is used to treat tension headaches. This medicine is not for treating headaches that come and go.

This medication may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking aspirin, butalbital, caffeine, and codeine?

nochildAspirin should not be given to a child or teenager who has a fever, especially if the child also has flu symptoms or chicken pox. Aspirin can cause a serious and sometimes fatal condition called Reye's syndrome in children.
donotDo not use this medication if you are allergic to aspirin, butalbital, caffeine, or codeine, or if you have:
  • porphyria;
  • stomach ulcer;
  • a bleeding or blood clotting disorder; or
  • an allergy to an NSAID (non-steroidal anti-inflammatory drug) such as Advil, Motrin, Aleve, Orudis, Indocin, Lodine, Voltaren, Toradol, Mobic, Relafen, Feldene, and others.
habitCodeine and butalbital may be habit-forming and should be used only by the person this medicine was prescribed for. This medication should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before you take aspirin, butalbital, caffeine, and codeine, tell your doctor if you have:

  • a history of heart attack, stroke, blood clot, or stomach ulcers;
  • asthma or other breathing disorders;
  • liver or kidney disease;
  • a history of head injury or brain tumor;
  • low blood pressure;
  • a stomach or intestinal disorder;
  • curvature of the spine; or
  • mental illness, or a history of drug or alcohol addiction.
nopregFDA pregnancy category C. Codeine and butalbital may be harmful to an unborn baby, and could cause a birth defect, breathing problem, or addiction/withdrawal symptoms in a newborn. Taking aspirin during late pregnancy may cause bleeding in the mother or the baby during delivery. Do not take aspirin during pregnancy unless your doctor has told you to.
nobrfeedCodeine can pass into breast milk and may harm a nursing baby. The use of codeine by some nursing mothers may lead to life-threatening side effects in the baby. Do not use this medication if you are breast-feeding a baby.

How should I take aspirin, butalbital, caffeine, and codeine?

Take this medication exactly as it was prescribed for you. Do not take it in larger amounts, or use it for longer than recommended by your doctor. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

donotYou may have withdrawal symptoms when you stop using aspirin, butalbital, caffeine, and codeine after using it over a long period of time. Do not stop using this medication suddenly without first talking to your doctor. You may need to use less and less before you stop the medication completely.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using aspirin, butalbital, caffeine, and codeine. You may need to stop using the medicine for a short time.

rtStore aspirin, butalbital, caffeine, and codeine at room temperature away from moisture and heat.

Keep track of how many tablets have been used from each new bottle of this medicine. Codeine is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

What happens if I miss a dose?

Since aspirin, butalbital, caffeine, and codeine is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

emtSeek emergency medical attention if you think you have used too much of this medicine. An overdose of aspirin, butalbital, caffeine, and codeine can be fatal.

Overdose symptoms may include extreme drowsiness or insomnia, restless feeling, tremors, fast heart rate, pinpoint pupils, nausea, vomiting, dark urine, jaundice (yellowing of the skin or eyes), confusion, ringing in your ears, fainting, weak pulse, seizure (convulsions), blue lips, shallow breathing, or no breathing.

What should I avoid while taking aspirin, butalbital, caffeine, and codeine?

dizzyThis medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.
donotDo not use any other over-the-counter cough, cold, allergy, or pain medication without first asking your doctor or pharmacist. Aspirin and caffeine are contained in many medicines available over the counter. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains aspirin or caffeine.
noalcoholAvoid drinking alcohol while taking this medication. Alcohol may increase your risk of stomach bleeding.

While you are taking this medication, avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice.

What are the possible side effects of aspirin, butalbital, caffeine, and codeine?

emtGet emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
emtCall your doctor at once if you have any of these serious side effects:
  • shallow breathing, slow heart rate;
  • fast or pounding heart rate, muscle twitching;
  • confusion, unusual thoughts or behavior;
  • black, bloody, or tarry stools;
  • coughing up blood or vomit that looks like coffee grounds;
  • problems with urination; or
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects include:

  • feeling dizzy, shaky, anxious, or agitated;
  • heartburn, mild nausea, vomiting, upset stomach, constipation, diarrhea;
  • mood changes, sleep problems (insomnia);
  • sweating, urinating more than usual; or
  • ringing in your ears, blurred vision, or dry mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect aspirin, butalbital, caffeine, and codeine?

dizzyBefore taking this medicine, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by butalbital or codeine.

Before taking this medication, tell your doctor if you are using any of the following drugs:

  • a blood thinner such as warfarin (Coumadin);
  • an NSAID such as ibuprofen (Advil, Motrin), indomethacin (Indocin), ketoprofen (Orudis), naproxen (Aleve, Naprosyn), and others;
  • another salicylate such as Backache Relief Extra Strength, Novasal, Nuprin Backache Caplet, Doan's Pills Extra Strength, Tricosal, and others;
  • insulin or diabetes medications you take by mouth;
  • steroids (such as prednisone);
  • mercaptopurine (Purinethol);
  • sulfinpyrazone (Anturane);
  • ciprofloxacin (Cipro);
  • atropine (Donnatal, and others), dimenhydrinate (Dramamine), glycopyrrolate (Robinul), or scopolamine (Transderm-Scop);
  • bowel or bladder medications such as dicyclomine (Bentyl), solfenacin (Vesicare), tolterodine (Detrol) and others;
  • a bronchodilator such as ipratropium (Atrovent) or tiotropium (Spiriva); or
  • an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate).

If you are using any of these drugs, you may not be able to use aspirin, butalbital, caffeine, and codeine, or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect aspirin, butalbital, caffeine, and codeine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about this medication.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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