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aspirin, butalbital, caffeine, and codeine

Pronunciation: AS pir in, bue TAL bi tal, KAF een, and KOE deen

Brand: Ascomp with Codeine, Fiorinal with Codeine

Fiorinal 3

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

Image of Fiorinal 3
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Fiorinal Codeine-WAT

capsule, blue/yellow, imprinted with FIORINAL CODEINE, WATSON 956

Image of Fiorinal Codeine-WAT
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What is the most important information I should know about this medication?

Multum nochild

Aspirin 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.

Multum emt

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.

Multum habit

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

What is aspirin, butalbital, caffeine, and codeine?

Aspirin is a salicylate (sa-LIS-il-ate). It works by reducing substances in the body that cause pain, fever, and inflammation.

Butalbital is a barbiturate. 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 an opioid pain medication. An opioid is sometimes called a narcotic.

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 not listed in this medication guide.

What should I discuss with my healthcare provider before taking this medication?

Multum donot

You should 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, Celebrex, Orudis, Indocin, Lodine, Voltaren, Toradol, Mobic, Relafen, Feldene, and others.

To make sure you can safely take aspirin, butalbital, caffeine, and codeine, tell your doctor if you have any of these other conditions:

  • liver or kidney disease;
  • asthma or other breathing disorders;
  • a history of head injury or brain tumor;
  • a history of heart attack, stroke, blood clot, or stomach ulcers;
  • low blood pressure;
  • a stomach or intestinal disorder;
  • curvature of the spine; or
  • mental illness, or a history of drug or alcohol addiction.
Multum habit

Codeine and butalbital may be habit forming and should be used only by the person for whom it was prescribed. Never share this medication with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

Multum nopreg

FDA pregnancy category C. Codeine and butalbital may cause addiction or withdrawal symptoms in a newborn if the mother takes the medication during pregnancy. Taking aspirin during late pregnancy may cause bleeding in the mother or the baby during delivery. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Multum nobrfeed

Codeine 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 without telling your doctor if you are breast-feeding a baby.

Multum nochild

Aspirin 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.

How should I take this medication?

Take exactly as prescribed. Never take this medication in larger amounts, or 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.

Multum donot

Do not stop using this medication suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using aspirin, butalbital, caffeine, and codeine.

Multum emt

If you need surgery, tell the surgeon ahead of time that you are using this medication. You may need to stop using the medicine for a short time.

Multum rt

Store at room temperature away from moisture and heat. Keep track of the amount of medicine used from each new bottle. Codeine is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

What happens if I miss a dose?

Since this medication 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. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Multum emt

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of 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 this medication?

Multum dizzy

This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how the medicine will affect you.

Multum donot

Ask a doctor or pharmacist before using any cough, cold, allergy, or pain medication. Aspirin and caffeine are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains aspirin or caffeine.

Multum noalcohol

Avoid drinking alcohol. It may increase your risk of stomach bleeding.

What are the possible side effects of this medication?

Multum emt

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Multum donot

Stop using this medication and call your doctor at once if you have a serious side effect such as:

  • shallow breathing, slow heart rate;
  • fast or pounding heart rate, muscle twitching;
  • confusion, unusual thoughts or behavior;
  • bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • problems with urination; or
  • nausea, upper stomach pain, itching, 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?

Multum dizzy

Before using this medication, 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.

Tell your doctor about all other medicines you use, especially:

  • bupropion (Wellbutrin, Zyban);
  • ciprofloxacin (Cipro);
  • insulin or oral diabetes medication;
  • naloxone (Narcan, Suboxone);
  • atropine (Atreza, Sal-Tropine), belladonna (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm Scop);
  • another salicylate such as Nuprin Backache Caplet, Kaopectate, KneeRelief, Pamprin Cramp Formula, Pepto-Bismol, Tricosal, Trilisate, and others;
  • bladder or urinary medicines such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare);
  • a blood thinner such as rivaroxaban (Xarelto), warfarin (Coumadin, Jantoven);
  • bowel cleansing preparations (Half Lytely, Fleet Prep Kit, Evac-Q-Kwik, GoLytely, Supraprep, and others);
  • bronchodilators such as ipratropium (Atrovent) or tiotropium (Spiriva);
  • diet pills, caffeine pills, or other stimulants (such as ADHD medications);
  • irritable bowel medicines such as dicyclomine (Bentyl), hyoscyamine (Hyomax), or propantheline (Pro Banthine);
  • an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate);
  • an NSAID such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others;
  • steroids (such as prednisone); or
  • ulcer medications such as glycopyrrolate (Robinul) or mepenzolate (Cantil).

This list is not complete and other drugs may interact with aspirin, butalbital, caffeine, and codeine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about aspirin, butalbital, caffeine, and codeine.


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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