aspirin, butalbital, caffeine, and codeine

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

Brand: Ascomp with Codeine, Fiorinal with Codeine

Fiorinal 3

slide 1 of 2, Fiorinal 3,

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

Image of Fiorinal 3
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Fiorinal Codeine-WAT

slide 2 of 2, 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 medicine?

Codeine can slow or stop your breathing, and may be habit-forming. MISUSE OF THIS MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

Taking this medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Fatal side effects can occur if you use this medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.

You should not use this medicine if you have severe breathing problems, hemophilia, a stomach or bowel obstruction, severe allergy to any NSAID, if you are pregnant, or if you have used certain medicines in the past 14 days.

This medicine is not for use in children. Codeine breaks down rapidly in a child and can cause dangerously slow breathing or death.

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 (sometimes called a narcotic).

Aspirin, butalbital, caffeine, and codeine is a combination medicine 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 medicine?

Aspirin may cause stomach or intestinal bleeding, which can be fatal. This can occur without warning while you are taking this medicine.

You should not use this medicine if you are allergic to aspirin, butalbital, caffeine, or codeine, or if you have:

  • trouble breathing, severe asthma or other lung disorders;
  • hemophilia or other bleeding disorder;
  • a stomach or bowel obstruction (including paralytic ileus);
  • asthma, or a history of severe allergic reaction (sneezing, runny or stuffy nose, wheezing, shortness of breath) after taking aspirin or another NSAID (nonsteroidal anti-inflammatory drug); or
  • if you have used an MAO inhibitor in the past 14 days (such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine).

This medicine is not recommended for use in children, and should not be given to a child or teenager who has a fever, or a child who has had surgery to remove the tonsils or adenoids.

In some people, codeine breaks down rapidly in the liver and reaches higher than normal levels in the body. This can cause dangerously slow breathing and may cause death, especially in a child.

To make sure aspirin, butalbital, caffeine, and codeine is safe for you, tell your doctor if you have:

  • a vitamin K deficiency;
  • liver or kidney disease;
  • a history of seizure, head, injury or brain tumor;
  • a stomach ulcer or bowel obstruction;
  • problems with your pancreas, gallbladder, thyroid or adrenal gland;
  • a history of drug or alcohol addiction; or
  • if you use a sedative, street drugs, or other medicines that make you sleepy or slow your breathing.

Tell your doctor if you are pregnant. If you use this medicine while you are pregnant, your baby could become dependent on the butalbital or codeine. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Taking aspirin during late pregnancy may cause bleeding in the mother or the baby during delivery.

This medicine can pass into breast milk and may lead to life-threatening side effects in the baby. Do not breast-feed while taking this medicine.

How should I take this medicine?

Follow all directions on your prescription label. Codeine can slow or stop your breathing. Never use this medicine in larger amounts, or for longer than prescribed. Tell your doctor if the medicine seems to stop working as well in relieving your headaches.

Butalbital and codeine may be habit-forming, even at regular doses. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE OF THIS MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Selling or giving away aspirin, butalbital, caffeine, and codeine is against the law.

If you need surgery or medical tests, tell the surgeon ahead of time that you are using this medicine.

Do not stop using this medicine suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop the medicine.

Store at room temperature away from moisture and heat. Keep track of the amount of medicine used from each new bottle. Butalbital and codeine are drugs 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 medicine is used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of butalbital or codeine can be fatal.

Overdose symptoms may include severe drowsiness or insomnia, tremors, pinpoint pupils, 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 medicine?

This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how the medicine will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Ask a doctor or pharmacist before using any cold, allergy, or pain medication. Many medicines available over the counter contain aspirin or similar medicines. Taking certain products together can cause you to get too much of this type of medication.

Do not drink alcohol. Dangerous side effects or death could occur.

What are the possible side effects of this medicine?

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

Like other narcotic medicines, codeine can slow your breathing. Death may occur if breathing becomes too weak.

Seek emergency medical attention if a child who has taken this medicine has any of the following life-threatening side effects: noisy breathing, sighing, slow breathing with long pauses between breaths; being unusually sleepy or hard to wake up; blue colored lips.

Call your doctor at once if you have:

  • weak or shallow breathing;
  • a light-headed feeling, like you might pass out;
  • confusion, unusual thoughts or behavior;
  • severe constipation;
  • symptoms of stomach bleeding --bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or
  • symptoms of low adrenal gland hormones --worsening tiredness or muscle weakness, feeling light-headed, nausea, vomiting, and loss of appetite.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Serious side effects may be more likely in older adults and those who are ill or debilitated.

Common side effects include:

  • nausea, vomiting, stomach pain, constipation;
  • headache, dizziness, drowsiness; or
  • feeling tired.

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.

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

This medicine can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

  • certain antibiotics or antifungal medications, or medicines to treat HIV or AIDS;
  • seizure medicine, heart or blood pressure medication;
  • opioid pain medicine or prescription cough medicine;
  • drugs that make you sleepy or slow your breathing --a sleeping pill, muscle relaxer, sedative, tranquilizer, or antipsychotic medicine;
  • drugs that affect serotonin levels in your body --medicine for depression, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting;
  • medication to prevent blood clots --clopidogrel, rivaroxaban, warfarin, Coumadin, or others; or
  • an NSAID --diclofenac, ibuprofen (Advil, Motrin), ketorolac, naproxen.

This list is not complete and many other drugs can interact with aspirin, butalbital, caffeine, and codeine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you. Not all possible interactions are listed in this medication guide.

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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