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Butalbital, Aspirin, Caffeine, and Codeine

Generic Name: Butalbital, Aspirin, Caffeine, and Codeine (byoo TAL bi tal, AS pir in, KAF een, & KOE deen)
Brand Name: Ascomp with Codeine, Fiorinal with Codeine

For all patients taking this medicine:
  • This medicine may be habit-forming with long-term use.
  • This medicine is a strong pain drug that can put you at risk for addiction, abuse, and misuse. Misuse or abuse of butalbital, aspirin, caffeine, and codeine can lead to overdose and death. Talk with your doctor.
  • You will be watched closely to make sure you do not misuse, abuse, or become addicted to this medicine.
  • This medicine may cause very bad and sometimes deadly breathing problems. Call your doctor right away if you have slow, shallow, or trouble breathing.
  • The chance of very bad and sometimes deadly breathing problems may be greater when you first start butalbital, aspirin, caffeine, and codeine or anytime your dose is raised.
  • Even one dose of this medicine may be deadly if it is taken by someone else or by accident, especially in children. If butalbital, aspirin, caffeine, and codeine is taken by someone else or by accident, get medical help right away.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Using this medicine for a long time during pregnancy may lead to withdrawal in the newborn baby. This can be life-threatening. Talk with the doctor.
  • This medicine has an opioid drug in it. The use of opioid drugs along with a benzodiazepine drug or other drugs that may make you drowsy or slow your actions has led to very bad side effects. Side effects that have happened include slowed or trouble breathing and deaths. Benzodiazepine drugs include drugs like alprazolam, diazepam, and lorazepam. Benzodiazepine drugs are used to treat many health problems like anxiety, trouble sleeping, or seizures. Talk with the doctor.
  • Many drugs interact with butalbital, aspirin, caffeine, and codeine and can raise the chance of side effects like deadly breathing problems. Talk with your doctor and pharmacist to make sure it is safe to use this medicine with all of your drugs.
  • Do not take with alcohol or products that have alcohol. Unsafe and sometimes deadly effects may happen.
  • Get medical help right away if you feel very sleepy, very dizzy, or if you pass out. Caregivers or others need to get medical help right away if the patient does not respond, does not answer or react like normal, or will not wake up.
Children:
  • This medicine is not approved for use in children. Do not give to a child younger than 12 years of age. Children between 12 and 18 years of age who are very overweight or have certain other health problems like sleep apnea or other lung or breathing problems must not use this drug. If your child has been given butalbital, aspirin, caffeine, and codeine, ask the doctor for information about the benefits and risks.
  • Some children have had very bad and sometimes deadly breathing problems when using codeine after surgery to remove tonsils or adenoids. Do not give to a child younger than 18 years of age who has had surgery to remove tonsils or adenoids. Talk with your child's doctor.

Uses of Butalbital, Aspirin, Caffeine, and Codeine:

  • It is used to treat tension headaches.

What do I need to tell my doctor BEFORE I take Butalbital, Aspirin, Caffeine, and Codeine?

  • If you have an allergy to butalbital, aspirin, caffeine, codeine, or any other part of this medicine.
  • If you have an allergy to aspirin or NSAIDs.
  • If you have gotten nasal polyps or had swelling of the mouth, face, lips, tongue, or throat; unusual hoarseness; or trouble breathing with aspirin or NSAID use.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have any of these health problems: Lung or breathing problems like asthma, trouble breathing, or sleep apnea; high levels of carbon dioxide in the blood; or stomach or bowel block or narrowing.
  • If you have hemophilia.
  • If you have Reye's syndrome.
  • If you have kidney disease.
  • If you have taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for Parkinson's disease like selegiline or rasagiline in the last 14 days. Taking butalbital, aspirin, caffeine, and codeine within 14 days of those drugs can cause very bad high blood pressure.
  • If you are taking any of these drugs: Linezolid or methylene blue.
  • If you are taking any of these drugs: Buprenorphine, butorphanol, nalbuphine, or pentazocine.
  • If you are taking probenecid.
  • If you are taking any other NSAID.
  • If you are pregnant or may be pregnant. Do not take this medicine if you are in the third trimester of pregnancy. You may also need to avoid butalbital, aspirin, caffeine, and codeine at other times during pregnancy. Talk with your doctor to see when you need to avoid taking this medicine during pregnancy.
  • If you are breast-feeding. Do not breast-feed while you take butalbital, aspirin, caffeine, and codeine.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take butalbital, aspirin, caffeine, and codeine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Butalbital, Aspirin, Caffeine, and Codeine?

  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid driving and doing other tasks or actions that call for you to be alert until you see how butalbital, aspirin, caffeine, and codeine affects you.
  • To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
  • You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
  • If you are taking aspirin to help prevent a heart attack, talk with your doctor.
  • This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take this medicine.
  • Do not take butalbital, aspirin, caffeine, and codeine with other strong pain drugs or if you are using a pain patch without talking to your doctor first.
  • Limit your use of caffeine (for example, tea, coffee, cola) and chocolate. Use with this medicine may cause nervousness, shakiness, and a fast heartbeat.
  • Taking an opioid drug like butalbital, aspirin, caffeine, and codeine may lead to a rare but very bad adrenal gland problem. Call your doctor right away if you have very bad dizziness or passing out, very bad upset stomach or throwing up, or if you feel less hungry, very tired, or very weak.
  • Long-term use of an opioid drug like this medicine may lead to lower sex hormone levels. This may lead to signs like change in sex ability in men, no menstrual period in women, lowered interest in sex, or fertility problems. Call your doctor if you have any of these signs.
  • This medicine may raise the chance of seizures in some people, including people who have had seizures in the past. Talk to your doctor to see if you have a greater chance of seizures while taking butalbital, aspirin, caffeine, and codeine.
  • If you are 65 or older, use this medicine with care. You could have more side effects.
  • The chance of very bad side effects may be higher in children. This may be more likely to happen in children who have breathing problems. Deadly breathing problems have happened with the use of codeine in some children. Talk with the doctor.
  • Do not give to children and teenagers who have or are getting better from flu signs, chickenpox, or other viral infections due to the chance of Reye's syndrome. Reye's syndrome causes very bad problems to the brain and liver.
  • This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking butalbital, aspirin, caffeine, and codeine, call your doctor right away.

How is this medicine (Butalbital, Aspirin, Caffeine, and Codeine) best taken?

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take by mouth only.
  • Take with or without food. Take with food if it causes an upset stomach.
  • If you have been taking butalbital, aspirin, caffeine, and codeine for a long time or at high doses, it may not work as well and you may need higher doses to get the same effect. This is known as tolerance. Call your doctor if this medicine stops working well. Do not take more than ordered.
  • If you have been taking butalbital, aspirin, caffeine, and codeine on a regular basis and you stop it all of a sudden, you may have signs of withdrawal. Do not stop taking this medicine all of a sudden without calling your doctor. Tell your doctor if you have any bad effects.

What do I do if I miss a dose?

  • If you take butalbital, aspirin, caffeine, and codeine on a regular basis, take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
  • Many times this medicine is taken on an as needed basis. Do not take more often than told by the doctor.

See also: Dosage Information (in more detail)

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
  • Trouble breathing, slow breathing, or shallow breathing.
  • Noisy breathing.
  • Feeling very sleepy.
  • Very bad dizziness or passing out.
  • Feeling confused.
  • Chest pain or pressure or a fast heartbeat.
  • Any unexplained bruising or bleeding.
  • Ringing in ears.
  • Seizures.
  • Very bad belly pain.
  • Very hard stools (constipation).
  • Feeling very tired or weak.
  • Mood changes.
  • A very bad and sometimes deadly health problem called serotonin syndrome may happen if you take butalbital, aspirin, caffeine, and codeine with drugs for depression, migraines, or certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; very bad diarrhea, upset stomach, or throwing up; or very bad headache.
  • Very bad stomach ulcers or bleeding can happen with this medicine. Taking it in high doses or for a long time, smoking, or drinking alcohol raises the chance of these side effects. Taking butalbital, aspirin, caffeine, and codeine with food will not lower the chance of these effects. Call your doctor or get medical help right away if you get very bad stomach or back pain; black, tarry, or bloody stools; throwing up blood or throw up that looks like coffee grounds; or weight gain or swelling that is not normal.

What are some other side effects of Butalbital, Aspirin, Caffeine, and Codeine?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Hard stools (constipation).
  • Dizziness.
  • Feeling sleepy.
  • Headache.
  • Upset stomach or throwing up.
  • Feeling tired or weak.
  • Belly pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

See also: Side effects (in more detail)

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Butalbital, Aspirin, Caffeine, and Codeine?

  • Store at room temperature.
  • Protect from light.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine is refilled. If you have any questions about butalbital, aspirin, caffeine, and codeine, please talk with the doctor, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about butalbital, aspirin, caffeine, and codeine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using butalbital, aspirin, caffeine, and codeine.

Review Date: October 4, 2017

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