What is the most important information I should know about this medicine?
This medicine 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.
This medicine is not for use in anyone under 18.
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.
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 that relaxes muscle contractions. Caffeine is a stimulant that relaxes 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).
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.
Do not give this medicine to anyone younger than 18 years old.
Do not breast-feed. Codeine can pass into breast milk and may cause drowsiness, breathing problems, or death in a nursing baby.
To make sure this medicine is safe for you, tell your doctor if you have ever had:
- a vitamin K deficiency;
- liver or kidney disease;
- seizures, head injury, or brain tumor;
- a stomach ulcer or bowel obstruction;
- problems with your pancreas, gallbladder, thyroid or adrenal gland; or
- drug or alcohol addiction.
If you use butalbital or codeine while you are pregnant, your baby could become dependent on these drugs. 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.
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 your medicine. Butalbital and codeine are drugs of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.
Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush the unused medicine down the toilet.
What happens if I miss a dose?
Since this medicine is used for pain, you are not likely to miss a dose. Skip any 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, especially in a child or another person using the medicine without a prescription.
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, very slow breathing, or coma.
What should I avoid while taking this medicine?
Do not drink alcohol. Dangerous side effects or death could occur.
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 combination medicines contain aspirin or similar medicines. Taking certain products together can cause you to get too much of this type of medication.
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.
A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.
Call your doctor at once if you have:
- noisy breathing, sighing, shallow breathing;
- a slow heart rate or weak pulse;
- 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
-
low cortisol levels -- nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.
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 overweight, malnourished, or debilitated.
Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.
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:
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other narcotic medications --opioid pain medicine or prescription cough medicine;
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a sedative like Valium --diazepam, alprazolam, lorazepam, Ativan, Klonopin, Restoril, Tranxene, Versed, Xanax, and others;
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drugs that make you sleepy or slow your breathing --a sleeping pill, muscle relaxer, tranquilizer, antidepressant, or antipsychotic medicine; or
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drugs that affect serotonin levels in your body --a stimulant, or medicine for depression, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting.
This list is not complete. Other drugs may interact with aspirin, butalbital, caffeine, and codeine, including prescription and over-the-counter medicines, vitamins, and herbal products. 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.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2018 Cerner Multum, Inc. Version: 12.01. Revision date: 1/15/2018.
