aspirin, butalbital, caffeine, and codeine

What is the most important information I should know about this medicine?

What is aspirin, butalbital, caffeine, and codeine?

Aspirin, butalbital, caffeine, and codeine is a combination medicine used to treat tension headaches after other treatments have failed. 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?

• severe asthma, asthma with runny nose and nasal polyps, or other breathing problems;
• a stomach or bowel obstruction (including paralytic ileus);
• an allergy to NSAIDs (nonsteroidal anti-inflammatory drugs);
• hemophilia; 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).

Tell your doctor if you have ever had:

• sleep apnea or other breathing disorders;
• a stomach ulcer or bowel obstruction;
• a vitamin K deficiency;
• seizures, head injury, or brain tumor;
• liver or kidney disease;
• alcoholism or a drug addiction;
• problems with your pancreas, thyroid, or gallbladder.
• urination problems; or
• if you take medicine to treat or prevent blood clots (such as warfarin, enoxaparin, clopidogrel, rivaroxaban, Coumadin, Effient, or Xarelto).

Do not give this medicine to a teenager with a fever, flu symptoms, or chickenpox. Aspirin can cause Reye's syndrome, a serious and sometimes fatal condition in adolescents.

Taking aspirin during late pregnancy may cause bleeding in the mother or the baby during delivery.

How should I take this medicine?

Follow the directions on your prescription label and read all medication guides. Use the lowest dose that is effective in treating your condition. Tell your doctor if you feel an increased urge to take more of this medicine.

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

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

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 dose. Do not use two doses at one time.

What happens if I overdose?

Overdose symptoms may include extreme drowsiness, confusion, muscle weakness, fast or slow heartbeats, restlessness, tremor, dilated or pinpoint pupils, ringing in your ears, feeling hot, vomiting, fainting, blue lips, cold and clammy skin, very slow breathing, seizure, or coma.

What should I avoid while taking this medicine?

What are the possible side effects of this medicine?

Opioid medicine can slow or stop your breathing, and death may occur. 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.

• noisy breathing, sighing, shallow breathing, breathing that stops during sleep;
• a slow heart rate or weak pulse;
• a light-headed feeling, like you might pass out;
• confusion, unusual thoughts or behavior;
• easy bruising or bleeding (nosebleeds, bleeding gums);
• 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.

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.

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?

You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C.

• cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic ("water pill");
• medicines for motion sickness, irritable bowel syndrome, or overactive bladder;
• other narcotic medications --opioid pain medicine or prescription cough medicine;
• a sedative like Valium --diazepam, alprazolam, lorazepam, Xanax, Klonopin, Versed, and others;
• drugs that make you sleepy or slow your breathing --a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness; or
• drugs that affect serotonin levels in your body --a stimulant, or medicine for depression, Parkinson's disease, migraine headaches, serious infections, or nausea and vomiting.

This list is not complete. Other drugs may affect aspirin, butalbital, caffeine, and codeine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.

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 1996-2023 Cerner Multum, Inc. Version: 13.02. Revision date: 10/14/2019.