Aspirin, butalbital, and caffeine
Generic name: aspirin, butalbital, and caffeine [ AS-pir-in, bue-TAL-bi-tal, KAF-een ]
Brand names: Fiorinal, Fiormor, Fiortal, Fortabs, Butalbital Compound, Idenal, Laniroif
Dosage forms: oral capsule (325 mg-50 mg-40 mg), oral tablet (325 mg-50 mg-40 mg)
Drug class: Analgesic combinations
What is aspirin, butalbital, and caffeine?
Aspirin, butalbital, and caffeine is a combination medicine used to treat symptoms of tension (muscle contraction) headaches. aspirin, butalbital, and caffeine is not for treating multiple headaches that come and go.
Aspirin, butalbital, and caffeine may also be used for purposes not listed in this medication guide.
This medicine may be habit-forming. Misuse can cause addiction, overdose, or death.
Before taking this medicine
You should not use aspirin, butalbital, and caffeine if you are allergic to aspirin, butalbital, or caffeine, or if you have:
a bleeding or blood clotting disorder such as hemophilia, von Willebrand's disease, low platelets;
severe vitamin K deficiency;
severe liver disease;
a severe allergic reaction (sneezing, runny or stuffy nose, wheezing) after taking aspirin or another NSAID (nonsteroidal anti-inflammatory drug) such as ibuprofen, celecoxib, diclofenac, indomethacin, meloxicam, naproxen, Advil, Motrin, Aleve, and others;
a stomach ulcer; or
porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system).
Not approved for use by anyone younger than 18 years old. Using this medicine in a child or teenager with flu symptoms or chickenpox can cause a serious or fatal condition called Reye's syndrome.
Tell your doctor if you have ever had:
liver or kidney disease;
a head injury or brain tumor;
a stomach or intestinal disorder;
an enlarged prostate or urination problems; or
Addison's disease (an adrenal gland disorder).
Do not use this medicine during pregnancy unless your doctor tells you to. Using butalbital during pregnancy may cause withdrawal symptoms in the newborn. Using aspirin in the last 20 weeks can harm the unborn baby or cause pregnancy complications.
Do not breastfeed.
How should I take aspirin, butalbital, and caffeine?
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the lowest effective dose for your condition.
Butalbital may be habit-forming. Misuse can cause addiction, overdose, or death. Keep the medication where others cannot get to it. Selling or giving away this medicine is against the law.
This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using aspirin, butalbital, and caffeine.
This medicine is usually prescribed for short-term use only. You may have withdrawal symptoms if you stop using the medicine suddenly after long-term use. Ask your doctor before stopping the medicine.
Store tightly closed at room temperature, away from moisture, heat, and light. Keep your medicine in a place where no one can use it improperly.
What happens if I miss a dose?
aspirin, butalbital, and caffeine is used when needed. If you are on a dosing schedule, skip any missed dose. Do not use two doses at one time.
Do not take more than 6 tablets or capsules in 24 hours.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of butalbital can be fatal.
Overdose may cause severe drowsiness, confusion, feeling restless, insomnia, tremors, fast or pounding heartbeats, vomiting, stomach pain, rapid breathing, feeling hot, ringing in your ears, weak or shallow breathing, bruising or bleeding, seizure (convulsions), fainting, or coma.
What should I avoid while taking aspirin, butalbital, and caffeine?
Avoid driving or hazardous activity until you know how aspirin, butalbital, and caffeine will affect you. Your reactions could be impaired.
Ask a doctor or pharmacist before using other medicines for pain, fever, swelling, or cold/flu symptoms. They may contain ingredients similar to aspirin (such as ibuprofen, ketoprofen, or naproxen).
Avoid drinking alcohol.
Aspirin, butalbital, and caffeine side effects
Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).
Stop taking this medicine and seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.
Aspirin, butalbital, and caffeine may cause serious side effects. Call your doctor at once if you have:
bloody or tarry stools;
coughing up blood or vomit that looks like coffee grounds; or
any bleeding that will not stop.
Common side effects of aspirin, butalbital, and caffeine may include:
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.
Aspirin, butalbital, and caffeine dosing information
Usual Adult Dose for Pain:
1 or 2 capsules orally every 4 hours as needed not to exceed 6 capsules per day
-Due to high rate of physical dependence, the extended use of this drug is not recommended.
-The safety and efficacy of treating multiple recurrent headaches with this product is not known.
Uses: For the relief of the symptom complex of tension (or muscle contraction) headache.
What other drugs will affect aspirin, butalbital, and caffeine?
Using aspirin, butalbital, and caffeine with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.
Tell your doctor about all your other medicines, especially:
insulin or oral diabetes medicine;
steroid medicine such as prednisone;
an MAO inhibitor--isocarboxazid, linezolid, methylene blue injection, phenelzine, tranylcypromine, and others; or
NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.
This list is not complete. Other drugs may affect aspirin, butalbital, and caffeine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.
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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.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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