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aspirin, butalbital, and caffeine

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

Brand: Fiorinal


slide 1 of 7, Aspirin/Butalbital/Caffeine,

325 mg-50 mg-40 mg, round, white, imprinted with West-ward 785

 Image of Aspirin/Butalbital/Caffeine
slide 1 of 7


slide 2 of 7, Aspirin/Butalbital/Caffeine,

325 mg-50 mg-40 mg, capsule, dark green/light green, imprinted with LANNETT, 0527/1552

 Image of Aspirin/Butalbital/Caffeine
slide 2 of 7


slide 3 of 7, Aspirin/Butalbital/Caffeine,

325 mg-50 mg-40 mg, capsule, green/yellow, imprinted with WATSON, 3219

 Image of Aspirin/Butalbital/Caffeine
slide 3 of 7


slide 4 of 7, Fiorinal,

325 mg-50 mg-40 mg, capsule, dark green/light green, imprinted with FIORINAL 955

 Image of Fiorinal
slide 4 of 7


slide 5 of 7, Aspirin/Butalbital/Caffeine,

325 mg-50 mg-40 mg, round, white, imprinted with R, 023

 Image of Aspirin/Butalbital/Caffeine
slide 5 of 7

Butalbital Compound

slide 6 of 7, Butalbital Compound,

325 mg-50 mg-40 mg, round, white, imprinted with West-ward 785

 Image of Butalbital Compound
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slide 7 of 7, Fiorinal,

325 mg-50 mg-40 mg, capsule, dark green/light green, imprinted with FIORINAL 955

 Image of Fiorinal
slide 7 of 7

What is the most important information I should know about aspirin, butalbital, and caffeine?

This medicine may be habit-forming. Misuse can cause addiction, overdose, or death.

What is aspirin, butalbital, and caffeine?

Aspirin, butalbital, and caffeine is a combination medicine used to treat symptoms of tension (muscle contraction) headaches. This medicine 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.

What should I discuss with my healthcare provider before taking aspirin, butalbital, and caffeine?

You should not use this medicine 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;
  • bleeding problems;
  • a head injury or brain tumor;
  • a stomach or intestinal disorder;
  • underactive thyroid;
  • allergies;
  • 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?

This medicine 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 this medicine 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.

What are the possible side effects of aspirin, butalbital, and caffeine?

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.

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 may include:

  • drowsiness; or
  • dizziness.

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, and caffeine?

Using this medicine 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:

  • mercaptopurine;
  • methotrexate;
  • probenecid;
  • a blood thinner such as warfarin, Coumadin, Jantoven;
  • 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.

Where can I get more information?

Your pharmacist can provide more information about aspirin, butalbital, and caffeine.

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: 3.01. Revision date: 9/8/2021.

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