Aspirin is a pain reliever, as well as an anti-inflammatory and a fever reducer. Butalbital is in a class of drugs called barbiturates that slow down your central nervous system (brain and nerve impulses) and cause relaxation. Caffeine is believed to constrict dilated blood vessels (veins and arteries) that may contribute to tension headaches.

Together, aspirin, butalbital, and caffeine are called Fiorinal. Fiorinal is used to relieve complex tension headaches, although precisely how it works is unknown. Fiorinal may also be used for purposes other than those listed here.

Take Fiorinal exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water. Take Fiorinal with food or milk if it upsets your stomach.

Never take more of this medication than is prescribed for you. Too much Fiorinal could be very harmful. Never take more than six tablets or capsules per day.

Do not share this medication with anyone else.

Do not take this drug if it begins to smell strongly of vinegar. This smell means that the aspirin in it is beginning to break down.

Store Fiorinal at room temperature away from moisture and heat.

Do not take Fiorinal without first talking to your doctor if you:

• drink more than three alcoholic beverages per day
• if you have a stomach ulcer
• if you have a bleeding or platelet disorder
• if you have recently had surgery

Before taking this medication, tell your doctor if you have:

• Kidney disease
• Liver disease
• Porphyria
• Asthma or another respiratory disease
• Fluid retention
• Congestive heart disease or another type of heart disease
• High blood pressure

You may not be able to take Fiorinal, or you may require a lower dose or special monitoring during treatment if you have any of the conditions listed above.

It is not known whether Fiorinal will harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. Fiorinal passes into breast milk and may harm a nursing infant. Do not take this medication without first talking to your doctor if you are breast-feeding a baby.

If you are older than 60 years of age, you may be more likely to experience side effects from this medication. Use extra caution.

Do not use Fiorinal to treat a child or teenager who has a fever, flu symptoms, or chicken pox without first talking to a doctor. In children younger than 20 years of age, aspirin may increase the risk of Reye's syndrome, a rare but often fatal condition.

Take the missed dose as soon as you remember. Do not take a double dose of this medication. Wait the prescribed amount of time before taking your next dose.

Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of Fiorinal overdose may include:

• Nausea
• Vomiting
• Slow breathing
• Seizures
• Dizziness
• Weakness
• Loss of consciousness
• Coma
• Confusion
• Tiredness
• Cold and clammy skin
• Fast heartbeat
• Small pupils
• Ringing in your ears
• Sweating

Use caution when driving, operating machinery, or performing other hazardous activities. Butalbital may cause drowsiness or dizziness. If you experience drowsiness or dizziness, avoid these activities.

Avoid alcohol. Alcohol taken during therapy with Fiorinal can increase the risk of stomach bleeding and can increase drowsiness and dizziness.

Side Effects

Get EMERGENCY medical help if you have any of these signs of an allergic reaction:

• Hives
• Difficulty breathing
• Swelling of your face, lips, tongue, or throat

If you experience any of the following serious side effects, stop taking Fiorinal and seek emergency medical attention:

• Slow, weak breathing
• Severe weakness or dizziness
• Black, bloody, or tarry stools or blood in your urine or vomit

Other, less serious side effects may be more likely to occur. Continue to take Fiorinal and talk to your doctor if you experience:

• Dry mouth, nausea, vomiting, or decreased appetite
• Dizziness, tiredness, or lightheadedness
• Ringing in your ears

Butalbital may be habit forming. Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

Do not take Fiorinal if you have taken a monoamine oxidase inhibitor (MAOI) such as:

• Isocarboxazid (Marplan®)
• Phenelzine (Nardil®)
• Tranylcypromine (Parnate®)

in the last 14 days. Dangerous sedation could result.

Fiorinal may increase the effects of other drugs that cause drowsiness including:

• antidepressants
• alcohol
• antihistamines
• sedatives (used to treat insomnia)
• pain relievers
• anxiety medicines
• muscle relaxants

Tell your doctor about all medicines that you are taking, and do not take any medicine unless your doctor approves.

Dangerous side effects may occur if aspirin is taken with any of the following medicines:

• warfarin (Coumadin®)
• probenecid (Benemid®)
• sulfinpyrazone (Anturane®)
• ibuprofen (Motrin®, Advil®, Nuprin®)
• ketoprofen (Orudis®, Orudis KT®, Oruvail®)
• naproxen (Naprosyn®, Anaprox®, Aleve®)
• choline salicylate and magnesium salicylate
• prednisone (Deltasone®)
• prednisolone (Prelone®, Pediapred®)
• methylprednisolone (Medrol®)
• dexamethasone (Decadron®)
• glipizide (Glucotrol®)
• glyburide (Micronase®, Diabeta®, Glynase®)

Do not take this medication without first talking to your doctor if you are taking any of the medications listed above.

Many other medicines contain aspirin, especially over-the-counter pain, fever, cold, and allergy medications. Too much aspirin can be very dangerous.

Drugs other than those listed here may also interact with Fiorinal. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.