Butalbital/aspirin/caffeine (By mouth)

Introduction

Aspirin (AS-pir-in), Butalbital (bue-TAL-bi-tal), Caffeine (KAF-een)

Treats tension headaches and mild to moderate pain.Butalbital belongs to a group of drugs known as barbiturates (bar-bi-chur-ates).

How to Use This Medicine

Tablet, Capsule

• Your doctor will tell you how much medicine to take and how often.
• This medicine may be taken with food or milk to avoid stomach upset.
• Drink plenty of fluids to help avoid constipation.
• This medicine works best if you take it at the first sign of pain, rather than waiting until the pain is very strong.
• DO NOT increase your dose without your doctor's approval.
• If you have taken large amounts of this medicine or have taken it regularly for several weeks, do not suddenly quit using it without consulting your doctor.

If a dose is missed:

• Take it as soon as possible.
• If almost time for next dose, wait until then to take your medicine and skip the missed dose.
• You should not use two doses at the same time.

How to Store and Dispose of This Medicine

• Store in a tightly closed container away from heat and direct light.
• Keep all medicine away from children.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are taking any medicines that make you sleepy, such as tranquilizers or sleeping pills.
• Do not drink alcohol while taking this medicine.
• Steroids, diflunisal, prednisone, or phenylbutazone may cause stomach pain if taken while you are taking this medicine.
• Tell your doctor if you are taking a blood thinner (such as Coumadin®).

Warnings While Using This Medicine

• Talk with your doctor before taking this medicine if you have asthma, other lung disease, or liver or kidney problems.
• This medicine can cause drug dependence or addiction.
• If you are pregnant or breastfeeding, talk with your doctor before taking this medicine.
• Because this medicine makes some people dizzy or drowsy, be careful when driving a car or using machinery.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Brand Name(s)

Fiorinal, Aspirin/Butalbital/Caffeine

There may be other brand names for this medicine.

When This Medicine Should Not Be Used

You should not use this medicine if you have had an allergic reaction to: butalbital or related medicine such as phenobarbital or pentobarbital; aspirin, other salicylates, arthritis medicine such as ibuprofen (Motrin®), or caffeine. You should not use this medicine if you have porphyria. Do not give this medicine to a child who has a fever or symptoms of an infection. This drug should not be taken if you have stomach ulcers or a bleeding disorder.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Tightness in chest, shortness of breath or trouble breathing
• Fast, slowed, or pounding heartbeat
• Skin rash, hives, or intense itching
• Flushing of the face
• Swelling of the eyelids or face.

If you notice these less serious side effects, talk with your doctor:

• Lightheadedness, dizziness
• Drowsiness
• Upset stomach, constipation, gas
• Nausea, vomiting
• Sweating