Butalbital/aspirin/codeine/caffeine (By mouth)

Introduction

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

Relieves headaches and pain. Butalbital belongs to a group of drugs known as barbiturates. Codeine is a narcotic pain reliever.

When This Medicine Should Not Be Used

How to Use This Medicine

Capsule

• Your doctor will tell you how much to take and how often.
• This medicine may be taken with food or milk to avoid stomach upset.
• This medicine works best if you take it at the first sign of headache or pain.
• Drink plenty of fluids with this medicine to avoid constipation.
• If you have taken large amounts of this medicine or have taken it regularly for several weeks, do not suddenly stop taking it without talking to your doctor.

If a dose is missed:

• Take as soon as possible
• Skip the missed dose if it is almost time for your next regular dose.
• You should not use two doses at the same time.

How to Store and Dispose of This Medicine

• Store in 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.

• Avoid drinking alcohol while taking this medicine.
• Avoid taking drugs that can make you sleepy such as tranquilizers, sleeping pills, and some cough and cold medicines.
• Be sure to tell your doctor if you are taking a blood-thinning medicine (Coumadin®).

Brand Name(s)

Ascomp w/Codeine, Fiorinal w/Codeine

Warnings While Using This Medicine

• This medicine should not be taken by children or teenagers with symptoms of the flu or other viral infection.
• Make sure your doctor knows if you have asthma, other lung problems, or heart, liver, or kidney disease.
• This medicine can be habit-forming. DO NOT increase your dose unless your doctor tells you to do so.
• If you are pregnant or breastfeeding, talk to your doctor before taking this medicine.
• Because this medicine makes some people dizzy or drowsy, be careful when driving a car or using machinery.
• This medicine may cause constipation. This is more common if you use it for a long time. Ask your doctor if you should also use a laxative to prevent and treat constipation.
• When a mother is breastfeeding and takes codeine, there is a very small chance that this medicine could cause serious side effects in the baby. This is because codeine works differently in a few women, so their breast milk contains too much medicine. If you take codeine, be alert for these signs of overdose in your nursing baby: sleeping more than usual, trouble breastfeeding, trouble breathing, or being limp and weak. Call the baby's doctor right away if you think there is a problem. If you cannot talk to the doctor, take the baby to the emergency room or call 911.

Possible Side Effects While Using This Medicine

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

• Tightness of the chest or trouble breathing.
• Fast, slowed, or pounding heartbeat.
• Skin rash, hives, or intense itching.
• Swelling of the eyelids, face, or lips.
• Black or bloody stools.
• Ringing in the ears.

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

• Lightheadedness or dizziness.
• Drowsiness.
• Nausea, vomiting, or upset stomach.
• Constipation.
• Loss of appetite.

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