Butalbital, Aspirin, Caffeine, Codeine Phosphate Oral capsule

What is this medicine?

ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE (AS pir in; byoo TAL bi tal; KAF een; KOE deen) is a pain reliever. It is used to treat tension headaches.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• brain tumor

• drink more than 3 alcohol-containing drinks per day

• drug abuse or addiction

• head injury

• heart or circulation problems

• hemophilia, von Willebrand's disease, low platelets, or other bleeding problems

• kidney disease or problems going to the bathroom

• liver disease

• lung disease like asthma or emphysema

• peptic ulcer disease

• porphyria

• an unusual or allergic reaction to aspirin or salicylates, butalbital or other barbiturates, caffeine, codeine or other opioid analgesics, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth. Swallow it with a full glass of water. Follow the directions on the prescription label. If the medicine upsets your stomach, take the medicine with food or milk. Do not take more than you are told to take.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed. Caution should be used in children, especially teenagers, that have the chicken pox or flu.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• alcohol

• cidofovir

• furazolidone

• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate

• methotrexate

• probenecid

• procarbazine

• voriconazole

• warfarin

This medicine may also interact with the following medications:

• antihistamines

• benzodiazepines

• certain medicines for depression, anxiety, or psychotic disturbances

• certain medicines for sleep

• heparin and low molecular weight heparin like enoxaparin, dalteparin, and tinzaparin

• muscle relaxants

• narcotic medicines (opiates) for pain

• NSAIDs, medicines for pain and inflammation, like ibuprofen or naproxen

• phenothiazines like perphenazine, thioridazine, chlorpromazine, mesoridazine, fluphenazine, prochlorperazine, promazine, and trifluoperazine

• tramadol

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Tell your doctor or health care professional if your pain does not go away, if it gets worse, or if you have new or a different type of pain. You may develop tolerance to the medicine. Tolerance means that you will need a higher dose of the medicine for pain relief. Tolerance is normal and is expected if you take the medicine for a long time.

Do not suddenly stop taking your medicine because you may develop a severe reaction. Your body becomes used to the medicine. This does NOT mean you are addicted. Addiction is a behavior related to getting and using a drug for a non-medical reason. If you have pain, you have a medical reason to take pain medicine. Your doctor will tell you how much medicine to take. If your doctor wants you to stop the medicine, the dose will be slowly lowered over time to avoid any side effects.

You may get drowsy or dizzy when you first start taking the medicine or change doses. Do not drive, use machinery, or do anything that may be dangerous until you know how the medicine affects you. Stand or sit up slowly.

Children may be at higher risk for side effects. If your child has slow breathing, noisy breathing, confusion, or unusual sleepiness, stop giving this medicine and get medical help right away.

There are different types of narcotic medicines (opiates) for pain. If you take more than one type at the same time, you may have more side effects. Give your health care provider a list of all medicines you use. Your doctor will tell you how much medicine to take. Do not take more medicine than directed. Call emergency for help if you have problems breathing.

Too much aspirin can be very dangerous. Do not take aspirin or medicines that contain aspirin with this medicine. Many non-prescription medicines contain aspirin. Always read the labels carefully.

This medicine will cause constipation. Try to have a bowel movement at least every 2 to 3 days. If you do not have a bowel movement for 3 days, call your doctor or health care professional.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• confusion

• feeling faint or lightheaded, falls

• redness, blistering, peeling or loosening of the skin, including inside the mouth

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• dizziness

• drowsiness

• nausea, vomiting

• stomach pain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children. This medicine can be abused. Keep your medicine in a safe place to protect it from theft. Do not share this medicine with anyone. Selling or giving away this medicine is dangerous and against the law.

Store at room temperature below 25 degrees C (77 degrees F). Keep container tightly closed.

Throw away any unused medicine after the expiration date. Discard unused medicine and used packaging carefully. Pets and children can be harmed if they find used or lost packages.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.