Butalbital, Acetaminophen, Caffeine, Codeine Phosphate Oral capsule

What is this medicine?

ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE (a set a MEE noe fen; 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:

• breathing problems

• drug abuse or addiction

• if you often drink alcohol

• liver disease

• intestinal problem

• porphyria

• recent head injury

• an unusual or allergic reaction to acetaminophen, butalbital or other barbiturates, caffeine, codeine, 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 with a full glass of water. Follow the directions on the prescription label. Do not take your medicine more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Patients over 65 years old may have a stronger reaction and need a smaller dose.

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

• linezolid

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

• narcotic pain relievers

• procarbazine

• voriconazole

This medicine may also interact with the following medications:

• antihistamines for allergy, cough and cold

• barbiturates like phenobarbital

• naltrexone

• medicines for depression, anxiety, or psychotic disturbances

• medicines for sleep

• medicines used for sleep during surgery

• muscle relaxers

• other medicines with acetaminophen

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. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

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.

This medicine may 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.

Do not take other medicines that contain acetaminophen with this medicine. Always read labels carefully. If you have questions, ask your doctor or pharmacist.

If you take too much acetaminophen get medical help right away. Too much acetaminophen can be very dangerous and cause liver damage. Even if you do not have symptoms, it is important to get help right away.

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

• anxiety, irritable, excited

• difficulty passing urine

• breathing problems

• confusion

• fast, irregular heartbeat

• feeling faint or lightheaded

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

• seizures

• yellowing of the eyes or skin

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

• constipation

• drowsiness, dizziness

• dry mouth

• headache

• nausea, vomiting

• passing urine more often

• 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 between 15 and 30 degrees C (59 and 86 degrees F). Keep container tightly closed. Throw away any unused medicine after the expiration date.