Uses of Butalbital, Acetaminophen, Caffeine, and Codeine:

• It is used to treat tension headaches.

What do I need to tell my doctor BEFORE I take Butalbital, Acetaminophen, Caffeine, and Codeine?

• If you have an allergy to butalbital, acetaminophen, caffeine, codeine, or any other part of butalbital, acetaminophen, caffeine, and codeine.
• If you are allergic to butalbital, acetaminophen, caffeine, and codeine; any part of butalbital, acetaminophen, caffeine, and codeine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: Lung or breathing problems like asthma, trouble breathing, or sleep apnea; high levels of carbon dioxide in the blood; or stomach or bowel block or narrowing.
• If you have porphyria.
• If you have taken certain drugs for depression or Parkinson's disease in the last 14 days. This includes isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline. Very high blood pressure may happen.
• If you are taking any of these drugs: Linezolid or methylene blue.
• If you are taking any of these drugs: Buprenorphine, butorphanol, nalbuphine, or pentazocine.
• If you have been told by your doctor that you are a rapid metabolizer of some drugs.
• If you are breast-feeding. Do not breast-feed while you take butalbital, acetaminophen, caffeine, and codeine.

This is not a list of all drugs or health problems that interact with butalbital, acetaminophen, caffeine, and codeine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take butalbital, acetaminophen, caffeine, and codeine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Butalbital, Acetaminophen, Caffeine, and Codeine?

• Tell all of your health care providers that you take butalbital, acetaminophen, caffeine, and codeine. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how butalbital, acetaminophen, caffeine, and codeine affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• Avoid taking other products that have acetaminophen in them. Check labels closely. Too much acetaminophen may cause liver problems.
• Follow the directions exactly. Do not take more acetaminophen in a day than directed. If you do not know how much acetaminophen you can take in a day, ask your doctor or pharmacist. Some people may take up to 4,000 mg (milligrams) in a day if told to do so by the doctor. Some people (like people with liver problems and children) should take less acetaminophen. Call your doctor right away if you have taken too much acetaminophen in a day, even if you feel well.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take butalbital, acetaminophen, caffeine, and codeine.
• Do not take butalbital, acetaminophen, caffeine, and codeine with other strong pain drugs or if you are using a pain patch without talking to your doctor first.
• Be careful if you have G6PD deficiency. Anemia may happen.
• Limit your use of caffeine (for example, tea, coffee, cola) and chocolate. Use with butalbital, acetaminophen, caffeine, and codeine may cause nervousness, shakiness, and a fast heartbeat.
• This medicine may raise the chance of seizures in some people, including people who have had seizures in the past. Talk to your doctor to see if you have a greater chance of seizures while taking butalbital, acetaminophen, caffeine, and codeine.
• Allergic reactions have happened with butalbital, acetaminophen, caffeine, and codeine. Rarely, some reactions can be very bad or life-threatening. Talk with the doctor.
• Long-term use of an opioid drug may lead to lower sex hormone levels. Call your doctor if you have a lowered interest in sex, fertility problems, no menstrual period (women), or change in sex ability (men).
• Taking an opioid drug like butalbital, acetaminophen, caffeine, and codeine may lead to a rare but very bad adrenal gland problem. Call your doctor right away if you have very bad dizziness or passing out, very bad upset stomach or throwing up, or if you feel less hungry, very tired, or very weak.
• If you are 65 or older, use butalbital, acetaminophen, caffeine, and codeine with care. You could have more side effects.
• The chance of very bad side effects may be higher in children. This may be more likely to happen in children who have breathing problems. Deadly breathing problems have happened with the use of codeine in some children. Talk with the doctor.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking butalbital, acetaminophen, caffeine, and codeine, call your doctor right away.

How is this medicine (Butalbital, Acetaminophen, Caffeine, and Codeine) best taken?

Use butalbital, acetaminophen, caffeine, and codeine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food. Take with food if it causes an upset stomach.
• Drink lots of noncaffeine liquids unless told to drink less liquid by your doctor.
• Keep a diary of your headaches.
• If you drink grapefruit juice or eat grapefruit often, talk with your doctor.
• You will be watched closely to make sure you do not misuse, abuse, or become addicted to butalbital, acetaminophen, caffeine, and codeine.
• If you have been taking butalbital, acetaminophen, caffeine, and codeine for a long time or at high doses, it may not work as well and you may need higher doses to get the same effect. This is known as tolerance. Call your doctor if butalbital, acetaminophen, caffeine, and codeine stops working well. Do not take more than ordered.
• Long-term or regular use of opioid drugs like butalbital, acetaminophen, caffeine, and codeine may lead to dependence. Lowering the dose or stopping butalbital, acetaminophen, caffeine, and codeine all of a sudden may cause a greater risk of withdrawal or other severe problems. Talk to your doctor before you lower the dose or stop butalbital, acetaminophen, caffeine, and codeine. You will need to follow your doctor’s instructions. Tell your doctor if you have more pain, mood changes, thoughts of suicide, or any other bad effects.

What do I do if I miss a dose?

• If you take butalbital, acetaminophen, caffeine, and codeine on a regular basis, take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• Many times butalbital, acetaminophen, caffeine, and codeine is taken on an as needed basis. Do not take more often than told by the doctor.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Very bad dizziness or passing out.
• Feeling confused.
• Severe constipation or stomach pain. These may be signs of a severe bowel problem.
• Fever, chills, or sore throat; any unexplained bruising or bleeding; or feeling very tired or weak.
• Mood changes.
• Seizures.
• Noisy breathing.
• Chest pain or pressure or a fast heartbeat.
• Shakiness.
• Feeling sluggish, drunk, or out of sorts.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
• A severe and sometimes deadly problem called serotonin syndrome may happen if you take butalbital, acetaminophen, caffeine, and codeine with certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; severe diarrhea, upset stomach, or throwing up; or severe headache.

What are some other side effects of Butalbital, Acetaminophen, Caffeine, and Codeine?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Stomach pain.
• Upset stomach or throwing up.
• Constipation.
• Feeling dizzy, sleepy, tired, or weak.
• Headache.
• Feeling nervous and excitable.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Butalbital, Acetaminophen, Caffeine, and Codeine?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time butalbital, acetaminophen, caffeine, and codeine is refilled. If you have any questions about butalbital, acetaminophen, caffeine, and codeine, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.