Uses of Ascomp-Codeine:

• It is used to treat tension headaches.

What do I need to tell my doctor BEFORE I take Ascomp-Codeine?

• If you are allergic to Ascomp-Codeine (butalbital, aspirin, caffeine, and codeine); any part of Ascomp-Codeine (butalbital, aspirin, caffeine, and codeine); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have gotten nasal polyps or had swelling of the mouth, face, lips, tongue, or throat; unusual hoarseness; or trouble breathing with aspirin or NSAID use.
• 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 hemophilia.
• If you have Reye's syndrome.
• If you have kidney disease.
• 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 are taking probenecid.
• If you are taking any other NSAID.
• If you have been told by your doctor that you are a rapid metabolizer of some drugs.
• If you are pregnant or may be pregnant. Do not take Ascomp-Codeine (butalbital, aspirin, caffeine, and codeine) if you are in the third trimester of pregnancy. You may also need to avoid Ascomp-Codeine (butalbital, aspirin, caffeine, and codeine) at other times during pregnancy. Talk with your doctor to see when you need to avoid taking Ascomp-Codeine (butalbital, aspirin, caffeine, and codeine) during pregnancy.
• If you are breast-feeding. Do not breast-feed while you take Ascomp-Codeine (butalbital, aspirin, caffeine, and codeine).

This is not a list of all drugs or health problems that interact with Ascomp-Codeine (butalbital, aspirin, 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 Ascomp-Codeine (butalbital, aspirin, 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 Ascomp-Codeine?

• Tell all of your health care providers that you take Ascomp-Codeine (butalbital, aspirin, 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 Ascomp-Codeine (butalbital, aspirin, 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.
• You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
• If you are taking aspirin to help prevent a heart attack, talk with your doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take Ascomp-Codeine (butalbital, aspirin, caffeine, and codeine).
• Do not take Ascomp-Codeine (butalbital, aspirin, caffeine, and codeine) with other strong pain drugs or if you are using a pain patch without talking to your doctor first.
• Limit your use of caffeine (for example, tea, coffee, cola) and chocolate. Use with Ascomp-Codeine (butalbital, aspirin, caffeine, and codeine) may cause nervousness, shakiness, and a fast heartbeat.
• Taking an opioid drug like Ascomp-Codeine (butalbital, aspirin, 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.
• 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).
• 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 Ascomp-Codeine (butalbital, aspirin, caffeine, and codeine).
• If you are 65 or older, use Ascomp-Codeine (butalbital, aspirin, 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.
• Do not give to children and teenagers who have or are getting better from flu signs, chickenpox, or other viral infections due to the chance of Reye's syndrome. Reye's syndrome causes very bad problems to the brain and liver.
• 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 Ascomp-Codeine (butalbital, aspirin, caffeine, and codeine), call your doctor right away.

How is this medicine (Ascomp-Codeine) best taken?

Use Ascomp-Codeine (butalbital, aspirin, caffeine, and codeine) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take by mouth only.
• Take with or without food. Take with food if it causes an upset stomach.
• If you have been taking Ascomp-Codeine (butalbital, aspirin, 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 Ascomp-Codeine (butalbital, aspirin, caffeine, and codeine) stops working well. Do not take more than ordered.
• Long-term or regular use of opioid drugs like Ascomp-Codeine (butalbital, aspirin, caffeine, and codeine) may lead to dependence. Lowering the dose or stopping Ascomp-Codeine (butalbital, aspirin, 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 Ascomp-Codeine (butalbital, aspirin, 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 Ascomp-Codeine (butalbital, aspirin, 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 Ascomp-Codeine (butalbital, aspirin, 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.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Noisy breathing.
• Very bad dizziness or passing out.
• Feeling confused.
• Chest pain or pressure or a fast heartbeat.
• Any unexplained bruising or bleeding.
• Ringing in ears.
• Seizures.
• Severe constipation or stomach pain. These may be signs of a severe bowel problem.
• Feeling very tired or weak.
• Mood changes.
• A severe and sometimes deadly problem called serotonin syndrome may happen if you take Ascomp-Codeine (butalbital, aspirin, 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.
• Very bad stomach ulcers or bleeding can happen with Ascomp-Codeine (butalbital, aspirin, caffeine, and codeine). Taking it in high doses or for a long time, smoking, or drinking alcohol raises the chance of these side effects. Taking Ascomp-Codeine (butalbital, aspirin, caffeine, and codeine) with food will not lower the chance of these effects. Call your doctor or get medical help right away if you get very bad stomach or back pain; black, tarry, or bloody stools; throwing up blood or throw up that looks like coffee grounds; or weight gain or swelling that is not normal.

What are some other side effects of Ascomp-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:

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

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 Ascomp-Codeine?

• Store at room temperature protected from light. 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 Ascomp-Codeine (butalbital, aspirin, caffeine, and codeine) is refilled. If you have any questions about Ascomp-Codeine (butalbital, aspirin, 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.