Uses of Butalbital and Acetaminophen:

• It is used to treat tension headaches.

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

• If you have an allergy to butalbital, acetaminophen, or any other part of butalbital and acetaminophen.
• If you are allergic to butalbital and acetaminophen; any part of butalbital and acetaminophen; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have porphyria.
• If you are breast-feeding or plan to breast-feed.

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

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 and acetaminophen 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 and Acetaminophen?

• Tell all of your health care providers that you take butalbital and acetaminophen. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for alertness while you take butalbital and acetaminophen.
• This medicine may be habit-forming with long-term use.
• Do not take butalbital and acetaminophen for longer than you were told by your doctor.
• If you have been taking butalbital and acetaminophen 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 and acetaminophen stops working well. Do not take more than ordered.
• If you have been taking butalbital and acetaminophen on a regular basis and you stop it all of a sudden, you may have signs of withdrawal. Do not stop taking butalbital and acetaminophen all of a sudden without calling your doctor. Tell your doctor if you have any bad effects.
• Avoid taking other products that have acetaminophen in them. Check labels closely. Too much acetaminophen may cause liver problems.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take butalbital and acetaminophen.
• Avoid alcohol or other drugs and natural products that slow your actions.
• 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.
• Be careful if you have G6PD deficiency. Anemia may happen.
• If you are 65 or older, use butalbital and acetaminophen with care. You could have more side effects.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using butalbital and acetaminophen while you are pregnant.

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

Use butalbital and acetaminophen 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.

What do I do if I miss a dose?

• If you take butalbital and acetaminophen 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 and acetaminophen 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.
• Not able to pass urine or change in how much urine is passed.
• Shortness of breath.
• Slurred speech, stumbling, or feeling confused, very sleepy or dizzy, or drunk.
• 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.

What are some other side effects of Butalbital and Acetaminophen?

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:

• Dizziness.
• Feeling sleepy.
• Stomach pain.
• Upset stomach or throwing up.

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 and Acetaminophen?

• Store at room temperature.
• Protect 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.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about butalbital and acetaminophen, please talk with your doctor, nurse, 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.