Acetaminophen, Butalbital, and Caffeine

Taking too much acetaminophen (found in this combination preparation) can cause liver damage, sometimes serious enough to require liver transplantation or cause death. Do not take more than 4,000 mg of acetaminophen per day. If you need to take more than one product that contains acetaminophen, calculate the total amount of acetaminophen you are taking. Ask your doctor or pharmacist to help you.

Tell your doctor if you have or have ever had liver disease.

Acetaminophen, butalbital, and caffeine is used to relieve tension headaches. Acetaminophen, butalbital, and caffeine is in a class of medications called combination analgesics (pain relievers). This medication works by decreasing pain, slowing the nervous system, and narrowing swollen blood vessels in the head to provide tension headache relief.

Acetaminophen, butalbital, and caffeine comes as a capsule, a tablet, and a solution (liquid) to take by mouth.Take every 4 hours as needed.

Take acetaminophen, butalbital, and caffeine exactly as directed. Do not take more than 6 tablets, capsules, or tablespoonsful in 1 day. If you think that you need more to relieve your symptoms, call your doctor.

This medication can be habit-forming. Do not take a larger dose, take it more often, or for a longer period of time than prescribed by your doctor.

If you are taking acetaminophen, butalbital, and caffeine oral solution, do not use a household spoon to measure your dose. Use the measuring cup or spoon that came with the medication or use a spoon that is made especially for measuring medication. Ask your pharmacist if you have any question about how much medication you should take or how to use the dosing cup or syringe.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking acetaminophen, butalbital, and caffeine,

• tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking acetaminophen, butalbital, and caffeine. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor or pharmacist if you are taking the following medications or have stopped taking them within the past two weeks: isocarboxazid, linezolid, methylene blue, phenelzine, selegiline, and tranylcypromine.
• you should know the following nonprescription or herbal products may interact with the combination of acetaminophen, butalbital, and caffeine: some medications for allergy (diphenhydramine, chlorpheniramine), multivitamins, and medications for sleep. Be sure to let your doctor and pharmacist know that you are taking these medications when taking the combination of acetaminophen, butalbital, and caffeine. Do not start any of these medications while taking the combination of acetaminophen, butalbital, and caffeine without discussing with your healthcare provider.
• tell your doctor if you have porphyria. Your doctor may tell you not to take acetaminophen, butalbital, and caffeine.
• tell your doctor if you have or have ever had stomach or kidney problems or a history of depression or drug abuse.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking acetaminophen, butalbital, and caffeine, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking the combination of aspirin, butalbital, and caffeine.
• you should know that this drug may make you drowsy. Do not drive a car or operate machinery until you know how this drug affects you.
• ask your doctor about the safe use of alcoholic beverages while you are taking acetaminophen, butalbital, and caffeine. Alcohol can make the side effects from acetaminophen, butalbital, and caffeine worse.

Unless your doctor tells you otherwise, continue your normal diet.

This medication is usually taken as needed. If your doctor has told you to take acetaminophen, butalbital, and caffeine regularly, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Acetaminophen, butalbital, and caffeine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• drowsiness
• nausea
• vomiting
• stomach pain
• lightheadedness
• dizziness
• confusion

Some side effects can be serious. If you experience any of these symptoms stop taking this medicine and call your doctor immediately or get emergency medical treatment:

• rash
• hives
• itching
• peeling, blistering skin
• difficulty breathing or swallowing
• swelling of the face, throat, tongue, lips, or eyes

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature, away from excess heat and moisture (not in the bathroom).

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• drowsiness
• confusion
• coma
• irregular or slowed breathing
• nausea
• vomiting
• loss of appetite
• unusual bleeding or bruising
• sweating
• pain in upper right part of the stomach
• yellowing of the skin or eyes
• difficulty falling asleep or staying asleep
• restlessness
• rapid or pounding heartbeat
• tremor
• confusion

Keep all appointments with your doctor.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking acetaminophen, butalbital, and caffeine.

Do not let anyone else take your medication. This medication is a controlled substance. Prescriptions may be refilled only a limited number of times; ask your pharmacist if you have any questions.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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