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. Be aware that you should not take more than 4,000 mg of acetaminophen per day. You might accidentally take too much acetaminophen if you do not follow the directions on the prescription or package label carefully, or if you take more than one product that contains acetaminophen. If you need to take more than one product that contains acetaminophen, it may be difficult for you to 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 is in a class of medications called analgesics (pain relievers). It works by changing the way the body senses pain. Butalbital is in a class of medications called barbiturates. It works by having a relaxing effect on the brain and central nervous system (CNS). Caffeine is a CNS stimulant. It works by changing the amounts of certain natural substances in the brain.

The combination of acetaminophen, butalbital, and caffeine comes as a capsule and tablet to take by mouth. It usually is taken every 4 hours as needed. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take acetaminophen, butalbital, and caffeine exactly as directed. Do not take more than six tablets or capsules 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.

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 and pharmacist if you are allergic to acetaminophen, butalbital, caffeine, any other drugs, or any ingredient in acetaminophen, butalbital, and caffeine capsules or tablets. Ask your pharmacist for a list of the ingredients.
• 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 (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), selegiline (Emsam, Zelapar), and tranylcypromine (Parnate).
• tell your doctor if you have porphyria. Your doctor will probably tell you not to take acetaminophen, butalbital, and caffeine.
• tell your doctor if you have or have ever had stomach or kidney problems.
• 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.
• 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

If you experience any of the following symptoms, call your doctor immediately:

• 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).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

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 the following:

• 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.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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