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Butalbital, Acetaminophen Oral capsule

What is this medicine?

ACETAMINOPHEN; BUTALBITAL (a set a MEE noe fen; byoo TAL bi tal) is a pain reliever. It is used to treat tension headaches.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

  • drink more than 3 alcohol containing drinks per day

  • drug abuse or addiction

  • kidney disease

  • liver disease

  • porphyria

  • an unusual or allergic reaction to acetaminophen, butalbital or other barbiturates, other medicines, foods, dyes, or preservatives

  • pregnant or trying to get pregnant

  • breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take it with or without food. If it upsets your stomach, take it with food. Take your medicine at regular intervals. Do not take your medicine more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 12 years old for selected conditions, precautions do apply.

Patients over 65 years old may have a stronger reaction and need a smaller dose.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

  • alcohol

This medicine may also interact with the following medications:

  • antihistamines for allergy, cough and cold

  • any medicine that contains acetaminophen

  • barbiturates like phenobarbital

  • female hormones, including contraceptive or birth control pills

  • MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate

  • medicines for depression, anxiety, or psychotic disturbances

  • medicines for pain

  • medicines for sleep

  • muscle relaxants

  • other narcotic medicines

  • warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Tell your doctor or health care professional if your pain does not go away, if it gets worse, or if you have new or a different type of pain. You may develop tolerance to the medicine. Tolerance means that you will need a higher dose of the medicine for pain relief. Tolerance is normal and is expected if you take the medicine for a long time.

Do not suddenly stop taking your medicine because you may develop a severe reaction. Your body becomes used to the medicine. This does NOT mean you are addicted. Addiction is a behavior related to getting and using a drug for a non-medical reason. If you have pain, you have a medical reason to take pain medicine. Your doctor will tell you how much medicine to take. If your doctor wants you to stop the medicine, the dose will be slowly lowered over time to avoid any side effects.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

Do not take other medicines that contain acetaminophen with this medicine. Always read labels carefully. If you have questions, ask your doctor or pharmacist.

If you take too much acetaminophen get medical help right away. Too much acetaminophen can be very dangerous and cause liver damage. Even if you do not have symptoms, it is important to get help right away.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

  • breathing problems

  • confusion

  • depression or excitement

  • fast, irregular heartbeat

  • feeling faint or lightheaded

  • fever

  • redness, blistering, peeling or loosening of the skin, including inside the mouth

  • seizure

  • unusual bleeding, bruising

  • unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • constipation

  • drowsy, dizzy

  • dry mouth

  • headache

  • nausea, vomiting

  • stomach pain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children. This medicine can be abused. Keep your medicine in a safe place to protect it from theft. Do not share this medicine with anyone. Selling or giving away this medicine is dangerous and against the law.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Keep your medicine container closed tightly. Throw away any unused medicine after the expiration date.


Butalbital, Acetaminophen Oral tablet

What is this medicine?

ACETAMINOPHEN; BUTALBITAL (a set a MEE noe fen; byoo TAL bi tal) is a pain reliever. It is used to treat tension headaches.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

  • drink more than 3 alcohol containing drinks per day

  • drug abuse or addiction

  • kidney disease

  • liver disease

  • porphyria

  • an unusual or allergic reaction to acetaminophen, butalbital or other barbiturates, other medicines, foods, dyes, or preservatives

  • pregnant or trying to get pregnant

  • breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take it with or without food. If it upsets your stomach, take it with food. Take your medicine at regular intervals. Do not take your medicine more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 12 years old for selected conditions, precautions do apply.

Patients over 65 years old may have a stronger reaction and need a smaller dose.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

  • alcohol

This medicine may also interact with the following medications:

  • antihistamines for allergy, cough and cold

  • any medicine that contains acetaminophen

  • barbiturates like phenobarbital

  • female hormones, including contraceptive or birth control pills

  • MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate

  • medicines for depression, anxiety, or psychotic disturbances

  • medicines for pain

  • medicines for sleep

  • muscle relaxants

  • other narcotic medicines

  • warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Tell your doctor or health care professional if your pain does not go away, if it gets worse, or if you have new or a different type of pain. You may develop tolerance to the medicine. Tolerance means that you will need a higher dose of the medicine for pain relief. Tolerance is normal and is expected if you take the medicine for a long time.

Do not suddenly stop taking your medicine because you may develop a severe reaction. Your body becomes used to the medicine. This does NOT mean you are addicted. Addiction is a behavior related to getting and using a drug for a non-medical reason. If you have pain, you have a medical reason to take pain medicine. Your doctor will tell you how much medicine to take. If your doctor wants you to stop the medicine, the dose will be slowly lowered over time to avoid any side effects.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

Do not take other medicines that contain acetaminophen with this medicine. Always read labels carefully. If you have questions, ask your doctor or pharmacist.

If you take too much acetaminophen get medical help right away. Too much acetaminophen can be very dangerous and cause liver damage. Even if you do not have symptoms, it is important to get help right away.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

  • breathing problems

  • confusion

  • depression or excitement

  • fast, irregular heartbeat

  • feeling faint or lightheaded

  • fever

  • redness, blistering, peeling or loosening of the skin, including inside the mouth

  • seizure

  • unusual bleeding, bruising

  • unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • constipation

  • drowsy, dizzy

  • dry mouth

  • headache

  • nausea, vomiting

  • stomach pain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children. This medicine can be abused. Keep your medicine in a safe place to protect it from theft. Do not share this medicine with anyone. Selling or giving away this medicine is dangerous and against the law.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Keep your medicine container closed tightly. Throw away any unused medicine after the expiration date.