acetaminophen, butalbital, and caffeine (Alagesic, Anolor 300, Dolgic LQ, Dolgic Plus, Esgic, Esgic-

Brand Names: Alagesic, Anolor 300, Dolgic LQ, Dolgic Plus, Esgic, Esgic-Plus, Fioricet, Geone, Margesic, Medigesic, Repan, Zebutal

Generic Name: acetaminophen, butalbital, and caffeine (Pronunciation: a SEET a MIN oh fen, bue TAL bi tal, and KAF een)

What is acetaminophen, butalbital, and caffeine (Alagesic, Anolor 300, Dolgic LQ, Dolgic Plus, Esgic, Esgic-Plus, Fioricet, Geone, Margesic, Medigesic, Repan, Zebutal)?

Acetaminophen is a pain reliever and fever reducer.

Butalbital is in a group of drugs called barbiturates. It relaxes muscle contractions involved in a tension headache.

Caffeine is a central nervous system stimulant. It relaxes muscle contractions in blood vessels to improve blood flow.

The combination of acetaminophen, butalbital, and caffeine is used to treat tension headaches that are caused by muscle contractions.

Acetaminophen, butalbital, and caffeine may also be used for purposes not listed in this medication guide.

APAP-Butalb-Caffeine 325-50-40 mg Tab-MAL

round, white, imprinted with M, 970

APAP-Butalbital-Caffeine 325-50-40 mg-WAT

oblong, white, imprinted with 3416, WPI

APAP-Butalbital-Caffeine Cap-QUA

capsule, white, imprinted with 59743, 004

APAP-BUT-CAFF-QUA

oblong, white, imprinted with MIA 110

Esgic Cap

capsule, green/white, imprinted with LOGO, 535-12

Esgic Plus

oblong, white, imprinted with FOREST, 678

Fioricet

round, blue, imprinted with FIORICET S, LOGO

Fiorpap

round, blue, imprinted with CP, 275

What are the possible side effects of acetaminophen, butalbital, and caffeine?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • fast, pounding, or uneven heartbeat;
  • feeling light-headed or short of breath;
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
  • easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms.

Less serious side effects may include:

  • drowsiness;
  • dizziness, confusion or lightheadedness;
  • dry mouth;
  • nausea, vomiting, stomach pain, loss of appetite;
  • feeling anxious or jittery;
  • drunk feeling; or
  • headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about acetaminophen, butalbital, and caffeine?

Do not use acetaminophen, butalbital, and caffeine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Tell your doctor if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen.

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death.

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.

What should I discuss with my healthcare provider before taking acetaminophen, butalbital, and caffeine?

Do not use acetaminophen, butalbital, and caffeine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Tell your doctor if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen.

You should not take this medication if you are allergic to acetaminophen, butalbital, or caffeine, or if you have porphyria.

To make sure you can safely take acetaminophen, butalbital, and caffeine, tell your doctor if you have any of these other conditions:

Butalbital may be habit forming and should be used only by the person it was prescribed for. Never share this medication with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

FDA pregnancy category C. It is not known whether acetaminophen, butalbital, and caffeine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Acetaminophen, butalbital, and caffeine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take acetaminophen, butalbital, and caffeine?

Take exactly as prescribed. Never take acetaminophen, butalbital, and caffeine in larger amounts, or for longer than recommended by your doctor. An overdose of this medication can damage your liver or cause death. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Take the medicine with food or milk if it upsets your stomach.

Store at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Butalbital is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

What happens if I miss a dose?

Since this medication is usually taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Overdose symptoms may also include insomnia, restlessness, tremor, dizziness, drowsiness, diarrhea, increased sweating, shallow breathing, confusion, uneven heartbeats, seizure (convulsions), or coma.

What should I avoid while taking acetaminophen, butalbital, and caffeine?

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

While you are taking this medication, avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice.

What other drugs will affect acetaminophen, butalbital, and caffeine?

Tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by butalbital.

Tell your doctor about all other medicines you use, especially:

This list is not complete and other drugs may interact with acetaminophen, butalbital, and caffeine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about acetaminophen, butalbital, and caffeine.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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