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 other purposes not listed in this medication guide.

What is the most important information I should know about Apap/Butalbital/Caffeine?

Do not use this medication if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take acetaminophen, butalbital, and caffeine before the MAO inhibitor has cleared from your body.

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

Do not use any other cold, allergy, pain, or sleep medication without first asking your doctor or pharmacist. Acetaminophen (sometimes abbreviated as "APAP") is contained in many combination medicines. If you use certain products together you may accidentally use too much acetaminophen. Read the label of any other medicine you are using to see if it contains acetaminophen or APAP.

Avoid drinking alcohol. It can increase the risk of liver damage while you are taking acetaminophen. If you drink more than three alcoholic beverages per day, do not take acetaminophen without your doctor's advice, and never take more than 2 grams (2000 mg) per day.

What should I discuss with my healthcare provider before taking Apap/Butalbital/Caffeine?

Butalbital may be habit-forming and should be used only by the person it was prescribed for. This medication should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

Do not take this medication without first talking to your doctor if you drink more than three alcoholic beverages per day or if you have had alcoholic liver disease (cirrhosis). You may not be able to take medication that contains acetaminophen.

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

Before using acetaminophen, butalbital, and caffeine, tell your doctor if you are allergic to any drugs, or if you have:

• kidney disease,
• liver disease; or
• a history of mental illness or suicidal thoughts

If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.

FDA pregnancy category C. It is not known whether acetaminophen, butalbital, and caffeine is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment.

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.

Photos of Apap/Butalbital/Caffeine

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Butalbital and Acetaminophen Description

Butalbital and Acetaminophen is supplied in tablet form for oral administration.

Butalbital (5-allyl-5-isobutylbarbituric acid), a slightly bitter, white, odorless, crystalline powder, is a short to intermediate-acting barbiturate. It has the following structural formula:

C11H16N2O3                          MW = 224.26

Acetaminophen (4’-hydroxyacetanilide), a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:

C8H9NO2                            MW = 151.17

Each Butapap tablet contains:

Butalbital …………………………………………….50 mg
         Warning: May be habit forming.
Acetaminophen ……………………………………...325 mg

In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid.

GENERIC NAME: BUTALBITAL/ACETAMINOPHEN/CAFFEINE - ORAL (byou-TAL-bih-tall/uh-seet-uh-MEE-no-fen/kaff-EEN)

BRAND NAME(S): Esgic, Fioricet

USES: This medication is a pain reliever and sedative. It is used to relieve mild to moderate pain and tension headaches.

OTHER USES: This medication may also be used to treat migraine headaches.

HOW TO USE: To prevent upset stomach, take this medication with food or milk. Pain medications work best if they are used as the first signs of pain (or first signs of migraine) occur. If you wait until the pain has significantly worsened, the pain medicine may not work as well. Take this as prescribed. Do not increase your dose or take it more frequently without your doctor's approval. This medication contains acetaminophen. Do not take more acetaminophen than recommended (see Side Effects section).

SIDE EFFECTS: May cause lightheadedness, dizziness, drowsiness, stomach upset, nausea, and sleeping disturbances the first few days as your body adjusts to the medication. If these symptoms persist or become bothersome, inform your doctor. Notify your doctor immediately if you develop: a rapid/ irregular heartbeat. If you do not have liver problems, the adult maximum dose of acetaminophen is 4 grams per day (4000 milligrams). If you take more than the maximum daily amount, it may cause serious (possibly fatal) liver disease. Tell your doctor immediately if you have any of the following symptoms of liver damage: severe nausea, yellowing eyes or skin, dark urine, stomach pain, extreme fatigue. An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching, swelling, severe dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

Fioricet® (Butalbital, Acetaminophen, and Caffeine Tablets USP) is supplied in tablet form for oral administration.

Each tablet contains the following active ingredients:
butalbital USP . . . . . . . . . . . .50 mg
acetaminophen USP . . . . . . 325 mg
caffeine USP . . . . . . . . . . . . .40 mg

Inactive Ingredients: crospovidone, FD&C Blue #1, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid.

Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to intermediate-acting barbiturate. It has the following structural formula:

C₁₁H₁₆N₂O₃          Mol. wt. 224.26

Acetaminophen (4´-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:

C₈H₉NO₂              Mol. wt. 151.17

Caffeine (1,3,7-trimethylxanthine), is a central nervous system stimulant. It has the following structural formula:

C₈H₁₀N₄O₂          Mol. wt. 194.19

Butalbital, structure presents as 5-allyl-5-isobutylbarbituric acid, is a barbiturate with an intermediate duration of action. It has the same chemical formula as talbutal but a different structure. Butalbital is often combined with other medications, such as paracetamol (acetaminophen) or aspirin, and is commonly prescribed for the treatment of pain and headache. The various formulations combined with codeine are FDA approved for the treatment of tension headaches.

Combinations include:

• Butalbital and paracetamol (acetaminophen) (trade names: Axocet, Bucet, Bupap, Cephadyn, Dolgic, Phrenilin, Phrenilin Forte, Sedapap)
• Butalbital, paracetamol (acetaminophen), and caffeine (trade names: Fioricet, Esgic, Esgic-Plus)
• Butalbital and aspirin (trade name: Axotal)
• Butalbital, aspirin, and caffeine (trade names Fiorinal, Fiormor, Fiortal, Fortabs, Laniroif)
• Butalbital, paracetamol (acetaminophen), caffeine, and codeine phosphate (Fioricet #3 with Codeine)
• Butalbital, aspirin, caffeine, and codeine phosphate (trade name: Fiorinal #3 with Codeine)

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