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The generic names of Fioricet are acetaminophen, caffeine and butalbital. This medicine contains a mixture of butalbital, caffeine and acetaminophen. Acetaminophen is best for giving a relief from pain and also reduces fever. Butalbital falls under the group of drugs known as barbiturates. This helps in relaxing the contractions of muscles caused due to the tension headache. The other ingredient, Caffeine is regarded as a stimulant for the central nervous system. It helps in relaxing the contraction of muscles in the blood vessels for improving the flow of blood.

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 andantipyretic. 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

Fioricet contains a combination of acetaminophen, butalbital, and caffeine. 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.

Fioricet is used to treat tension headaches that are caused by muscle contractions.

Fioricet may also be used for purposes not listed in this medication guide.

Important information about Fioricet

Do not use Fioricet 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 Fioricet 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 Fioricet due to the acetaminophen component.

Before taking Fioricet

Do not use Fioricet 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 Fioricet if you are allergic to acetaminophen, butalbital, or caffeine, or if you have porphyria.

To make sure you can safely take Fioricet, tell your doctor if you have any of these other conditions:

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

Butalbital may be habit forming and should be used only by the person it was prescribed for. Never share Fioricet 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 Fioricet 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 Fioricet without telling your doctor if you are breast-feeding a baby.

Fioriccet DOSAGE AND ADMINISTRATION

One or 2 tablets every 4 hours as needed. Total daily dosage should not exceed 6 tablets. Extended and repeated use of this product is not recommended because of the potential for physical dependence.

HOW Fioricet SUPPLIED

Fioricet® (Butalbital, Acetaminophen, and Caffeine Tablets USP)

Containing 50 mg butalbital, 325 mg acetaminophen, and 40 mg caffeine. Available as light-blue, speckled, round uncoated tablets, engraved “FIORICET (butalbital, acetaminophen and caffeine) ” on one side, and a three-head profile “” on other side. Bottles of 100 (NDC 52544-957-01) and 500 (NDC 52544-957-05).

Fioricet Storage

Store below 30°C (86°F); dispense in a tight container.

Fioricet side effects

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

Stop using Fioricet 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 Fioricet 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 other drugs will affect Fioricet?

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:

  • an antibiotic;
  • a blood thinner such as warfarin (Coumadin, Jantoven);
  • isoniazid (for treating tuberculosis);
  • zidovudine (Retrovir, AZT);
  • seizure medication such as phenytoin (Dilantin) or phenobarbital (Luminal, Solfoton);
  • gout medications such as probenecid (Benemid) or sulfinpyrazone;
  • steroids such as prednisone, fluticasone (Advair), mometasone (Asmanex, Nasonex), dexamethasone (Decadron, Hexadrol) and others; or
  • an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), clomipramine (Anafranil), desipramine (Norpramin), imipramine (Janimine, Tofranil), and others.

This list is not complete and other drugs may interact with Fioricet. 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.

 Fioricet Reviews:

I have suffered from severe, debilitating cervigenic migraines every few days, each lasting from 3 to 10 days. Little to no sleep at night. Tried it all; Cervical blocks, occipital blocks, facet injections, tramadol, amitriptylene, protriptylene,soma, halcion, skelaxin, flexeril, codiene, vicodin, physical therapy, deep tissue massage, bio feedback, surgery, etc. This is the only med that touchs them. It must be taken at the first hint of a migraine. In 15+ years I have never had an adiction problem. 

Since I have suffered migraines since the age of 6, I have been through a huge amount of treatments and medications to try to help with my migraines. After several stays overnight at the hospital hooked up to IV’s being given the strong medication DHE(if anyone has ever gone through taking this I am sure you understand the horricfic experience I had with it), a few years ago I finally came into contact with a doctor who had enough sense to prescribe Fioricet for me…and ever since then it has been the number one thing to relieve my pain. I understand that doctors have to take precautions when prescribing this drug, but when there are only so many days supply there, and I have to make it last a month or so it can become hard at times, especially when I have the really really bad attacks…making sure that I have enough to relieve the migraine, and enough just incase I have another attack before I am able to get a refill…so that can be extemely frustrating at times! But, overall this has been the best thing I have found, and the list of meds I have been through consists of 3 long pages. Only being 22yrs old it can be scary having to deal with these consistant headaches, but I feel that as long as I am cautious with my use of this medication and use it as I am supposed to I will make it through, and those of you who suffer from migraines and feel the same, I strongly reccomend giving Fioricet a try.

this medication has helped me with my migrains. it is a good drug but only if you really need because it is a strong medication. this drug works so good for me that their are several days that go by that i do not have to take it and i like that beacause i hate getting migrains.