Fioricet 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. 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.  

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) of acetaminophen per day. 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.  

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

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:  

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

apap

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

caffeine

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 ” on one side, and a three-head profile “” on other side. Bottles of 100 (NDC 52544-957-01) and 500 (NDC 52544-957-05).  

Storage

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

What is 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.  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.  

How should I take acetaminophen, butalbital, and caffeine?

 Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. 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.  

An overdose of acetaminophen can cause serious harm. The maximum amount of acetaminophen for adults is 1 gram (1000 mg) per dose and 4 grams (4000 mg) per day. Taking more acetaminophen could cause damage to your liver. One tablet may contain up to 750 mg of acetaminophen. Know the amount of acetaminophen in the specific product you are taking.  

Store this medication at room temperature away from moisture and heat.  

Keep track of how much medicine has been used from each new bottle. Butalbital is a drug of abuse and you should be aware if any person in the household is using this 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. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.  

What happens if I overdose?

 Seek emergency medical attention if you think you have used too much of this medicine.  Overdose symptoms may include insomnia, restlessness, tremor, dizziness, drowsiness, nausea, vomiting, diarrhea, stomach pain, loss of appetite, 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.  

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.  

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) of acetaminophen per day.  

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.  

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? 

The following drugs can interact with acetaminophen, butalbital, and caffeine. Tell your doctor if you are using any of these:  

• an antibiotic;
• a blood thinner such as warfarin (Coumadin);
• isoniazid;
• zidovudine (Retrovir, AZT);
• seizure medication such as phenytoin (Dilantin) or phenobarbital (Luminal, Solfoton);
• gout medications such as probenecid (Benemid) or sulfinpyrazone;
• an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate);
• steroids such as prednisone, fluticasone (Advair), mometasone (Asmanex, Nasonex), dexamethasone (Decadron, Hexadrol) and others; or
• an antidepressant such as amitriptyline (Elavil, Etrafon), clomipramine (Anafranil), desipramine (Norpramin), imipramine (Janimine, Tofranil), and others.