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
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What is Fioricet?
• Acetaminophen is a pain reliever and fever reducer.
• Butalbital is in a class of drugs called barbiturates that slow down your central nervous system (brain and nerve impulses) causing relaxation.
• Caffeine is believed to constrict dilated blood vessels that may contribute to tension headaches.
• Together, acetaminophen, butalbital, and caffeine are used to relieve complex tension (muscle contraction) headaches although precisely how it works is unknown.
• Fioricet may also be used for purposes other than those listed in this medication guide.
What should I discuss with my healthcare provider before taking Fioricet?
• This medication is habit forming and should only be used under close supervision. Take this drug only for as long as it is prescribed , in the amounts it is prescribed, and no more frequently than prescribed.
• Do not take Fioricet without first talking to your doctor if you drink more than three alcoholic beverages per day or if you have had alcoholic liver disease. You may not be able to take acetaminophen and butalbital, or you may require a lower dose.
• Do not take Fioricet if you have porphyria.
• Before taking this medication, tell your doctor if you have
• kidney disease, or
• liver disease.
• You may not be able to take Fioricet, or you may require a lower dose or special monitoring during treatment if you have any of the conditions listed above.
• This drug combination is in the FDA pregnancy category C. This means that its effects on an unborn baby are not known. Do not take this medication without first talking to your doctor if you are pregnant.
• This drug combination passes into breast milk and may harm a nursing infant. Do not take this medication without first talking to your doctor if you are breast-feeding a baby.
• Fioricet has not been approved for use in children younger than 12 years of age.
How should I take Fioricet?
• Take Fioricet exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
• Take each dose with a full glass of water.
• Take Fioricet with food or milk if it upsets your stomach.
• Never take more Fioricet than is prescribed for you. If your pain is not being adequately treated, talk to your doctor.
• Store Fioricet at room temperature away from moisture and heat.
What happens if I miss a dose?
• Take the missed dose as soon as you remember. Do not take a double dose of this medication. Wait the prescribed amount of time before taking your next dose.
What happens if I overdose?
• Seek emergency medical attention.
• Symptoms of an Fioricet overdose include insomnia, restlessness, tremor, nausea, vomiting, diarrhea, abdominal pain, sweating, seizures, drowsiness, decreased breathing, dizziness or fainting, confusion, an irregular heartbeat, and coma.
What should I avoid while taking Fioricet?
• Use caution when driving, operating machinery, or performing other hazardous activities. Butalbital will cause drowsiness or dizziness. If you experience drowsiness or dizziness, avoid these activities.
• Avoid sleeping pills, antihistamines, sedatives, and tranquilizers except under the supervision of your doctor. These may also make you drowsy.
• Avoid alcohol. Alcohol taken during therapy with acetaminophen and butalbital can be very damaging to your liver and can increase drowsiness and dizziness.
• Check the acetaminophen content of other over-the-counter and prescription products while taking this medication. You should not exceed 4 grams (4000 mg) of acetaminophen per day.
• Avoid taking too much caffeine. Check the caffeine content of other over-the-counter and prescription products as well as beverages (coffee, tea, and colas) while taking this medication
What are the possible side effects of Fioricet?
• If you experience any of the following serious side effects, stop taking Fioricet and seek emergency medical attention:
• an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
• slow, weak breathing;
• liver damage (yellowing of the skin or eyes, nausea, abdominal pain or discomfort, unusual bleeding or bruising, severe fatigue);
• blood problems (easy or unusual bleeding or bruising); or
• low blood sugar (fatigue, increased hunger or thirst, dizziness, or fainting).
• These side effects are very rare and are not likely to occur during proper treatment with acetaminophen and caffeine. If you experience any unusual reactions, stop taking this medicine and seek the advice of your doctor.
• Other, less serious side effects may be more likely to occur. Continue to take Fioricet and talk to your doctor if you experience
• dizziness,, confusion or lightheadedness;
• shortness of breath;
• dry mouth;
• nausea, vomiting, abdominal pain, or decreased appetite;
• tiredness, leg pain, or muscle weakness;
• agitation, irritability, nervousness, anxiety or excitability;
• rash or itching;
• feeling of intoxication;
• headache; or
• Butalbital may be habit forming.
• Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.
What other drugs will affect Fioricet?
• Do not take Fioricet if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. Dangerous side effects could result.
• Acetaminophen and butalbital may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, antihistamines, sedatives (used to treat insomnia), other pain relievers, anxiety medicines, and muscle relaxants. Tell your doctor about all medicines that you are taking, and do not take any medicine unless your doctor approves.
• Many other medicines contain acetaminophen, especially over-the-counter pain, fever, cold, and allergy medications. Too much acetaminophen can be very dangerous.
• Drugs other than those listed here may also interact with Fioricet. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.
Where can I get more information?
• Your pharmacist has additional information about Fioricet written for health professionals that you may read.
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). Bottles of 100 are supplied with child-resistant closures.
Store below 30°C (86°F); dispense in a tight container.
Before taking this medication, tell your doctor or pharmacist if you are allergic to acetaminophen, caffeine, or butalbital; or to other barbiturates (such as phenobarbital) or xanthine derivatives (such as theophylline); or if you have any other allergies.
This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: severe breathing problems (such as bronchopneumonia), a certain enzyme disorder (porphyria), liver disease, kidney disease, personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol), mental/mood disorders, abdominal/stomach problems (such as stomach ulcer).
This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). Liquid products may contain alcohol, sugar and/or aspartame.
Caution is advised if you have diabetes, alcohol dependence, liver disease, phenylketonuria (PKU), or any other condition that requires you to limit/avoid these substances in your diet. Ask your doctor or pharmacist about using this product safely.
Before having surgery or certain medical procedures (such as a heart stress test or a procedure to restore a normal heart rhythm if you have an unusually fast heartbeat), tell your doctor or dentist that you use this medication and about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Older adults may be more sensitive to the side effects of this drug, especially drowsiness and trouble falling asleep. These side effects can increase the risk of falling. During pregnancy, this medication should be used only when clearly needed.
Using it for long periods or in high doses near the expected delivery date is not recommended because of possible harm to the unborn baby. Discuss the risks and benefits with your doctor. Infants born to mothers who have used this medication for an extended time may have withdrawal symptoms such as irritability, abnormal/persistent crying, vomiting, seizures, or diarrhea. Tell your doctor right away if you notice any of these symptoms in your newborn.
This drug passes into breast milk and could have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.
Store at room temperature away from light and moisture. Do not store in the bathroom.
Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Fioricet Drug Interaction
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions.
Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.
Some products that may interact with this drug include: darunavir, sodium oxybate, drugs affecting liver enzymes that remove this medication from your body (such as macrolide antibiotics including erythromycin, cimetidine, disulfiram, valproic acid, fluvoxamine, MAO inhibitors including isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine), isoniazid, lithium, phenothiazines (such as chlorpromazine).
This drug can speed up the removal of other drugs from your body by affecting certain liver enzymes. These affected drugs include “blood thinners” (such as warfarin), doxycycline, estrogen, felodipine, quinidine, theophylline, certain beta blockers such as metoprolol, corticosteroids such as prednisone.
Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), other drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).
Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain caffeine or ingredients that cause drowsiness. Also keep in mind that certain beverages (such as coffee, colas, tea, energy drinks) contain caffeine. Ask your pharmacist about using those products safely.
This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use additional reliable birth control methods while using this medication.
Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well. This medication may interfere with certain medical/laboratory tests, possibly causing false test results.
Make sure laboratory personnel and all your doctors know you use this drug.
Fioricet Butalbital Overdose
If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222.
Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe drowsiness, slow/shallow breathing, severe dizziness, nausea, vomiting, loss of appetite, sweating, stomach/abdominal pain, extreme tiredness, yellowing eyes/skin, dark urine.