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:
This combination medication contains a narcotic pain reliever, acetaminophen (a non-aspirin pain reliever), caffeine and butalbital. Caffeine is used to enhance pain relief, especially in certain types of headaches. Butalbital provides a calming effect. This combination medication is used to relieve moderate to severe pain.
Fioricet SIDE EFFECTS: Stomach upset, headache, blurred vision, constipation, drowsiness, dizziness or lightheadedness may occur. If any of these effects persist or worsen, inform your doctor. Notify your doctor immediately if you develop: rapid heart rate, fainting, breathing difficulties, mood changes, depression, irritability, nervousness. 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 PRECAUTIONS: Tell your doctor if you have a history of: asthma or other breathing disorders, kidney disease, liver disease, drug dependency, allergies (especially drug allergies). Use caution performing tasks requiring alertness if this medication causes you to feel drowsy or dizzy. This product contains acetaminophen. Acetaminophen may cause liver damage. Daily use of alcohol, especially when combined with acetaminophen, may increase your risk for liver damage. Check with your doctor or pharmacist for more information. To avoid dizziness and lightheadedness when rising from a seated or lying position, get up slowly. Also limit your intake of alcoholic beverages which will aggravate these effects. The elderly and children may be more susceptible to the effects of this medication. Use this with caution. This medication should be used during pregnancy only if clearly needed. Discuss the risks and benefits with your doctor. It is not known if this medication appears in breast milk. Consult your doctor before breast-feeding.
FIoricet DRUG INTERACTIONS: Tell your doctor of any over-the-counter or prescription medication you may take including: medication for depression or seizures, other narcotic pain relievers, sleeping pills, sedatives, cimetidine, quinidine. This drug may interfere with the effectiveness of birth control pills. Discuss using other methods of birth control with your doctor. Acetaminophen is an ingredient in many nonprescription products and in some combination prescription medications. Read the labels carefully before taking other pain relievers, fever reducers, or cold products to see if they also contain acetaminophen. Consult your pharmacist if you are uncertain if your other prescription or nonprescription products contain acetaminophen. (Also see adult maximum daily dose information in Side Effects section). Avoid the use of alcohol while taking this medication. Do not start or stop any medicine without doctor or pharmacist approval.
Fioricet OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include vomiting, excessive drowsiness or dizziness, slow or shallow breathing, cold or clammy skin, rapid or irregular heartbeat, seizures, loss of consciousness, severe nausea, yellowing eyes or skin, dark urine, stomach pain, extreme fatigue.
NOTES: Long-term or excessive use of narcotic analgesics may lead to dependency. It is important that you follow your dosing schedule as prescribed. If the dose prescribed does not provide pain relief, contact your doctor.
MISSED DOSE: If you miss a dose, take it as soon as remembered; do not take it if it is near the time for the next dose, instead, skip the missed dose and resume your usual dosing schedule. Do not “double-up” the dose to catch up.
STORAGE: Store at room temperature between 59 and 86 degrees F (15 and 30 degrees C) away from heat and light. Do not store in the bathroom.
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 is the most important information I should know about acetaminophen, butalbital, and 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.
