Take Fioricet exactly as prescribed. Follow all directions on your prescription label.
Do not take more of this medication than recommended. An overdose can damage your liver or cause death.
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.
Store Fioricet at room temperature away from moisture and heat.
Keep track of the amount of medicine used from each new bottle. Butalbital is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.
For the treatment of the symptom complex of tension headache or occasional migraine†.
Oral dosage (products with 50 mg butalbital, 300, 325, or 500 mg acetaminophen, and caffeine 40 mg per tablet or capsule, e.g., Esgic, Fioricet, or Zebutal)
Adults
1 to 2 tablets or capsules PO every 4 hours as needed. Do not exceed 6 tablets or capsules in a 24-hour period.
Oral dosage (oral solution with 50 mg butalbital, 325 mg acetaminophen, and caffeine 40 mg per 15 mL, e.g., Alagesic LQ, Vanatol LQ)
Adults
15 mL to 30 mL PO every 4 hours as needed. Do not exceed 90 mL in a 24-hour period.
Children and Adolescents 12 years and older
15 mL to 30 mL PO every 4 hours as needed. Do not exceed 90 mL in a 24-hour period.
MAXIMUM DOSAGE
Adults
Acetaminophen 4 grams/day PO, caffeine 240 mg/day PO, or butalbital 300 mg/day PO.
Geriatric
Acetaminophen 4 grams/day PO, caffeine 240 mg/day PO, or butalbital 300 mg/day PO.
Adolescents
Acetaminophen 4 grams/day PO, caffeine 240 mg/day PO, or butalbital 300 mg/day PO.
Children
12 years: Acetaminophen 4 grams/day PO, caffeine 240 mg/day PO, or butalbital 300 mg/day PO.
Less than 12 years: Safety and efficacy have not been established.
Infants
Safety and efficacy have not been established.
DOSING CONSIDERATIONS
Hepatic Impairment
Acetaminophen should be used with extreme caution in patients with impaired hepatic function or with a history of overdose. Acetaminophen should not be used in patients with a history of alcoholism. Patients with stable hepatic disease may receive therapeutic doses of acetaminophen for episodic pain of short duration (< 5 days).
Renal Impairment
Dosage should be modified depending on clinical response and degree of renal impairment, but no quantitative recommendations are available.
What happens if I miss a dose?
Since this medicine is used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of Fioricet can be fatal.
The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.
Overdose symptoms may also include insomnia, restlessness, tremor, diarrhea, increased shallow breathing, uneven heartbeats, seizure (convulsions), or fainting.
