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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® (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 analgesicand antipyretic. 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 Precution

PRECAUTIONS: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 regular use/abuse of drugs/alcohol, mental/mood disorders, abdominal/stomach problems (such as stomach ulcer).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

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.

This product contains acetaminophen, which may cause liver damage. Daily use of alcohol, especially when combined with acetaminophen, may increase your risk for liver damage. Avoid alcohol. Check with your doctor or pharmacist for more information.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

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 immediately if you notice any of these symptoms in your newborn.

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.

FIORICET DRUG INTERACTIONS:

Drug interactions may change how your Fioricet 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.

Before using Fioricet, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: 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 furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, rasagiline, 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), cyclosporine, doxycycline, estrogen, felodipine, metronidazole, quinidine, theophylline, certain beta blockers such as metoprolol, corticosteroids such as prednisone.

Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as certain antihistamines (such as diphenhydramine), anti-seizure drugs (such as carbamazepine), medicine for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (such as codeine), psychiatric medicines (such as risperidone, amitriptyline, trazodone).

Check the labels on all your medicines (such as cough-and-cold products) because they may contain caffeine or drowsiness-causing ingredients. Also keep in mind that certain beverages (such as coffee, colas, tea, energy drinks) contain caffeine. Ask your pharmacist about using those products safely.

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 whether your other prescription or nonprescription products contain acetaminophen. (See also adult maximum daily dose information in Side Effects section.)

Fioricet  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.

Fioricet  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.

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.

 

What Does Fioricet look like ?

 

What are the possible side effects of acetaminophen, butalbital, and caffeine?

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

Stop using this medication 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, stomach pain, low fever, 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 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.