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Each Fioricet Tablets contains:

Butalbital ……………….. 50 mg

Warning: May be habit-forming.

Acetaminophen ………. 325 mg

Caffeine …………………. 40 mg

In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose with capsule shell composed of gelatin (silicon dioxide and sodium lauryl sulfate added as manufacturing aides to the gelatin) and titanium dioxide. Impriting ink composed of n-butyl alcohol, pharmaceutical glaze modified in SD-45, propylene glycol, SDA-3A alcohol, titanium dioxide, D&C Yellow No. 10 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake.

This combination medication is used to treat tension headaches. Acetaminophen helps to decrease the pain from the headache. Caffeine helps increase the effects of acetaminophen. Butalbital is a sedative that helps to decrease anxiety and cause sleepiness and relaxation.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by yourhealth care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This medication may also be used to treat migraine headaches.

Tension Headache

50 mg/300-325 mg/40 mg: 2 tablets or capsules PO q4hr; not to exceed 6 tablets or capsules/day

50 mg/500 mg/40 mg: 1 tablet/capsule PO q4hr; not to exceed 6 tablets or capsules/day

50 mg/750 mg/40 mg: 1 tablet/capsule PO q4hr; not to exceed 5 tablets or capsules/day

15-30 mL solution PO q4hr; not to exceed 180 mL solution/day

Not to exceed 4 g/day of acetaminophen for any dosage form or regimen

Butalbital (generic Fioricet) is a non-narcotic pain medication, often prescribed for tension headaches and migraines. Fioricet is a barbiturate (Butalbital), mixed with acetaminophen and caffeine.

Acetaminophen is a pain reliever and fever reducer. Caffeine is believed to constrict dilated blood vessels that may contribute to tension headaches. It is not considered a federal controlled medication.

You can not order Fioricet online everywhere in US because some states banned the online sale of this medication, but international pharmacies will still ship anywhere in USA.

Please inform yourself about the legality and risks of ordering from a International Pharmacies.

Fioricet Interaction

May be potentiated by MAOIs. May potentiate alcohol, general anesthetics, tranquilizers, sedative-hypnotics, other narcotic analgesics or CNS depressants. Induction of drug-metabolizing hepatic enzymes. Acetaminophen may cause false (+) urine test for 5-hydroxyindoleacetic acid. Codeine may increase serum amylase levels.

Check with your doctor:

If the medicine stops working as well as it did when you first started using it. This may mean that you are in danger of becoming dependent on the medicine. Do not try to get better pain relief by increasing the dose.
If you are having headaches more often than you did before you started taking this medicine. This is especially important if a new headache occurs within 1 day after you took your last dose of this medicine, headaches begin to occur every day, or a headache continues for several days in a row. This may mean that you are dependent on the medicine. Continuing to take this medicine will cause even more headaches later on. Your doctor can give you advice on how to relieve the headaches.

Check the labels of all nonprescription (over-the-counter [OTC]) or prescription medicines you now take. If any contain a barbiturate or acetaminophen, check with your health care professional. Taking them together with this medicine may cause an overdose.

The butalbital in this medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; other prescription pain medicine; narcotics; other barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Also, drinking large amounts of alcoholic beverages regularly while taking this medicine may increase the chance of liver damage, especially if you take more of this medicine than your doctor ordered or if you take it regularly for a long time. Therefore, do not drink alcoholic beverages, and check with your doctor before taking any of the medicines listed above, while you are using this medicine.

This medicine may cause some people to become drowsy, dizzy, or lightheaded. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert and clearheaded.

Before you have any medical tests, tell the person in charge that you are taking this medicine. Caffeine (present in some butalbital and acetaminophen combinations) interferes with the results of certain tests that use dipyridamole (e.g., Persantine) to help show how well blood is flowing to your heart. Caffeine should not be taken for 8 to 12 hours before the test. The results of other tests may also be affected by butalbital and acetaminophen combinations.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine. Serious side effects can occur if your medical doctor or dentist gives you certain medicines without knowing that you have taken butalbital.

If you have been taking large amounts of this medicine, or if you have been taking it regularly for several weeks or more, do not suddenly stop taking it without first checking with your doctor. Your doctor may want you to reduce gradually the amount you are taking before stopping completely in order to lessen the chance of withdrawal side effects.

If you think you or anyone else may have taken an overdose of this medicine, get emergency help at once. Taking an overdose of this medicine or taking alcohol or CNS depressants with this medicine may lead to unconsciousness or possibly death. Signs of butalbital overdose include severe drowsiness, confusion, severe weakness, shortness of breath or unusually slow or troubled breathing, slurred speech, staggering, and unusually slow heartbeat. Signs of severe acetaminophen poisoning may not occur until 2 to 4 days after the overdose is taken, but treatment to prevent liver damage or death must be started within 24 hours or less after the overdose is taken.

Tell your doctor of all prescription and nonprescription drugs you may use, especially of: “blood thinners” Tell your doctor or pharmacist of all prescription and nonprescription drugs you may use that cause drowsiness such as: medicine for sleep (e.g., sedatives), tranquilizers, anti-anxiety drugs (e.g., diazepam), narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., phenothiazines such as chlorpromazine, or tricyclics such as amitriptyline), anti-seizure drugs (e.g., carbamazepine), muscle relaxants, antihistamines that cause drowsiness (e.g., diphenhydramine). Because this medication contains acetaminophen, check with your doctor or pharmacist before taking other medications containing acetaminophen which is commonly found in nonprescription pain relievers and cough-and-cold products. Read labels carefully to check ingredients. This drug may interfere with the effectiveness of birth control pills. Discuss using other methods of birth control with your doctor. Do not start or stop any medicine without doctor or pharmacist approval.

Fioricet dosing information

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If butalbital and acetaminophen combination is taken regularly (for example, every day), it may become habit-forming (causing mental or physical dependence). The caffeine in some butalbital and acetaminophen combinations can also increase the chance of dependence. Dependence is especially likely to occur in patients who take these medicines to relieve frequent headaches. Taking too much of this medicine may also lead to liver damage or other medical problems.

This medicine will relieve a headache best if you take it as soon as the headache begins. If you get warning signs of a migraine, take this medicine as soon as you are sure that the migraine is coming. This may even stop the headache pain from occurring. Lying down in a quiet, dark room for a while after taking the medicine also helps to relieve headaches.

People who get a lot of headaches may need to take a different medicine to help prevent headaches. It is important that you follow your doctor’s directions about taking the other medicine, even if your headaches continue to occur. Headache-preventing medicines may take several weeks to start working. Even after they do start working, your headaches may not go away completely. However, your headaches should occur less often, and they should be less severe and easier to relieve than before. This will reduce the amount of headache relievers that you need. If you do not notice any improvement after several weeks of headache-preventing treatment, check with your doctor.

Dosing

The dose medicines in this class will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage forms (capsules or tablets):
- For tension headaches:
  - Adults—One or 2 capsules or tablets every four hours as needed. If your medicine contains 325 or 500 milligrams (mg) of acetaminophen in each capsule or tablet, you should not take more than six capsules or tablets a day. If your medicine contains 650 mg of acetaminophen in each capsule or tablet, you should not take more than four capsules or tablets a day.
  - Children—Dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Usual Adult Dose of Fioricet for Headache:

Acetaminophen 300 mg, butalbital 50 mg, and caffeine 40 mg:
1 or 2 capsule(s) orally every 4 hours as needed. Maximum daily dose: 6 doses.

Acetaminophen 325 mg, butalbital 50 mg, and caffeine 40 mg:
1 or 2 tablet(s), capsule(s), or tablespoonful(s) orally every 4 hours.
Maximum daily dose: 6 doses

Acetaminophen 500 mg, butalbital 50 mg, and caffeine 40 mg:
1 tablet or capsule orally every 4 hours.
Maximum daily dose: 6 doses

Acetaminophen 750 mg, butalbital 50 mg, and caffeine 40 mg:
1 tablet orally every 4 hours.
Maximum daily dose: 5 tablets

Usual Pediatric Dose of Fioricet for Headache:

12 years and older:
Acetaminophen 300 mg, butalbital 50 mg, and caffeine 40 mg:
1 or 2 capsule(s) orally every 4 hours as needed. Maximum daily dose: 6 doses.

How to Use Fioricet ?

To prevent upset stomach, take this medication with food or milk. Pain medications work best in preventing pain before it occurs.

Once the pain becomes intense, the medication is not as effective in relieving it. Take this as prescribed. Do not increase your dose or take it more frequently without your doctor’s approval.

Store at room temperature away from moisture and sunlight. Do not store in the bathroom or kitchen.

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.

Butalbital may be habit-forming. Never share Fioricet with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Selling or giving away Fioricet is against the law.

Take Fioricet 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.

Dosing

For oral dosage forms (capsules or tablets):
- For tension headaches:
  - Adults—One or 2 capsules or tablets every four hours as needed. If your medicine contains 325 or 500 milligrams (mg) of acetaminophen in each capsule or tablet, you should not take more than six capsules or tablets a day. If your medicine contains 650 mg of acetaminophen in each capsule or tablet, you should not take more than four capsules or tablets a day.
  - Children—Dose must be determined by your doctor.

Missed Dose

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Fioricet Adverse Reactions

Commonly reported side effects for Fioricet include:

- - Euphoria
  - Dizziness
  - Drowsiness
  - Intoxicated feeling
  - Light-headedness
  - Nausea
  - Vomiting
  - Sedation
  - Substance dependence
  - Shortness of breath
  - Abdominal pain

Fioricet is implicated as causing repeat headaches with over-use.

Side Effects

Drug information provided by: IBM Micromedex

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare

Bleeding or crusting sores on lips
chest pain
fever with or without chills
hive-like swellings (large) on eyelids, face, lips, and/or tongue
muscle cramps or pain
red, thickened, or scaly skin
shortness of breath, troubled breathing, tightness in chest, or wheezing
skin rash, itching, or hives
sores, ulcers, or white spots in mouth (painful)

Symptoms of overdose

Anxiety, confusion, excitement, irritability, nervousness, restlessness, or trouble in sleeping (severe, especially with products containing caffeine)
convulsions (seizures) (for products containing caffeine)
diarrhea, especially if occurring together with increased sweating, loss of appetite, and stomach cramps or pain
dizziness, lightheadedness, drowsiness, or weakness, (severe)
frequent urination (for products containing caffeine)
hallucinations (seeing, hearing, or feeling things that are not there)
increased sensitivity to touch or pain (for products containing caffeine)
muscle trembling or twitching (for products containing caffeine)
nausea or vomiting, sometimes with blood
ringing or other sounds in ears (for products containing caffeine)
seeing flashes of “zig-zag” lights (for products containing caffeine)
shortness of breath or unusually slow or troubled breathing
slow, fast, or irregular heartbeat
slurred speech
staggering
swelling, pain, or tenderness in the upper abdomen or stomach area
unusual movements of the eyes

Check with your doctor as soon as possible if any of the following side effects occur:

Less common

Confusion (mild)
mental depression
unusual excitement (mild)

Rare

Bloody or black, tarry stools
bloody urine
pinpoint red spots on skin
swollen or painful glands
unusual bleeding or bruising
unusual tiredness or weakness (mild

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Bloated or “gassy” feeling
dizziness or lightheadedness (mild)
drowsiness (mild)
nausea, vomiting, or stomach pain (occurring without other symptoms of overdose)

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Fioricet Precaution

Tell your doctor your medical history, especially of: serious liver disease, alcohol or narcotic dependence, emotional/mental conditions, heart disease (arrhythmias, recent MI), stomach/intestinal ulcers, any allergies.

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 prevent oversedation, avoid using alcohol and other sedative type medications while taking this. This drug may make you dizzy or drowsy; use caution engaging in activities requiring alertness such as driving or using machinery. Avoid alcoholic beverages.

This medication contains caffeine. Avoid drinking large amounts of caffeinated beverages while taking this medication as excessive nervousness and irritability can occur.

This medication should be used during pregnancy only if clearly needed. Small amounts of this medication appear in breast milk. Consult your doctor before breast-feeding.

Check with your doctor:

If the medicine stops working as well as it did when you first started using it. This may mean that you are in danger of becoming dependent on the medicine. Do not try to get better pain relief by increasing the dose.
If you are having headaches more often than you did before you started taking this medicine. This is especially important if a new headache occurs within 1 day after you took your last dose of this medicine, headaches begin to occur every day, or a headache continues for several days in a row. This may mean that you are dependent on the medicine. Continuing to take this medicine will cause even more headaches later on. Your doctor can give you advice on how to relieve the headaches.

Fioricet Mechanism of action

Fioricet is a brand name consisting of a combination of butalbital (a barbiturate), acetaminophen and caffeine which is indicated for the treatment of tension headaches, muscle contraction headaches and post-dural puncture headaches. Although not indicated, they are commonly used to treat migraines and other pain related ailments

Butalbital has generalized depressant effect on central nervous system and, in very high doses, has peripheral effects. Acetaminophen has analgesic and antipyretic effects mediated by a metabolite which acts atcannabinoid receptors, contrary to popular belief it is not an antiinflammatory at safe levels (it becomes toxic at doses above 1,000mg per dose and/or 3,000mg per day). Caffeine is thought to produce constriction ofcerebral blood vessels and serves to counteract the sedative effect of butalbital.

fioricetblue

Butalbital has a half-life of about 35 hours. Acetaminophen has a half-life of about 1.25 to 3 hours, but may be increased by liver damage and after an overdose. Caffeine has a half-life of about 5 to 7 hours.

Fioricet Mechanism of Action

Fioricet is a brand name consisting of a combination of butalbital (a barbiturate), APAP and caffeine which is indicated for the treatment of tension headaches, muscle contraction headaches and post-dural puncture headaches. 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.

Each tablet contains the following active ingredients:

- - butalbital USP . . . . . . . . . .50 mg
  - acetaminophen USP . . . . 325 mg
  - caffeine USP . . . . . . . . . . .40 mg

Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to intermediate-acting barbiturate.

Butalbital belongs to the group of medicines called barbiturates. Barbiturates act in the central nervous system (CNS) to produce their effects. When butalbital is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain.

Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely. It has the following structural formula:

Acetaminophen (4´-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic. Acetaminophen is used to relieve pain and reduce fever in patients.

It does not become habit-forming when taken for a long time. But acetaminophen may cause other unwanted effects when taken in large doses, including liver damage.

It has the following structural formula: Caffeine (1,3,7-trimethylxanthine), is a central nervous system stimulant.Caffeine is a CNS stimulant that is used with pain relievers to increase their effect. It has also been used for migraine headaches. However, caffeine can also cause physical dependence when it is used for a long time. This may lead to withdrawal (rebound) headaches when you stop taking it. It has the following structural formula: Inactive Ingredients: crospovidone, FD&C Blue #1 (aluminum lake), magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid.