Fioricet Side Effects

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.

Acetaminophen, butalbital, and caffeine is a combination medicine used to treat tension headaches that are caused by muscle contractions.

This combination medication Butalbital APAP Caffeine  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.

Acetaminophen, butalbital, and caffeine may also be used for purposes not listed in this medication guide.

Fioricet Side Effects

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:

Less common

  1. Confusion (mild)
  2. mental depression
  3. unusual excitement (mild)

Rare

  1. Bleeding or crusting sores on the lips
  2. chest pain
  3. fever with or without chills
  4. hive-like swellings on the eyelids, face, lips, or tongue
  5. hives, itching, or skin rash
  6. muscle cramps or pain
  7. red, thickened, or scaly skin
  8. seeing, hearing, or feeling things that are not there
  9. seizures
  10. sore throat
  11. sores, ulcers, or white spots in the mouth
  12. swollen or painful glands
  13. tightness in the chest
  14. troubled breathing

Incidence not known

  1. Agitation
  2. cough
  3. darkening of the skin
  4. diarrhea
  5. difficulty with swallowing
  6. dizziness
  7. fainting
  8. fever
  9. loss of appetite
  10. nausea
  11. overactive reflexes
  12. poor coordination
  13. puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  14. restlessness
  15. shivering
  16. talking or acting with excitement you cannot control
  17. trembling or shaking
  18. twitching
  19. unusual tiredness or weakness
  20. vomiting

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

  1. Anxiety (severe)
  2. cold and clammy skin
  3. confusion (severe)
  4. dizziness, lightheadedness, drowsiness, or weakness (severe)
  5. excitement (severe)
  6. increased sleepiness in babies (more than usual)
  7. increased sweating
  8. irritability (severe)
  9. limpness (in babies)
  10. nausea
  11. restlessness (severe)
  12. slow, fast, or irregular heartbeat
  13. slurred speech
  14. stomach cramps or pain
  15. swelling, pain, or tenderness in the upper abdomen or stomach area
  16. trembling or shaking of the hands or feet
  17. trouble sleeping (severe)
  18. unusually slow or troubled breathing
  19. vomiting

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:

Blue Fioricet – Lannett Co Inc Generic Fioricet Pill Identification: LCI | 1695

Butal/APAP/Caf 50-325-40mg Tab Lannett Co Inc Pill Identification: LCI | 1695
Butal/APAP/Caf 50-325-40mg Tab
Lannett Co Inc
Pill Identification: LCI | 1695

Lannett Company is a Generic Pharmaceutical Manufacturing and Development Company.

Founded in 1942, Lannett Company, Inc. is a leading manufacturer of over 100 unique pharmaceutical product families that save and enhance people’s lives. We are a US-based company, with our headquarters in Trevose, PA, and top-notch facilities for research and development, manufacturing, packaging, business, and distribution in three states including Pennsylvania, Indiana, and New York.

Their Top Products:

  • Lamivudine
  • Diazepam CIV
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  • Fluvastatin Tablets
  • Loratadine – Allergy
  • Ondansetron
  • Nystatin
  • Siltussin Sa
  • Atorvastatin Calcium
  • Lansoprazole

Their Fioricet ( Butalbital APAP Caffeine ) Prescription

FIoricet Butalbital APAP Caffeine - Lannett
FIoricet Butalbital APAP Caffeine – Lannett

Their Prescription Introduction:

BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE- butalbital, acetaminophen, and caffeine tablet 
Lannett Company, Inc.

———-

Butalbital, Acetaminophen, and Caffeine Tablets, USP
50 mg/325 mg/40 mg

Butalbital, Acetaminophen, and Caffeine Tablets, USP
50 mg/325 mg/40 mg

Rx only

Hepatotoxicity

Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen containing product.

DESCRIPTION

Butalbital, Acetaminophen, and Caffeine Tablets, USP are 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: microcrystalline cellulose, crospovidone, croscarmellose sodium, corn starch, stearic acid, colloidal silicon dioxide, magnesium stearate, and FD&C Blue No. 1.

Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to intermediate-acting barbiturate. It has the following structural formula:
Acetaminophen (4´-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:

Caffeine (1,3,7-trimethylxanthine), is a central nervous system stimulant. It has the following structural formula:

CLINICAL PHARMACOLOGY

This combination drug product is intended as a treatment for tension headache.

It consists of a fixed combination of butalbital, acetaminophen, and caffeine. The role each component plays in the relief of the complex of symptoms known as tension headache is incompletely understood.

Pharmacokinetics

The behavior of the individual components is described below.

Butalbital

Butalbital is well absorbed from the gastrointestinal tract and is expected to distribute to most tissues in the body. Barbiturates in general may appear in breast milk and readily cross the placental barrier. They are bound to plasma and tissue proteins to a varying degree and binding increases directly as a function of lipid solubility.

Elimination of butalbital is primarily via the kidney (59% to 88% of the dose) as unchanged drug or metabolites. The plasma half-life is about 35 hours. Urinary excretion products include parent drug (about 3.6% of the dose), 5-isobutyl-5-(2, 3-dihydroxypropyl) barbituric acid (about 24% of the dose), 5-allyl-5(3-hydroxy-2-methyl-1-propyl) barbituric acid (about 4.8% of the dose), products with the barbituric acid ring hydrolyzed with excretion of urea (about 14% of the dose), as well as unidentified materials. Of the material excreted in the urine, 32% is conjugated.

The in vitro plasma protein binding of butalbital is 45% over the concentration range of 0.5-20 mcg/mL. This falls within the range of plasma protein binding (20%-45%) reported with other barbiturates such as phenobarbital, pentobarbital, and secobarbital sodium. The plasma-to-blood concentration ratio was almost unity, indicating that there is no preferential distribution of butalbital into either plasma or blood cells.

See OVERDOSAGE for toxicity information.

Acetaminophen

Acetaminophen is rapidly absorbed from the gastrointestinal tract and is distributed throughout most body tissues. The plasma half-life is 1.25 to 3 hours, but may be increased by liver damage and following overdosage. Elimination of acetaminophen is principally by liver metabolism (conjugation) and subsequent renal excretion of metabolites. Approximately 85% of an oral dose appears in the urine within 24 hours of administration, most as the glucuronide conjugate, with small amounts of other conjugates and unchanged drug.

See OVERDOSAGE for toxicity information.

Caffeine

Like most xanthines, caffeine is rapidly absorbed and distributed in all body tissues and fluids, including the CNS, fetal tissues, and breast milk.

Caffeine is cleared through metabolism and excretion in the urine. The plasma half-life is about 3 hours. Hepatic biotransformation prior to excretion results in about equal amounts of 1-methylxanthine and 1-methyluric acid. Of the 70% of the dose that is recovered in the urine, only 3% is unchanged drug.

See OVERDOSAGE for toxicity information.

INDICATIONS AND USAGE

Butalbital, acetaminophen, and caffeine tablets, USP are indicated for the relief of the symptom complex of tension (or muscle contraction) headache.

Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.

CONTRAINDICATIONS

This product is contraindicated under the following conditions:

– Hypersensitivity or intolerance to any component of this product
– Patients with porphyria.

WARNINGS

Hepatotoxicity

Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen containing product. The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products.

The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen.

Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one product that contains acetaminophen. Instruct patients to seek medical attention immediately upon ingestion of more than 4000 milligrams of acetaminophen per day, even if they feel well.

Serious Skin Reactions

Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Patients should be informed about the signs of serious reactions, and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.

Hypersensitivity/anaphylaxis

There have been post-marketing reports of hypersensitivity and anaphylaxis associated with use of acetaminophen. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, pruritus, and vomiting. There were infrequent reports of life-threatening anaphylaxis requiring emergency medical attention. Instruct patients to discontinue butalbital, acetaminophen, and caffeine tablets, USP immediately and seek medical care if they experience these symptoms. Do not prescribe butalbital, aceta­minophen, and caffeine tablets, USP for patients with acetaminophen allergy.

Butalbital is habit-forming and potentially abusable. Consequently, the extended use of this product is not recommended.

PRECAUTIONS

General

Butalbital, acetaminophen, and caffeine tablets, USP should be prescribed with caution in certain special-risk patients, such as the elderly or debilitated, and those with severe impairment of renal or hepatic function, or acute abdominal conditions.

Information for Patients/Caregivers

This product may impair mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Such tasks should be avoided while taking this product.

Alcohol and other CNS depressants may produce an additive CNS depression when taken with this combination product, and should be avoided.

Butalbital may be habit-forming. Patients should take the drug only for as long as it is prescribed, in the amounts prescribed, and no more frequently than prescribed.

For information on use in geriatric patients, see PRECAUTIONS/Geriatric Use.

  • Do not take butalbital, acetaminophen, and caffeine tablets, USP if you are allergic to any of its ingredients.
  • If you develop signs of allergy such as a rash or difficulty breathing stop taking butal­bital, acetaminophen, and caffeine tablets, USP and contact your healthcare provider immediately.
  • Do not take more than 4000 milligrams of acetaminophen per day. Call your doctor if you took more than the recommended dose.

Laboratory Tests

In patients with severe hepatic or renal disease, effects of therapy should be monitored with serial liver and/or renal function tests.

Drug Interactions

The CNS effects of butalbital may be enhanced by monoamine oxidase (MAO) inhibitors.

Butalbital, acetaminophen, and caffeine may enhance the effects of: other narcotic analgesics, alcohol, general anesthetics, tranquilizers such as chlordiazepoxide, sedative-hypnotics, or other CNS depressants, causing increased CNS depression.

Drug/Laboratory Test Interactions

Acetaminophen may produce false-positive test results for urinary 5-hydroxyindoleacetic acid.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No adequate studies have been conducted in animals to determine whether acetaminophen or butalbital have a potential for carcinogenesis, mutagenesis or impairment of fertility.

Pregnancy

Teratogenic Effects

Pregnancy Category C:

Animal reproduction studies have not been conducted with this combination product. It is also not known whether butalbital, acetaminophen, and caffeine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This product should be given to a pregnant woman only when clearly needed.

Nonteratogenic Effects

Withdrawal seizures were reported in a two-day-old male infant whose mother had taken a butalbital-containing drug during the last two months of pregnancy. Butalbital was found in the infant’s serum. The infant was given phenobarbital 5 mg/kg, which was tapered without further seizure or other withdrawal symptoms.

Nursing Mothers

Caffeine, barbiturates, and acetaminophen are excreted in breast milk in small amounts, but the significance of their effects on nursing infants is not known. Because of potential for serious adverse reactions in nursing infants from butalbital, acetaminophen, and caffeine, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 12 have not been established.

Geriatric Use

Clinical studies of butalbital, acetaminophen, and caffeine tablets, USP did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Butalbital is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

ADVERSE REACTIONS

Frequently Observed

The most frequently reported adverse reactions are drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, abdominal pain, and intoxicated feeling.

Infrequently Observed

All adverse events tabulated below are classified as infrequent.

Central Nervous System: headache, shaky feeling, tingling, agitation, fainting, fatigue, heavy eyelids, high energy, hot spells, numbness, sluggishness, seizure. Mental confusion, excitement, or depression can also occur due to intolerance, particularly in elderly or debilitated patients, or due to overdosage of butalbital.

Autonomic Nervous System: dry mouth, hyperhidrosis.

Gastrointestinal: difficulty swallowing, heartburn, flatulence, constipation.

Cardiovascular: tachycardia.

Musculoskeletal: leg pain, muscle fatigue.

Genitourinary: diuresis.

Miscellaneous: pruritus, fever, earache, nasal congestion, tinnitus, euphoria, allergic reactions.

Several cases of dermatological reactions, including toxic epidermal necrolysis and erythema multiforme, have been reported.

The following adverse drug events may be borne in mind as potential effects of the components of this product. Potential effects of high dosage are listed in the OVERDOSAGE section.

Acetaminophen: allergic reactions, rash, thrombocytopenia, agranulocytosis.

Caffeine: cardiac stimulation, irritability, tremor, dependence, nephrotoxicity, hyperglycemia.

DRUG ABUSE AND DEPENDENCE

Abuse and Dependence

Butalbital

Barbiturates may be habit-forming: Tolerance, psychological dependence, and physical dependence may occur especially following prolonged use of high doses of barbiturates. The average daily dose for the barbiturate addict is usually about 1500 mg. As tolerance to barbiturates develops, the amount needed to maintain the same level of intoxication increases; tolerance to a fatal dosage, however, does not increase more than two-fold. As this occurs, the margin between an intoxication dosage and fatal dosage becomes smaller. The lethal dose of a barbiturate is far less if alcohol is also ingested. Major withdrawal symptoms (convulsions and delirium) may occur within 16 hours and last up to 5 days after abrupt cessation of these drugs. Intensity of withdrawal symptoms gradually declines over a period of approximately 15 days. Treatment of barbiturate dependence consists of cautious and gradual withdrawal of the drug. Barbiturate-dependent patients can be withdrawn by using a number of different withdrawal regimens. One method involves initiating treatment at the patient’s regular dosage level and gradually decreasing the daily dosage as tolerated by the patient.

OVERDOSAGE

Following an acute overdosage of butalbital, acetaminophen, and caffeine, toxicity may result from the barbiturate or the acetaminophen. Toxicity due to caffeine is less likely, due to the relatively small amounts in this formulation.

Signs and Symptoms

Toxicity from barbiturate poisoning include drowsiness, confusion, and coma; respiratory depression; hypotension; and hypovolemic shock.

In acetaminophen overdosage: dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necrosis, hypoglycemic coma, and coagulation defects may also occur. Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis, and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion. In adults hepatic toxicity has rarely been reported with acute overdoses of less than 10 grams, or fatalities with less than 15 grams.

Acute caffeine poisoning may cause insomnia, restlessness, tremor, and delirium, tachycardia and extrasystoles.

Treatment

A single or multiple overdose with this combination product is a potentially lethal polydrug overdose, and consultation with a regional poison control center is recommended.

Immediate treatment includes support of cardiorespiratory function and measures to reduce drug absorption. Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated. Assisted or controlled ventilation should also be considered.

Gastric decontamination with activated charcoal should be administered just prior to N-acetylcysteine (NAC) to decrease systemic absorption if acetaminophen ingestion is known or suspected to have occurred within a few hours of presentation. Serum acetaminophen levels should be obtained immediately if the patient presents 4 hours or more after ingestion to assess potential risk of hepatotoxicity; acetaminophen levels drawn less than 4 hours post-ingestion may be misleading. To obtain the best possible outcome, NAC should be administered as soon as possible where impending or evolving liver injury is suspected. Intravenous NAC may be administered when circumstances preclude oral administration.

Vigorous supportive therapy is required in severe intoxication. Procedures to limit the continuing absorption of the drug must be readily performed since the hepatic injury is dose dependent and occurs early in the course of intoxication.

DOSAGE AND ADMINISTRATION

One or 2 tablets every 4 hours as needed. Total daily dosage should not exceed 6 tablets.

Extended and repeated use of this product is not recommended because of the potential for physical dependence.

HOW SUPPLIED

Butalbital, Acetaminophen, and Caffeine Tablets, USP contain 50 mg butalbital, 325 mg acetaminophen, and 40 mg caffeine.

Butalbital, Acetaminophen, and Caffeine Tablets USP, 50 mg/325mg/40 mg are light-blue, speckled, round uncoated tablets, debossed “1695” on one side and “LCI” on the other side and are supplied in bottles of 100 (NDC 0527-1695-01) and bottles of 500 (NDC 0527-1695-05).

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).

Distributed by:
Lannett Company, Inc.
Philadelphia, PA 19136

CIB70307C

Rev. 07/20

PRINCIPAL DISPLAY PANEL – 50 mg/325 mg/40 mg Tablet Bottle Label

NDC 0527-1695-01

Butalbital,
Acetaminophen,
and Caffeine
Tablets, USP

50 mg/325 mg/40 mg

Rx Only

100 Tablets

Lannett

BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE
butalbital, acetaminophen, and caffeine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0527-1695
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUTALBITAL (UNII: KHS0AZ4JVK) (BUTALBITAL – UNII:KHS0AZ4JVK) BUTALBITAL 50 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN – UNII:362O9ITL9D) ACETAMINOPHEN 325 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE – UNII:3G6A5W338E) CAFFEINE 40 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSPOVIDONE (UNII: 2S7830E561)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
Product Characteristics
Color BLUE (Light-blue, speckled) Score no score
Shape ROUND Size 11mm
Flavor Imprint Code LCI;1695
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0527-1695-01 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/13/2012
2 NDC:0527-1695-05 500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/13/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200243 09/13/2012
Labeler – Lannett Company, Inc.
(002277481)
Establishment
Name Address ID/FEI Business Operations
Lannett Company, Inc. 829757603 ANALYSIS(0527-1695)
Establishment
Name Address ID/FEI Business Operations
Lannett Company, Inc. 006422406 LABEL(0527-1695) , MANUFACTURE(0527-1695) , PACK(0527-1695)

Revised: 7/2020

Lannett Company, Inc.

Fioricet Clinical Pharmacology

Fioricet is intended as a treatment for tension headache.

It consists of a fixed combination of butalbital, acetaminophen, and caffeine. The role each component plays in the relief of the complex of symptoms known as tension headache is incompletely understood.

Pharmacokinetics

The behavior of the individual components is described below.

Butalbital

Butalbital is well absorbed from the gastrointestinal tract and is expected to distribute to most tissues in the body. Barbiturates in general may appear in breast milk and readily cross the placental barrier. They are bound to plasma and tissue proteins to a varying degree and binding increases directly as a function of lipid solubility.

Elimination of butalbital is primarily via the kidney (59% to 88% of the dose) as unchanged drug or metabolites. The plasma half-life is about 35 hours. Urinary excretion products include parent drug (about 3.6% of the dose), 5-isobutyl-5-(2, 3-dihydroxypropyl) barbituric acid (about 24% of the dose), 5-allyl-5(3-hydroxy-2-methyl-1-propyl) barbituric acid (about 4.8% of the dose), products with the barbituric acid ring hydrolyzed with excretion of urea (about 14% of the dose), as well as unidentified materials. Of the material excreted in the urine, 32% is conjugated.

The in vitro plasma protein binding of butalbital is 45% over the concentration range of 0.5-20 mcg/mL. This falls within the range of plasma protein binding (20%-45%) reported with other barbiturates such as phenobarbital, pentobarbital, and secobarbital sodium. The plasma-to-blood concentration ratio was almost unity, indicating that there is no preferential distribution of butalbital into either plasma or blood cells.

Acetaminophen

Acetaminophen is rapidly absorbed from the gastrointestinal tract and is distributed throughout most body tissues. The plasma half-life is 1.25 to 3 hours, but may be increased by liver damage and following overdosage. Elimination of acetaminophen is principally by liver metabolism (conjugation) and subsequent renal excretion of metabolites. Approximately 85% of an oral dose appears in the urine within 24 hours of administration, most as the glucuronide conjugate, with small amounts of other conjugates and unchanged drug.

Caffeine

Like most xanthines, caffeine is rapidly absorbed and distributed in all body tissues and fluids, including the CNS, fetal tissues, and breast milk.

Caffeine is cleared through metabolism and excretion in the urine. The plasma half-life is about 3 hours. Hepatic biotransformation prior to excretion results in about equal amounts of 1-methylxanthine and 1-methyluric acid. Of the 70% of the dose that is recovered in the urine, only 3% is unchanged drug.

Mechanism of Action

Butalbital: Barbiturate; elicits generalized CNS depressant effects; depresses sensory cortex; decreases motor activity

Acetaminophen: Nonopioid, nonsalicylate analgesic; acts on hypothalamus to produce analgesia and antipyresis

Caffeine: Vasoconstrictive properties of cerebral blood vessels may be helpful when treating headaches; improves skeletal muscle contraction and medullary respiratory center sensitivity; stimulates central inspiratory drive

Absorption

Butalbital and caffeine: Well absorbed

Bioavailability: 100% acetaminophen

Distribution

Protein bound: Butalbital (45%); acetaminophen (20-50%)

Metabolism

Butalbital

  • Metabolized in liver by CYP450 enzyme system
  • Induces hepatic enzymes, but to lesser degree than phenobarbital

Acetaminophen

  • Metabolized in liver by microsomal enzyme systems
  • 80-85% conjugated principally with glucuronic acid and to a lesser extent with sulfuric acid and cysteine
  • 4% metabolized by CYP450 to toxic metabolite (N acetyl-p-benzoquinoneimine, N-acetylimidoquinone [NAPQI]), which is detoxified by conjugation with glutathione; high doses may deplete fixed amount of glutathione in body, causing NAPQI accumulation

Caffeine

  • Metabolized in liver via CYP1A2 to paraxanthine, theobromine, and theophylline

Elimination

Half-life: 35 hr butalbital; 2-4 hr acetaminophen; 3-7 hr caffeine

Excretion: Butalbital (59-88% in urine); acetaminophen (90-100% in urine, principally as acetaminophen glucuronide with acetaminophen sulfate/mercaptate); caffeine (principally in urine)

 

Fioricet Overdose Signs and Symptoms, and Treatment

Following an acute overdosage of butalbital, acetaminophen, and caffeine, toxicity may result from the barbiturate or the acetaminophen. Toxicity due to caffeine is less likely, due to the relatively small amounts in this formulation.

Fioricet is a combination prescription medication used to treat migraines and tension headaches. Keep the following key points in mind regarding Fioricet:

    • Fioricet includes butalbital, acetaminophen and caffeine
    • Fioricet is a controlled substance and should be taken exactly as prescribed
    • As a depressant, Fioricet can have side effects like feeling sluggish or drowsiness as the body adjusts to the medication. In rare cases, side effects can be more severe.
    • Fioricet can interact with other drugs and health conditions and you should speak to a doctor if you are taking other medications, have any other health conditions or are pregnant
    • Fioricet has some addictive qualities
    • Misusing Fioricet can be dangerous or deadly

 

Signs and Symptoms

Toxicity from barbiturate poisoning include drowsiness, confusion, and coma; respiratory depression; hypotension; and hypovolemic shock.

In acetaminophen overdosage: dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necroses, hypoglycemic coma, and thrombocytopenia may also occur. Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis, and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion. In adults hepatic toxicity has rarely been reported with acute overdoses of less than 10 grams, or fatalities with less than 15 grams.

Acute caffeine poisoning may cause insomnia, restlessness, tremor, and delirium, tachycardia and extrasystoles.

Treatment

A single or multiple overdose with Fioricet is a potentially lethal polydrug overdose, and consultation with a regional poison control center is recommended.

Immediate treatment includes support of cardiorespiratory function and measures to reduce drug absorption. Vomiting should be induced mechanically, or with syrup of ipecac, if the patient is alert (adequate pharyngeal and laryngeal reflexes). Oral activated charcoal (1 g/kg) should follow gastric emptying. The first dose should be accompanied by an appropriate cathartic. If repeated doses are used, the cathartic might be included with alternate doses as required. Hypotension is usually hypovolemic and should respond to fluids. Pressors should be avoided. A cuffed endotracheal tube should be inserted before gastric lavage of the unconscious patient and when necessary, to provide assisted respiration. If renal function is normal, forced diuresis may aid in the elimination of the barbiturate. Alkalinization of the urine increases renal excretion of some barbiturates, especially phenobarbital.

Meticulous attention should be given to maintaining adequate pulmonary ventilation. In severe cases of intoxication, peritoneal dialysis, or preferably hemodialysis may be considered. If hypoprothrombinemia occurs due to acetaminophen overdose, vitamin K should be administered intravenously.

If the dose of acetaminophen may have exceeded 140 mg/kg, acetylcysteine should be administered as early as possible. Serum acetaminophen levels should be obtained, since levels four or more hours following ingestion help predict acetaminophen toxicity. Do not await acetaminophen assay results before initiating treatment. Hepatic enzymes should be obtained initially, and repeated at 24-hour intervals.

Methemoglobinemia over 30% should be treated with methylene blue by slow intravenous administration.

Toxic Doses (for adults)

 Butalbital:

    toxic dose

   1 g

   (20 tablets)

 Acetaminophen:

    toxic dose

   10 g

   (30 tablets)

 Caffeine:

    toxic dose

   1 g

   (25 tablets)

In all cases of suspected overdosage, call your Regional Poison Control Center to obtain the most up-to-date information about the treatment of overdosage. Telephone numbers of certified Regional Poison Control Centers are listed in the Physicians’ Desk Reference®.

Acetaminophen Overdose

Do not take Fioricet along with other medications that contain acetaminophen as it can be toxic to the liver.

In the event of an overdose on Fioricet, call 911 immediately. Emergency treatment is critical to ensure the person remains stable. After the immediate overdose risk is averted, subsequent care is essential to effectively address the drug abuse or addiction issue.

Fioricet rehab treatment normally begins with the detoxification phase. This process reduces the patient’s dosage of Fioricet until they are no longer taking the drug at all. The detoxification phase of the treatment eliminates the patient’s physical dependence on Fioricet. The remainder of a treatment program for Fioricet addiction deals primarily with the psychological aspect of the addiction.

Barbiturate Withdrawal Following Internet Purchase of Fioricet

Who can not buy fioricet in our website online ?

All the pharmacies in our warehouses are US licensed pharmacies and you can get the pharmacy name, the pharmacists name and the doctor name in the bottle we sent you.

You can also get the full prescription profile when you buy the prescription in our online pharmacies. But we do not ship to all patients:

    • The first time buyer. We do not sell to patient who has not seen a local doctors that prescribed him a Fioricet prescription;
    • The patient has a history of mental illness or suicidal thoughts;
    • The patient has liver disease;
    • The patient has heart disease;
    • The patient has kidney disease;
    • The patient has drug or alcohol addiction history;
    • The patient has taken a MAO inhibitor in the past 14 days;
    • The patient is allergic to acetaminophen, butalbital, or caffeine;
    • The patient has cirrhosis disease;
    • The patient has asthma, sleep apnea, or other breathing disorder;
    • The patient has stomach ulcer or bleeding;
    • The patient has a history of skin rash caused by any medication;
    • The patient uses medicine to prevent blood clots
    • The patient is pregnant; life-threatening withdrawal symptoms in the baby after it is born
    • The patient is breastfeeding because this medicine can pass into breast milk and may harm a nursing baby.

You  cannot order in our website if you

    • have not picked up after clicking placing order button;
    • send us a bounced check;
    • send us a check not money order;
    • keep emailing us for a single order ID
    • asked a charge back before

Background  The Internet enables businesses to advertise their pharmaceutical products and services without medical supervision. The Internet also allows for the unsupervised purchase of medications that may have neurologic consequences.

Objective  To describe acute withdrawal delirium following the abrupt discontinuation of Fioricet.

Patient  The patient was a 37-year-old woman with a history of depression and migraine headaches but not drug abuse. She developed a florid withdrawal delirium following the discontinuation of a drug she purchased online. The medication, which contained butalbital, was self-administered in escalating doses for the treatment of chronic headaches. Daily doses of up to 750 mg to 1000 mg were reported.

Results  The patient was admitted to the hospital for the treatment of unexplained seizures that were followed by several days of an intense withdrawal syndrome. Little improvement was noted after the administration of benzodiazepines and phenothiazine. After parenteral phenobarbital administration, her symptoms resolved.

Conclusions  The withdrawal state from barbiturates is similar to that from ethanol. Tolerance can develop with prolonged abuse, leading to escalating drug doses to achieve the desired effect.

The suggested management of both types of withdrawal syndromes is similar, but the relative resistance of the behavioral and autonomic features in patients was remarkable.

Physicians should be aware of the ease with which medications can be purchased without supervision from Internet pharmacies. The magnitude of the number of drugs that are made available through this means creates a proclivity to withdrawal states.

Pregnancy

Case reports of withdrawal seizures in newborns whose mothers had taken butalbital-containing drug during pregnancy

Lactation

Excreted in breast milk in small amounts; not recommended

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

 

Order Prescription Fioricet (Butalbital APAP Caffeine) Online

Fioricet is a pain reliever and sedative medication to relieve mild to moderate pain and tension headaches.

Pain can interrupt all parts of life, from work to home life. Of course, if you were in pain the last thing you want to do is go stand in line at the drugstore. While ordering Affordable Fioricet (Butalbital APAP Caffeine) online won’t allow you to leave your house, your medication will be sent directly to your door and ensuring that you are finally able to access the help that you need.

The combination of acetaminophen, Butalbital, Caffeine comes as a capsule and tablet to take by mouth. It usually is taken every 4 hours as needed. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take acetaminophen, Butalbital, Caffeine exactly as directed. Do not take more than six tablets or capsules in 1 day. If you think that you need more to relieve your symptoms, call your doctor.

This medication can be habit-forming. Do not take a larger dose, take it more often, or for a longer period than your doctor tells you to.

Like just about everything else out there, the price of pain medication has been rising steadily more than the years. even though you are currently on the pain prescription, then you definitely know it can cost rather a bit to keep up with your monthly prescriptions even with wellness insurance policies footing most of the bill.

Even though you will not have health insurance policy, then this expense becomes even a lot more of the burden. That is why numerous consumers now choose to order prescription Fioricet(Butalbital APAP Caffeine) online.

Fioricet is used to treat tension headaches that are caused by muscle contractions. It comes as a capsule and pill form to take by mouth. One or 2 pills every 4 hours as needed. Total daily dosage should not exceed 6 pills. Extended and repeated use of this product is not recommended because of the potential for physical dependence.

When you order prescription Fioricet (Butalbital APAP Caffeine) Online our process could not be simpler, just select the Generic Soma ( Carisoprodol) medicines you need, fill in our medical questionnaire, and submit your order. Our U.S Licensed Physicians will review your order and issue your prescription. Next, our U.S. Licensed Pharmacies will dispense, and FedEx your order discreetly using Next day delivery.

At USAhealthStore, you can contact us at any time either by clicking the Live Help button for a live chat session with our customer service staff, or you can call us toll-free on 877-479-2455. We look forward to helping you with all your medical needs, this time, and in the future.

Information About Fioricet :

Fioricet – Important note : The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of Fioricet is safe, appropriate, or effective for you. Consult your healthcare professional before using Fioricet.

BUTALBITAL/ACETAMINOPHEN/CAFFEINE – ORAL (byou-TAL-bih-tall/uh-seet-uh-MEE-no-fen/kaff-EEN)

Fioricet common brand names : Esgic, Fioricet

Fioricet uses :

Fioricet is a pain reliever and sedative. It is used to relieve mild to moderate pain and tension headaches.

How to use Fioricet :

To prevent upset stomach, take Fioricet 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 Fioricet as prescribed. Do not increase your dose of Fioricet or take it more frequently without your doctor’s approval.

Fioricet side effects :

Fioricet may cause the following side effects the first few days as your body adjusts to the medication:

  • lightheadedness;
  • dizziness;
  • drowsiness;
  • stomach upset;
  • nausea;
  • sleeping disturbances.

If these symptoms persist or become bothersome, inform your doctor. Notify your doctor immediately if you develop a rapid/ irregular heartbeat.

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 of Fioricet not listed above, contact your doctor or pharmacist.

Fioricet precautions :

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 Fioricet. Fioricet may make you dizzy or drowsy; use caution engaging in activities requiring alertness such as driving or using machinery. Avoid alcoholic beverages.

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

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

Fioricet – Drug interactions :

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 Fioricet 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.

Fioricet 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 overdose :

If Fioricet overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of Fioricet overdose may include :

  • vomiting;
  • unusual drowsiness;
  • lack of feeling alert;
  • slow or shallow breathing;
  • cold or clammy skin;
  • loss of consciousness;
  • dark urine;
  • stomach pain;
  • extreme fatigue.

Fioricet – Missed dose :

If you miss Fioricet dose, take it as soon as remembered; do not take if it is almost time for the next dose, instead, skip the missed dose and resume your usual dosing schedule. Do not “double-up” the Fioricet dose to catch up.

Fioricet storage :

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

What You Have to Know Before You Take Fioricet ?

What is Fioricet and How to Use it ?

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.

How to Use Fioricet ?

Take this medication by mouth with or without food as directed by your doctor, usually every 4 hours as needed.

If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.

The dosage is based on your medical condition, age, and response to treatment. This medication works best if it is used as the first signs of a headache occur. If you wait until the headache has worsened, the medication may not work as well.

If you suddenly stop using this medication, you may have withdrawal symptoms (such as nausea/vomiting, mental/mood changes, seizures). To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used this medication for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal.

Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Take this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.

Tell your doctor if you notice increased use of this medication, a worsening of headaches, an increase in the number of headaches, the medication not working as well, or use of this medication for more than 2 headache episodes a week. Do not take more than recommended. Your doctor may need to change your medication and/or add a separate medication to prevent the headaches.

What You have to Know Before You Take Fioricet ?

If you have liver disease, kidney disease, heart disease, or you are drinking alcohol, please donot take fioricet. If you are taking other pain killer than contains acetaminophen, please donot take fioricet;

If you have porphyria, or if you have recently used alcohol, sedatives, tranquilizers, or other narcotic medications. Please donot take fioricet.

Do not take Fioricet if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

If you are pregnant, or you are breast feeding, please do not order fioricet online. Go to your street doctors and they may find the best solutions for your headache. If they prescribe you fioricet, you can order online.

Take Fioricet Generic exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

The max dosage is six tablets per day. Never exceed six tablets per day because fioricet contain tylenol (Acetaminophen ), overdose acetaminophen is the most dangerous thing in the world even worse than you addictive to alcohol. Because acetaminophen overdose will seriously damage your kidney and liver. This kind of damage cannot be recovered.

You can take fioricet with water or liquid milk. You can take fioricet with food if you have stomach problems. Never take fioricet with coffee or tea, never take fioricet with some flower drink.

Fioricet is the best pain reliever for tension headache if you take it as soon as the pain 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 head pain from occurring. Lying down in a quiet, dark room for a while after taking the medicine also helps to relieve head pain.

Health Questionnaires about Ordering Gabapentin, Fioricet Online

What your doctors and your pharmacists want to know about your health questionnaires when you buy Gabapentin, buy fioricet online.

The Doctors and pharmacists need know yours:

1. Male, or Female;

2. Height;

3. Weight;

4. Do you currently have a primary Care physican?

5. Your Date of Birth;

6. Please list anything in your medical history that you think might be relevant;

7. Your family medical history;

8. Have you did physical exam in past 12 months;

9. Is your personal health care practitioner knows that you are requestioning this medicine ?

10. Have you taken this medicine before;

11. Do you have some seasonal allergies;

12. All medical condition requesting you to take this medicine

13. What medicines you are having allergy to;

14. Do you have any medical problems;

15. Are you currently treatment any health problems;

16. Do you have high blood pressure ?

17. List all prescriptions you are currently taking;

18. List all OTC medicines you are currently taking;

19. For women, If you are pregnant or you want to be pregnant.

Please be honest to complete the website health questionnaire form. The doctors and pharmacists will review your orders according to the information you provide here. And you must agree that you will never overdose your prescription.

If you have over-dosage, or drunk addictive, drug addictive history, please do not order prescription online.

 

What You Should Know Before You Take Fioricet ?

It is very important that your doctor check your progress while you are using this medicine, especially within the first 24 to 72 hours of treatment.

This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

Fioricet with 123 in the back
Fioricet with 123 in the back

Do not use this medicine if you are using or have used an MAO inhibitor (MAOI) such as isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]) within the past 14 days.

If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Signs of an overdose include: dark urine, difficult or troubled breathing, irregular, fast or slow, or shallow breathing, nausea or vomiting, pain in the upper stomach, pale or blue lips, fingernails, or skin, pinpoint pupils of the eyes, or yellow eyes or skin.

This medicine may cause sleep-related breathing problems (eg, sleep apnea, sleep-related hypoxemia). Your doctor may decrease your dose if you have sleep apnea (stop breathing for short periods during sleep) while using this medicine.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Also, there may be a greater risk of liver damage if you drink 3 or more alcoholic beverages while you are taking acetaminophen. Do not drink alcoholic beverages, and check with your doctor before taking any of these medicines while you are using this medicine.

Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help. Also, lying down for a while may relieve dizziness or lightheadedness. If this problem continues or gets worse, check with your doctor right away.

This medicine may make you dizzy, drowsy, confused, or disoriented. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause serious allergic reactions, including anaphylaxis or certain skin conditions (eg, Stevens-Johnson syndrome). These reactions can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, blistering, peeling, or loosening of the skin, fever or chills, trouble breathing or swallowing, or any swelling of your hands, face, mouth, or throat while you are using this medicine.

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

Using this medicine while you are pregnant may cause serious unwanted effects, including neonatal withdrawal syndrome in your newborn baby. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine.

Codeine is changed to morphine in the body. Some people change codeine to morphine more quickly than others. These individuals are called “ultra-rapid metabolizers of codeine”.Contact your doctor immediately if you experience extreme sleepiness, confusion, or shallow breathing. These symptoms may indicate that you are an “ultra-rapid metabolizer of codeine”. As a result, there is too much morphine in the body and more side effects of morphine than usual. Children may be especially sensitive to this effect. Do not give this medicine to:

  • Children younger than 12 years of age.
  • Children younger than 18 years of age who have had surgery removal of tonsils or adenoids.
  • Children 12 to 18 years of age who have a high risk for breathing problems (eg, obstructive sleep apnea, obesity, lung disease).

If a nursing mother is an ultra-rapid metabolizer of codeine, it could lead to a morphine overdose in the nursing baby and cause very serious side effects.

For nursing mothers taking this medicine:

  • Talk to your doctor if you have any questions about taking codeine or about how this medicine may affect your baby.
  • Call your doctor if you become extremely tired and have difficulty caring for your baby.
  • Your baby should generally nurse every 2 to 3 hours and should not sleep for more than 4 hours at a time.
  • Check with your doctor or hospital emergency room right away if your baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, difficulty breathing, or limpness. These may be symptoms of an overdose and need immediate medical attention.

Do not suddenly stop taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping completely. This may help prevent a possible worsening of your condition and reduce the possibility of withdrawal symptoms such as restlessness, chills, muscle pain, runny nose, sweating, tearing of the eyes, or yawning.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

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 doctor or dentist gives you certain medicines without knowing that you have been taking butalbital or codeine.

Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

Using too much of this medicine may cause infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.