Butalbital, Acetaminophen, Caffeine, And Codeine Phosphate (Fioricet With Codeine)

Trade Name : Fioricet with Codeine

Actavis Pharma, Inc.

CAPSULE

Strength 503004030 mg/1mg/1mg/1mg/1

BUTALBITAL; ACETAMINOPHEN; CAFFEINE; CODEINE PHOSPHATE Barbiturates [CS],Barbiturate [EPC],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE],Full Opioid Agonists [MoA],Opioid Agonist [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Butalbital, Acetaminophen, Caffeine, And Codeine Phosphate (Fioricet With Codeine) which is also known as Fioricet with Codeine and Manufactured by Actavis Pharma, Inc.. It is available in strength of 50; 300; 40; 30 mg/1; mg/1; mg/1; mg/1 per ml. Read more

Butalbital, Acetaminophen, Caffeine, And Codeine Phosphate (Fioricet With Codeine) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Arrayn- Addiction, Abuse, and Misuse
  • u00a0FIORICET with CODEINE exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patientu2019s risk prior to prescribing u00a0FIORICET with CODEINE, and monitor all patients regularly for the development of these behaviors and conditions .
  • Arrayn- Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS):
  • To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products [n n- Array
  • Healthcare providers are strongly encouraged to
  • Arrayn- Life-Threatening Respiratory Depression
  • Serious, life-threatening, or fatal respiratory depression may occur with use of FIORICET with CODEINE. Monitor for respiratory depression, especially during initiation of FIORICET with CODEINE or following a dose increase .
  • Arrayn- Accidental Ingestion
  • Accidental ingestion of even one dose of u00a0FIORICET with CODEINE, especially by children, can result in a fatal overdose of FIORICET with CODEINE.
  • Arrayn- Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants
  • Concomitant use of opioids or a barbiturate with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death .
  • Arrayn- Ultra-Rapid Metabolism of Codeine and Other Risk Factors for Life-threatening Respiratory Depression in Children
  • Life-threatening respiratory depression and death have occurred in children who received codeine. Most of the reported cases occurred following tonsillectomy and/or adenoidectomy, and many of the children had evidence of being an ultra-rapid metabolizer of codeine due to a CYP2D6 polymorphism . FIORICET with CODEINE is contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy . Avoid the use of FIORICET with CODEINE in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of codeine.
  • Arrayn- Neonatal Opioid Withdrawal Syndrome
  • Prolonged use of FIORICET with CODEINE during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available .
  • Arrayn- Interactions with Drugs Affecting Cytochrome P450 Isoenzymes
  • The effects of concomitant use or discontinuation of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with codeine are complex. Use of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with FIORICET with CODEINE requires careful consideration of the effects on codeine, and the active metabolite, morphine .
  • Arrayn- Hepatotoxicity
  • FIORICET with CODEINE contains acetaminophen. 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 4,000 milligrams per day, and often involve more than one acetaminophen-containing product .
  • WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; ULTRA-RAPID METABOLISM OF CODEINE AND OTHER RISK FACTORS FOR LIFE-THREATENING RESPIRATORY DEPRESSION IN CHILDREN; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES; and HEPATOTOXICITY
  • See full prescribing information for complete boxed warning.
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  • Dosage and Administration ()u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 10/2019Warnings and Precautions (, )u00a0u00a0u00a0u00a0u00a010/2019
  • FIORICET with CODEINE is indicated for the management of the symptom complex of tension (or muscle contraction) headache when non-opioid analgesic and alternative treatments are inadequate.
  • Limitations of Use
  • u00a0n- [see Warnings and Precautions ()],
  • FIORICET with CODEINE is a combination product of butalbital, a barbiturate; acetaminophen; caffeine, a methylxanthine; and codeine phosphate, an opioid agonist; and is indicated for the management of the symptom complex of tension (or muscle contraction) headache, when other non-opioid analgesic and alternative treatments are inadequate. ()
  • Limitations of Use
  • u00a0
  • Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserveu00a0 FIORICET with CODEINE for use in patients for whom alternative treatment options (e.g., non-opioid, non-barbiturate analgesics):
  • No data
  • Capsules: Butalbital 50 mg, Acetaminophen 300 mg, Caffeine 40 mg, Codeine Phosphate 30 mgNavy blue, opaque cap with a gray, opaque body.u00a0 Cap is imprinted with u201cFIORICETu201d and u201cCODEINEu201d in blue and body is imprinted with four-head profile in red.
  • Capsules: 50 mg butalbital, 300 mg acetaminophen, 40 mg caffeine, and 30 mg codeine phosphate.
  • FIORICET with CODEINE is contraindicated for:
  • FIORICET with CODEINE is also contraindicated in patients with:
  • No data
  • The following serious adverse reactions are described, or described in greater detail, in other sections:
  • The following adverse reactions associated with the use of butalbital, acetaminophen, caffeine, and codeine phosphate were identified in clinical studies or post-marketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
  • Frequently Observed
  • The most frequently reported adverse reactions were 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
  • Autonomic Nervous
  • Gastrointestinal
  • Cardiovascularn- :
  • Musculoskeletal:
  • Genitourinary:
  • Miscellaneous
  • The following adverse reactions have been voluntarily reported as temporally associated with Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, a related product containing aspirin, butalbital, caffeine, and codeine phosphate.
  • Central Nervous
  • Autonomic Nervous
  • Gastrointestinal
  • Cardiovascular
  • Skin
  • Urinary
  • Miscellaneous
  • The following adverse reactions have been reported with the components of FIORICET with CODEINE. Potential effects of high dosage are listed in the OVERDOSAGE section.
  • Acetaminophen
  • Caffeine
  • Codeine
  • Several cases of dermatological reactions, including toxic epidermal necrolysis and erythema multiforme, have been reported for butalbital, acetaminophen, and caffeine tablets, USP.
  • Serotonin syndrome
  • Adrenal insufficiency
  • Androgen deficiencyn- [see Clinical Pharmacology ()]
  • Frequently reported adverse reactions are drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, abdominal pain, and intoxicated feeling. ()
  • Table 1 includes clinically significant drug interactions with FIORICET with CODEINE.
  • Table 1: Clinically Significant Drug Interactions with FIORICET with CODEINE
  • Serotonergic Drugs:n- 7
  • Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics:n- 7
  • No data
  • Pregnancy
  • Lactationn- 8.2
  • Geriatric
  • No data
  • Clinical Presentation
  • Acute overdose with FIORICET with CODEINE can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypotension, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations .
  • Signs and Symptoms
  • Symptoms attributable to acute barbiturate poisoning include drowsiness, confusion, and coma; respiratory depression; hypotension; and hypovolemic shock.
  • Toxicity from codeine poisoning includes the opioid triad of: pinpoint pupils, depression of respiration, and loss of consciousness. Convulsions may occur.
  • 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. Acute caffeine poisoning may cause insomnia, restlessness, tremor, and delirium, tachycardia, and extrasystoles.
  • Treatment of Overdose
  • In case of overdose, priorities are the re-establishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed. Employ other supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias will require advanced life-support techniques.
  • The opioid antagonists, naloxone or nalmefene, are specific antidotes to respiratory depression resulting from opioid overdose. For clinically significant respiratory or circulatory depression secondary to codeine phosphate overdose, administer an opioid antagonist. Opioid antagonists should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to codeine overdose.
  • Because the duration of opioid reversal is expected to be less than the duration of action of codeine in FIORICET with CODEINE, carefully monitor the patient until spontaneous respiration is reliably re-established. If the response to an opioid antagonist is suboptimal or only brief in nature, administer additional antagonist as directed by the productu2019s prescribing information.
  • In an individual physically dependent on opioids, administration of the recommended usual dosage of the antagonist will precipitate an acute withdrawal syndrome. The severity of the withdrawal symptoms experienced will depend on the degree of physical dependence and the dose of the antagonist administered. If a decision is made to treat serious respiratory depression in the physically dependent patient, administration of the antagonist should be begun with care and by titration with smaller than usual doses of the antagonist.
  • A single or multiple drug overdose with FIORICET with CODEINE 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. For respiratory depression due to overdosage or unusual sensitivity to codeine, parenteral naloxone is a specific and effective antagonist.
  • 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.
  • FIORICET with CODEINE (butalbital, acetaminophen, caffeine, and codeine phosphate) is supplied in capsule form for oral administration. Each capsule contains:
  • Butalbital, USPu2026u2026u2026u2026..........50 mg
  • Acetaminophen, USPu2026u2026u2026...300 mg
  • Caffeine, USPu2026u2026u2026u2026u2026........40 mg
  • Codeine phosphate, USPu2026.......30 mg
  • 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.u00a0 It has the following structural formula:
  • Caffeine (1,3,7-trimethylxanthine), a methylxanthine, is a central nervous system stimulant. It has the following structural formula:
  • Codeine phosphate (7,8-Didehydro-4,5u03b1-epoxy-3-methoxy-17-methylmorphinan-6u03b1-ol phosphate (1:1)(salt) hemihydrate) is an opioid agonist. It has the following structural formula:
  • Inactive Ingredients:
  • No data
  • Carcinogenesis
  • Long-term studies in animals to evaluate the carcinogenic potential of the combination of butalbital, acetaminophen, caffeine, and codeine or butalbital alone have not been conducted.
  • Two-year carcinogenicity studies with codeine sulfate have been conducted in F344/N rats and B6C3F1 mice. There was no evidence of carcinogenicity in male and female rats, respectively, at dietary doses up to 70 and 80 mg/kg/day of codeine sulfate (approximately 4 times the maximum recommended daily dose of 180 mg/day for adults on a mg/m basis) for two years. Similarly there was no evidence of carcinogenicity activity in male and female mice at dietary doses up to 400 mg/kg/day of codeine sulfate (approximately 10 times the maximum recommended daily dose of 180 mg/day for adults on a mg/m basis) for two years.
  • Long-term studies in mice and rats have been completed by the National Toxicology Program to evaluate the carcinogenic potential of acetaminophen. In 2-year feeding studies, F344/N rats and B6C3F1 mice were fed a diet containing acetaminophen up to 6000 ppm. Female rats demonstrated equivocal evidence of carcinogenic activity based on increased incidences of mononuclear cell leukemia at 1.6 times the maximum human daily dose (MHDD) of 1950 mg/day, based on a body surface area comparison. In contrast, there was no evidence of carcinogenic activity in male rats that received up to 1.4 times or mice at up to 2.4 to 2.8 times the MHDD, based on a body surface area comparison.
  • In a 2-year study in Sprague-Dawley rats, caffeine (as caffeine base) administered in drinking water was not carcinogenic in male rats at doses up to 102 mg/kg or in female rats at doses up to 170 mg/kg (approximately 4 and 7 times, respectively, the maximum human daily dose on a mg/m basis). In an 18-month study in C57BL/6 mice, no evidence of tumorigenicity was seen at dietary doses up to 55 mg/kg (equivalent to the MHDD on a mg/m basis).
  • Mutagenesis
  • There are no genetic toxicology data for butalbital.
  • Codeine sulfate was not mutagenic in the in vitro bacterial reverse mutation assay or clastogenic in the in vitro Chinese hamster ovary cell chromosome aberration assay.
  • In the published literature, acetaminophen has been reported to be clastogenic when administered at 1500 mg/kg/day to the rat model (7.2-times the MHDD, based on a body surface area comparison). In contrast, no clastogenicity was noted at a dose of 750 mg/kg/day (3.6-times the MHDD, based on a body surface area comparison), suggesting a threshold effect.
  • Caffeine (as caffeine base) increased the sister chromatid exchange (SCE) SCE/cell metaphase (exposure time dependent) in an in vivo mouse metaphase analysis. Caffeine also potentiated the genotoxicity of known mutagens and enhanced the micronuclei formation (5-fold) in folate-deficient mice. However, caffeine did not increase chromosomal aberrations in in vitro Chinese hamster ovary cell (CHO) and human lymphocyte assays and was not mutagenic in an in vitro CHO/hypoxanthine guanine phosphoribosyltransferase (HGPRT) gene mutation assay, except at cytotoxic concentrations. In addition, caffeine was not clastogenic in an in vivo mouse micronucleus assay. Caffeine was negative in the in vitro bacterial reverse mutation assay (Ames test).
  • Impairment of Fertility
  • No adequate studies have been conducted in animals to characterize the impact of the combinations of butalbital, acetaminophen, caffeine, and codeine on fertility. There are also no data on butalbital alone or codeine alone.
  • In studies conducted by the National Toxicology Program, fertility assessments with acetaminophen have been completed in Swiss CD-1 mice via a continuous breeding study. There were no effects on fertility parameters in mice consuming up to 3.4 times the MHDD of acetaminophen, based on a body surface area comparison. Although there was no effect on sperm motility or sperm density in the epididymis, there was a significant increase in the percentage of abnormal sperm in mice consuming 3.6 times the MHDD (based on a body surface comparison) and there was a reduction in the number of mating pairs producing a fifth litter at this dose, suggesting the potential for cumulative toxicity with chronic administration of acetaminophen near the upper limit of daily dosing.
  • Published studies in rodents report that oral acetaminophen treatment of male animals at doses that are 2.4 times the MHDD and greater (based on a body surface comparison) result in decreased testicular weights, reduced spermatogenesis, reduced fertility, and reduced implantation sites in females given the same doses. These effects appear to increase with the duration of treatment. The clinical significance of these findings is not known.
  • Caffeine (as caffeine base) administered to male rats at 50 mg/kg/day subcutaneously (2 times the MHDD on a mg/m basis) for 4 days prior to mating with untreated females, caused decreased male reproductive performance in addition to causing embryotoxicity. In addition, long-term exposure to high oral doses of caffeine (3 g over 7 weeks) was toxic to rat testes as manifested by spermatogenic cell degeneration.
  • FIORICET with CODEINE (Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules) is a navy blue opaque cap with a gray opaque body.u00a0 Cap is imprinted with u201cFIORICETu201d and u201cCODEINEu201d in blue and body is imprinted with four-head profile u00a0u00a0in red.
  • Bottles of 100 (NDC 52544-082-01)
  • Arrayn- Store and Dispense
  • Store at 20 to 25u00b0C (68 to 77u00b0F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.u00a0 Store FIORICET with CODEINE securely and dispose of properly n
  • Rx only
  • Keep this and all medication out of the reach of children.
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide).
  • Storage and Disposal
  • Because of the risks associated with accidental ingestion, misuse, and abuse, advise patients to store FIORICET with CODEINE securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home )]. Inform patients that leaving FIORICET with CODEINE unsecured can pose a deadly risk to others in the home.
  • Advise patients and caregivers that when medicines are no longer needed, they should be disposed of promptly. Inform patients that medicine take-back options are the preferred way to safely dispose of most types of unneeded medicines. If no take back programs or DEA-registered collectors are available, instruct patients to dispose of FIORICET with CODEINE by following these four steps:
  • Inform patients that they can visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.
  • Arrayn- Addiction, Abuse, and Misuse
  • Inform patients that the use of FIORICET with CODEINE, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death Instruct patients not to share FIORICET with CODEINE with others and to take steps to protect FIORICET with CODEINE from theft or misuse.
  • Life-Threatening Respiratory Depression
  • Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting FIORICET with CODEINE or when the dosage is increased, and that it can occur even at recommended dosages . Advise patients how to recognize respiratory depression and to seek medical attention if breathing difficulties develop.
  • Accidental Ingestion
  • Inform patients that accidental ingestion, especially in children, may result in respiratory depression or death.
  • Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants (Including Alcohol)
  • Inform patients and caregivers that potentially fatal additive effects may occur if FIORICET with CODEINE is used with benzodiazepines or other CNS depressants, including alcohol, and not to use these concomitantly unless supervised by a healthcare providern
  • Ultra-Rapid Metabolism of Codeine and Other Risk Factors for Life-threatening Respiratory Depression in Children
  • Advise caregivers that FIORICET with CODEINE is contraindicated in all children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. Advise caregivers of children 12-18 years of age receiving codeine to monitor for signs of respiratory depression .
  • Serotonin Syndrome
  • Inform patients that opioids could cause a rare but potentially life-threatening condition resulting from concomitant administration of serotonergic drugs. Warn patients of the symptoms of serotonin syndrome and to seek medical attention right away if symptoms develop. Instruct patients to inform their physicians if they are taking, or plan to take serotonergic medications. .
  • MAOI Interaction
  • Inform patients not to take FIORICET with CODEINE while using any drugs that inhibit monoamine oxidase. Patients should not start MAOIs while taking FIORICET with CODEINE ].
  • Adrenal Insufficiency
  • Inform patients that opioids could cause adrenal insufficiency, a potentially life-threatening condition. Adrenal insufficiency may present with non-specific symptoms and signs such as nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. Advise patients to seek medical attention if they experience a constellation of these symptoms .
  • Important Administration Instructions
  • Instruct patients how to properly take FIORICET with CODEINE, including the following:
  • Important Discontinuation Instructions
  • In order to avoid developing withdrawal symptoms, instruct patients not to discontinue FIORICET with CODEINE without first discussing a tapering plan with the prescriber n
  • Severe Hypotension
  • Inform patients that FIORICET with CODEINE may cause orthostatic hypotension and syncope. Instruct patients how to recognize symptoms of low blood pressure and how to reduce the risk of serious consequences should hypotension occur (e.g., sit or lie down, carefully rise from a sitting or lying position) .
  • Anaphylaxis
  • Inform patients that anaphylaxis has been reported with ingredients contained in FIORICET with CODEINE. Advise patients how to recognize such a reaction and when to seek medical attention n
  • Pregnancy
  • Neonatal Opioid Withdrawal Syndrome
  • Inform female patients of reproductive potential that prolonged use of FIORICET with CODEINE during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated n
  • Arrayn- Embryo-Fetal Toxicity
  • Inform female patients of reproductive potential that FIORICET with CODEINE can cause fetal harm and to inform their healthcare provider of a known or suspected pregnancy n
  • Lactation
  • Advise women that breastfeeding is not recommended during treatment with FIORICET with CODEINE .
  • Infertility
  • Inform patients that chronic use of opioids may cause reduced fertility. It is not known whether these effects on fertility are reversible n
  • Risks of Driving and Operating Heavy Machinery
  • Inform patients that FIORICET with CODEINE may impair the ability to perform potentially hazardous activities such as driving a car or operating heavy machinery. Advise patients not to perform such tasks until they know how they will react to the medication .
  • Constipation
  • Advise patients of the potential for severe constipation, including management instructions and when to seek medical attention .
  • Disposal of Unused FIORICET with CODEINE
  • Advise patients to properly dispose of unused u00a0FIORICET with CODEINE. Advise patients to throw the drug in the household trash following these steps. 1) Remove them from their original containers and mix them with an undesirable substance, such as used coffee grounds or kitty litter (this makes the drug less appealing to children and pets, and unrecognizable to people who may intentionally go through the trash seeking drugs). 2) Place the mixture in a sealable bag, empty can, or other container to prevent the drug from leaking or breaking out of a garbage bag, or to dispose of in accordance with the local state guidelines and/or regulations.
  • Manufactured by: Nexgen Pharma, Inc.Irvine, CA 92606
  • Distributed By:Actavis Pharma, Inc.Parsippany, NJ 07054 USA
  • Rev. 02/2020
  • This Medication Guide has been approved by the U.S. Food and Drug Administration. n
  • NDC 52544-082-01
  • Fioricetn with Codeineu00a0n- CIIIn- butalbital, acetaminophen, caffeine, and codeine phosphaten- Capsules
  • Each Capsule Contains:n- 300 mg
  • PHARMACIST: Dispense the accompanying Medication Guide to each patient.
  • 100 Capsules Rx only

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