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Capital & Codeine

Pronunciation

Generic Name: acetaminophen and codeine phosphate
Dosage Form: oral suspension

Rx Only

WARNING: RISK OF MEDICATION ERRORS; ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; HEPATOTOXICITY; DEATH RELATED TO ULTRA-RAPID METABOLISM OF CODEINE TO MORPHINE; and CYTOCHROME P450 3A4 INTERACTION

Risk of Medication Errors

Ensure accuracy when prescribing, dispensing, and administering CAPITAL® AND CODEINE ORAL SUSPENSION (120 mg acetaminophen/12 mg codeine phosphate per 5 mL). Dosing errors due to confusion between mg and mL, and other acetaminophen/codeine phosphate oral suspensions of different concentrations can result in accidental overdose and death [see WARNINGS, DOSAGE AND ADMINSTRATION].

Addiction, Abuse, and Misuse

CAPITAL® AND CODEINE ORAL SUSPENSION exposes patient and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing CAPITAL® AND CODEINE ORAL SUSPENSION, and monitor all patients regularly for the development of these behaviors or conditions [see WARNINGS].

Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of CAPITAL® AND CODEINE ORAL SUSPENSION. Monitor for respiratory depression, especially during initiation of CAPITAL® AND CODEINE ORAL SUSPENSION or following a dose increase [see WARNINGS].

Accidental Ingestion

Accidental ingestion of even one dose of CAPITAL® AND CODEINE ORAL SUSPENSION, especially by children, can result in a fatal overdose of CAPITAL® AND CODEINE ORAL SUSPENSION [see WARNINGS].

Neonatal Opioid Withdrawal Syndrome

Prolonged use of CAPITAL® AND CODEINE ORAL SUSPENSION 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 [see 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.

Death Related to Ultra-Rapid Metabolism of Codeine to Morphine

Respiratory depression and death have occurred in children who received codeine following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine due to a CYP2D6 polymorphism.

Cytochrome P450 3A4 Interaction

The concomitant use of CAPITAL® AND CODEINE ORAL SUSPENSION with all cytochrome P450 3A4 inhibitors may result in an increase in codeine plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in codeine plasma concentration. Monitor patients receiving CAPITAL® AND CODEINE ORAL SUSPENSION and any CYP3A4 inhibitor or inducer [see WARNINGS, PRECAUTIONS; Drug Interactions].

Capital & Codeine Description

CAPITAL® AND CODEINE ORAL SUSPENSION (Acetaminophen and codeine phosphate oral suspension) is pharmacologically classified as an analgesic.

Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:

C8H9NO2                                                     M.W.= 151.16

Codeine phosphate, 7,8-didehydro-4,5α-Epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula:

C18H21NO3•H3PO4•½H2O

M.W.= 406.37

Each 5 mL, for oral administration contains:

Acetaminophen

120 mg

Codeine Phosphate

12 mg

In addition the following inactive ingredients are present: Artificial fruit mint flavor, artificial punch flavor, citric acid, D&C Red #33, FD&C Red #40, magnesium aluminum silicate, methylparaben, polysorbate-80, propylene glycol, propylparaben, purified water, sodium benzoate, sorbitol, sucrose.

Capital & Codeine - Clinical Pharmacology

This product combines the analgesic effects of a centrally acting analgesic, codeine, with a peripherally acting analgesic, acetaminophen.

Pharmacokinetics

The behavior of the individual components is described below.

Codeine

Codeine is readily absorbed from the gastrointestinal tract. It is rapidly distributed from the intravascular spaces to the various body tissues, with preferential uptake by parenchymatous organs such as the liver, spleen and kidney. Codeine crosses the blood-brain barrier, and is found in fetal tissue and breast milk. The plasma concentration does not correlate with brain concentration or relief of pain; however, codeine is not bound to plasma proteins and does not accumulate in body tissues.

The plasma half-life is about 2.9 hours. The elimination of codeine is primarily via the kidneys, and about 90% of an oral dose is excreted by the kidneys within 24 hours of dosing. The urinary secretion products consist of free and glucuronide conjugated codeine (about 70%), free and conjugated norcodeine (about 10%), free and conjugated morphine (about 10%), normorphine (4%), and hydrocodone (1%). The remainder of the dose is excreted in the feces.

At therapeutic doses, the analgesic effect reaches a peak within 2 hours and persists between 4 and 6 hours.

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.

Indications and Usage for Capital & Codeine

CAPITAL® AND CODEINE ORAL SUSPENSION is indicated for the management of mild to moderate pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Limitations of Use

Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve CAPITAL® AND CODEINE ORAL SUSPENSION for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]

Have not been tolerated, or are not expected to be tolerated,
Have not provided adequate analgesia, or are not expected to provide adequate analgesia.

Contraindications

CAPITAL® AND CODEINE ORAL SUSPENSION is contraindicated in patients with:

Significant respiratory depression [see WARNINGS]
Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see WARNINGS]
Hypersensitivity to codeine or acetaminophen.

Codeine-containing products are contraindicated for postoperative pain management in children who have undergone tonsillectomy and/or adenoidectomy.

Warnings

Risk of Accidental Overdose and Death due to Medication Errors

Dosing errors can result in accidental overdose and death. Avoid dosing errors that may result from confusion between mg and mL and confusion with acetaminophen and codeine phosphate solutions of different concentrations, when prescribing, dispensing, and administering CAPITAL® AND CODEINE ORAL SUSPENSION. Ensure that the dose is communicated clearly and dispensed accurately.

Addiction, Abuse, and Misuse

CAPITAL® AND CODEINE ORAL SUSPENSION contains codeine phosphate and is a Schedule V controlled substance. As an opioid, codeine phosphate exposes users to the risks of addiction, abuse, and misuse [see DRUG ABUSE AND DEPENDENCE].

Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed CAPITAL® AND CODEINE ORAL SUSPENSION. Addiction can occur at recommended dosages and if the drug is misused or abused.

Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing CAPITAL® AND CODEINE ORAL SUSPENSION, and monitor all patients receiving CAPITAL® AND CODEINE ORAL SUSPENSION for the development of these behaviors or conditions. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). The potential for these risks should not, however, prevent the proper management of pain in any given patient. Patients at increased risk may be prescribed opioids such as CAPITAL® AND CODEINE ORAL SUSPENSION, but use in such patients necessitates intensive counseling about the risks and proper use of CAPITAL® AND CODEINE ORAL SUSPENSION along with intensive monitoring for signs of addiction, abuse, and misuse.

Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Consider these risks when prescribing or dispensing CAPITAL® AND CODEINE ORAL SUSPENSION. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper disposal of unused drug [see PRECAUTIONS; Information for Patients]. Contact local state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product.

Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death. Management of respiratory depression may include close observation, supportive measures, and use of opioid antagonists, depending on the patient’s clinical status [see OVERDOSAGE]. Carbon dioxide (CO2) retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids.

While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of CAPITAL® AND CODEINE ORAL SUSPENSION, the risk is greatest during the initiation of therapy or following a dosage increase. Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy with and following dosage increases of CAPITAL® AND CODEINE ORAL SUSPENSION.

To reduce the risk of respiratory depression, proper dosing and titration of CAPITAL® AND CODEINE ORAL SUSPENSION are essential [see DOSAGE AND ADMINISTRATION]. Overestimating the CAPITAL® AND CODEINE ORAL SUSPENSION dosage when converting patients from another opioid product can result in a fatal overdose with the first dose.

Accidental ingestion of even one dose of CAPITAL® AND CODEINE ORAL SUSPENSION, especially by children, can result in respiratory depression and death due to an overdose of codeine.

Neonatal Opioid Withdrawal Syndrome

Prolonged use of CAPITAL® AND CODEINE ORAL SUSPENSION during pregnancy can result in withdrawal in the neonate. Neonatal opioid withdrawal syndrome, unlike opioid withdrawal syndrome in adults, 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 [see PRECAUTIONS; Information for Patients, Pregnancy].

Risks of Concomitant Use or Discontinuation of Cytochrome P450 3A4 Inhibitors and Inducers

Concomitant use of CAPITAL® AND CODEINE ORAL SUSPENSION with a CYP3A4 inhibitor, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g., ritonavir), may increase plasma concentrations of codeine and prolong opioid adverse reactions, which may cause potentially fatal respiratory depression [see WARNINGS], particularly when an inhibitor is added after a stable dose of CAPITAL® AND CODEINE ORAL SUSPENSION is achieved. Similarly, discontinuation of a CYP3A4 inducer, such as rifampin, carbamazepine, and phenytoin, in CAPITAL® AND CODEINE ORAL SUSPENSION-treated patients may increase codeine plasma concentrations and prolong opioid adverse reactions. When using CAPITAL® AND CODEINE ORAL SUSPENSION with CYP3A4 inhibitors or discontinuing CYP3A4 inducers in CAPITAL® AND CODEINE ORAL SUSPENSION-treated patients, monitor patients closely at frequent intervals and consider dosage reduction of CAPITAL® AND CODEINE ORAL SUSPENSION until stable drug effects are achieved [see PRECAUTIONS; Drug Interactions].

Concomitant use of CAPITAL® AND CODEINE ORAL SUSPENSION with CYP3A4 inducers or discontinuation of an CYP3A4 inhibitor could decrease codeine plasma concentrations, decrease opioid efficacy or, possibly, lead to a withdrawal syndrome in a patient who had developed physical dependence to CAPITAL® AND CODEINE ORAL SUSPENSION. When using CAPITAL® AND CODEINE ORAL SUSPENSION with CYP3A4 inducers or discontinuing CYP3A4 inhibitors, monitor patients closely at frequent intervals and consider increasing the opioid dosage if needed to maintain adequate analgesia or if symptoms of opioid withdrawal occur [see PRECAUTIONS; Drug Interactions].

Risks due to Interactions with Central Nervous System Depressants

Hypotension, profound sedation, respiratory depression, coma, and death may result if CAPITAL® AND CODEINE ORAL SUSPENSION is used concomitantly with alcohol or other central nervous system (CNS) depressants (e.g., benzodiazepines and other sedatives/hypnotics, anxiolytics, and tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids).

When considering the use of CAPITAL® AND CODEINE ORAL SUSPENSION in a patient taking a CNS depressant, assess the duration of use of the CNS depressant and the patient’s response, including the degree of tolerance that has developed to CNS depression. Additionally, evaluate the patient’s use of alcohol or illicit drugs that can cause CNS depression. If the decision to begin CAPITAL® AND CODEINE ORAL SUSPENSION is made, start with a lower dosage of CAPITAL® AND CODEINE ORAL SUSPENSION, monitor patients for signs of respiratory depression, sedation, and hypotension, and consider using a lower dose of the concomitant CNS depressant [see PRECAUTIONS; Drug Interactions].

Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients

The use of CAPITAL® AND CODEINE ORAL SUSPENSION in patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment is contraindicated.

Patients with Chronic Pulmonary Disease: CAPITAL® AND CODEINE ORAL SUSPENSION-treated patients with significant chronic obstructive pulmonary disease or cor pulmonale, and those with a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression are at increased risk of decreased respiratory drive including apnea, even at recommended dosages of CAPITAL® AND CODEINE ORAL SUSPENSION [see WARNINGS].

Elderly, Cachectic, or Debilitated Patients: Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients because they may have altered pharmacokinetics or altered clearance compared to younger, healthier patients [see WARNINGS].

Monitor such patients closely, particularly when initiating and titrating CAPITAL® AND CODEINE ORAL SUSPENSION and when CAPITAL® AND CODEINE ORAL SUSPENSION is given concomitantly with other drugs that depress respiration [see WARNINGS]. Alternatively, consider the use of non-opioid analgesics in these patients.

Adrenal Insufficiency

Cases of adrenal insufficiency have been reported with opioid use, more often following greater than 1 month of use. Presentation of adrenal insufficiency may include non-specific symptoms and signs including nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. If adrenal insufficiency is suspected, confirm the diagnosis with diagnostic testing as soon as possible. If adrenal insufficiency is diagnosed, treat with physiologic replacement doses of corticosteroids. Wean the patient off of the opioid to allow adrenal function to recover and continue corticosteroid treatment until adrenal function recovers. Other opioids may be tried as some cases reported use of a different opioid without recurrence of adrenal insufficiency. The information available does not identify any particular opioids as being more likely to be associated with adrenal insufficiency.

Head Injury and Increased Cranial Pressure

In the presence of head injury or other intracranial lesions, the respiratory depressant effects of codeine and other narcotics may be markedly enhanced, as well as their capacity for elevating cerebrospinal fluid pressure. Narcotics also produce other CNS depressant effects, such as drowsiness, that may further obscure the clinical course of the patients with head injuries.

Abdominal Conditions

Codeine or other narcotics may obscure signs on which to judge the diagnosis or clinical course of patients with acute abdominal conditions.

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 skin reactions and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.

Death Related to Ultra-Rapid Metabolism of Codeine to Morphine

Respiratory depression and death have occurred in children who received codeine in the post-operative period following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine (i.e., multiple copies of the gene for cytochrome P450 isoenzyme 2D6 or high morphine concentrations). Deaths have also occurred in nursing infants who are exposed to high levels of morphine in breast milk because their mothers were ultra-rapid metabolizers of codeine [see PRECAUTIONS; Nursing Mothers].

Some individuals may be ultra-rapid metabolizers because of a specific CYP2D6 genotype (gene duplications denoted as *1/*1xN or *1/*2xN). The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0.5 to 1% in Chinese and Japanese, 0.5 to 1% in Hispanics, 1 to 10% in Caucasians, 3% in African Americans, and 16 to 28% in North Africans, Ethiopians, and Arabs. Data are not available for other ethnic groups. These individuals convert codeine into its active metabolite, morphine, more rapidly and completely than other people. This rapid conversion results in higher than expected serum morphine levels. Even at labeled dosage regimens, individuals who are ultra-rapid metabolizers may have life-threatening or fatal respiratory depression or experience signs of overdose (such as extreme sleepiness, confusion, or shallow breathing) [see OVERDOSAGE].

Children with obstructive sleep apnea who are treated with codeine for post-tonsillectomy and/or adenoidectomy pain may be particularly sensitive to the respiratory depressant effects of codeine that has been rapidly metabolized to morphine. Codeine-containing products are contraindicated for post-operative pain management in all pediatric patients undergoing tonsillectomy and/or adenoidectomy [see CONTRAINDICATIONS].

When prescribing codeine-containing products, healthcare providers should choose the lowest effective dose for the shortest period of time and inform patients and caregivers about these risks and the signs of morphine overdose [see OVERDOSAGE].

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 CAPITAL® AND CODEINE ORAL SUSPENSION immediately and seek medical care if they experience these symptoms. Do not prescribe CAPITAL® AND CODEINE ORAL SUSPENSION for patients with acetaminophen allergy.

Precautions

General

CAPITAL® AND CODEINE ORAL SUSPENSION 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, head injuries, elevated intracranial pressure, acute abdominal conditions, hypothyroidism, urethral stricture, Addison's disease, or prostatic hypertrophy.

Information for Patients

Do not take CAPITAL® AND CODEINE ORAL SUSPENSION if you are allergic to any of its ingredients.
If you develop signs of allergy such as a rash or difficulty breathing stop taking CAPITAL® AND CODEINE ORAL SUSPENSION 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.
Impairment of Mental or Physical Ability

Inform patients that codeine 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.

Ultra-Rapid Metabolism of Codeine to Morphine

Advise patients that some people have a genetic variation that results in codeine changing into morphine more rapidly and completely than other people. Most people are unaware of whether they are an ultra-rapid codeine metabolizer or not. These higher-than-normal levels of morphine in the blood may lead to life-threatening or fatal respiratory depression or signs of overdose such as extreme sleepiness, confusion, or shallow breathing. Children with this genetic variation who were prescribed codeine after tonsillectomy and/or adenoidectomy for obstructive sleep apnea may be at greatest risk based on reports of several deaths in this population due to respiratory depression. Codeine-containing products are contraindicated in all children who undergo tonsillectomy and/or adenoidectomy. Advise caregivers of children receiving codeine-containing products for other reasons to monitor for signs of respiratory depression.

Medication Errors

Instruct patients how to measure and take the correct dose of CAPITAL® AND CODEINE ORAL SUSPENSION, and to always use the applicable dose delivery device when administering CAPITAL® AND CODEINE ORAL SUSPENSION to ensure the dose is measured and administered accurately [see WARNINGS].

If the prescribed concentration is changed, instruct patients on how to correctly measure the new dose to avoid errors which could result in accidental overdose and death.

Addiction, Abuse, and Misuse

Inform patients that the use of CAPITAL® AND CODEINE ORAL SUSPENSION, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death [see WARNINGS]. Instruct patients not to share CAPITAL® AND CODEINE ORAL SUSPENSION with others and to take steps to protect CAPITAL® AND CODEINE ORAL SUSPENSION 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 CAPITAL® AND CODEINE ORAL SUSPENSION or when the dosage is increased, and that it can occur even at recommended dosages [see WARNINGS]. Advise patients how to recognize respiratory depression and to seek medical attention if breathing difficulties develop.

Accidental Ingestion

Inform patients that accidental ingestion, especially by children, may result in respiratory depression or death [see WARNINGS]. Instruct patients to take steps to store CAPITAL® AND CODEINE ORAL SUSPENSION securely.

Interactions with Alcohol and Other CNS Depressants

Inform patients that potentially serious additive effects may occur if CAPITAL® AND CODEINE ORAL SUSPENSION is used with alcohol or other CNS depressants and not to use such drugs unless supervised by a health care provider [see WARNINGS, PRECAUTIONS; Drug Interactions].

Serotonin Syndrome

Inform patients that CAPITAL® AND CODEINE ORAL SUSPENSION 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 [see PRECAUTIONS; Drug Interactions].

Adrenal Insufficiency

Inform patients that CAPITAL® AND CODEINE ORAL SUSPENSION 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 [see WARNINGS].

Pregnancy

Neonatal Opioid Withdrawal Syndrome

Inform patients that prolonged use of CAPITAL® AND CODEINE ORAL SUSPENSION during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated [see WARNINGS, PRECAUTIONS; Pregnancy]

Embryo-Fetal Toxicity

Inform female patients of reproductive potential that CAPITAL® AND CODEINE ORAL SUSPENSION can cause fetal harm and to inform the prescriber of a known or suspected pregnancy [see PRECAUTIONS; Pregnancy].

Lactation

Advise nursing mothers to monitor infants for increased sleepiness (more than usual), breathing difficulties, or limpness. Instruct nursing mothers to seek immediate medical care if they notice these signs [see PRECAUTIONS; Nursing Mothers].

Disposal of Unused CAPITAL® AND CODEINE ORAL SUSPENSION

Advise patients to safely throw away any product that is unused or out of date.

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

CYP3A4

Inhibitor

The concomitant use of CAPITAL® AND CODEINE ORAL SUSPENSION and CYP3A4 inhibitors, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g. ketoconazole), and protease inhibitors (e.g., ritonavir), can increase the plasma concentration of codeine, resulting in increased or prolonged opioid effects. These effects could be more pronounced with concomitant use of CAPITAL® AND CODEINE ORAL SUSPENSION and CYP3A4 inhibitors, particularly when an inhibitor is added after a stable dose of CAPITAL® AND CODEINE ORAL SUSPENSION is achieved [see WARNINGS].

After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, the codeine plasma concentration will decrease, resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to CAPITAL® AND CODEINE ORAL SUSPENSION.

If concomitant use is necessary, consider dosage reduction of CAPITAL® AND CODEINE ORAL SUSPENSION until stable drug effects are achieved. Monitor patients for respiratory depression and sedation at frequent intervals. If a CYP3A4 inhibitor is discontinued, consider increasing the CAPITAL® AND CODEINE ORAL SUSPENSION dosage until stable drug effects are achieved [see DOSAGE AND ADMINISTRATION]. Monitor for signs of opioid withdrawal.

Inducer

The concomitant use of CAPITAL® AND CODEINE ORAL SUSPENSION and CYP3A4 inducers, such as rifampin, carbamazepine, and phenytoin, can decrease the plasma concentration of codeine, resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence to CAPITAL® AND CODEINE ORAL SUSPENSION [see WARNINGS].

After stopping a CYP3A4 inducer, as the effects of the inducer decline, the codeine plasma concentration will increase, which could increase or prolong both the therapeutic effects and adverse reactions, and may cause serious respiratory depression.

If concomitant use is necessary, consider increasing the CAPITAL® AND CODEINE ORAL SUSPENSION dosage until stable drug effects are achieved [see DOSAGE AND ADMINISTRATION]. Monitor for signs of opioid withdrawal. If a CYP3A4 inducer is discontinued, consider CAPITAL® AND CODEINE ORAL SUSPENSION dosage reduction and monitor for signs of respiratory depression.

Central Nervous System Depressants

Due to additive pharmacologic effect, the concomitant use of CNS depressants such as alcohol, benzodiazepines and other sedative hypnotics, anxiolytics, and tranquilizers, muscle relaxants, general anesthetics, antipsychotics, and other opioids, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death.

Consider dose reduction of one or both drugs. Monitor patients for signs of respiratory depression, sedation, and hypotension [see WARNINGS].

Serotonergic Drugs

The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system, such as selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that effect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), and monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue), has resulted in serotonin syndrome [see PRECAUTIONS; Information for Patients].

If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Discontinue CAPITAL® AND CODEINE ORAL SUSPENSION if serotonin syndrome is suspected.

Drug/Laboratory Test Interactions

Codeine may increase serum amylase levels.

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 and codeine have a potential for carcinogenesis or mutagenesis.

Acetaminophen and codeine have been found to have no mutagenic potential using the Ames Salmonella-Microsomal Activation test, the Basc test on Drosophila germ cells, and the Micronucleus test on mouse bone marrow.

Infertility

No adequate studies have been conducted in animals to determine whether acetaminophen has a potential for impairment of fertility. Chronic use of opioids may cause reduced fertility in females and males of reproductive potential. It is not known whether these effects on fertility are reversible [see ADVERSE REACTIONS].

Pregnancy

Teratogenic Effects

Codeine

A study in rats and rabbits reported no teratogenic effect of codeine administered during the period of organogenesis in doses ranging from 5 to 120 mg/kg. In the rat, doses at the 120 mg/kg level, in the toxic range for the adult animal, were associated with an increase in embryo resorption at the time of implantation. In another study a single 100 mg/kg dose of codeine administered to pregnant mice reportedly resulted in delayed ossification in the offspring.

There are no adequate and well-controlled studies in pregnant women. Acetaminophen and codeine phosphate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Fetal/Neonatal Adverse Reactions

Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth.

Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea and failure to gain weight. The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. Observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly [see WARNINGS].

Labor or Delivery

Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. An opioid antagonist, such as naloxone, must be available for reversal of opioid-induced respiratory depression in the neonate. CAPITAL® AND CODEINE ORAL SUSPENSION is not recommended for use in pregnant women during or immediately prior to labor, when other analgesic techniques are more appropriate. Opioid analgesics, including CAPITAL® AND CODEINE ORAL SUSPENSION, can prolong labor through actions which temporarily reduce the strength, duration, and frequency of uterine contractions. However, this effect is not consistent and may be offset by an increased rate of cervical dilation, which tends to shorten labor. Monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression.

Nursing Mothers

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

Codeine is secreted into human milk. In women with normal codeine metabolism (normal CYP2D6 activity), the amount of codeine secreted into human milk is low and dose-dependent. Despite the common use of codeine products to manage postpartum pain, reports of adverse events in infants are rare. However, some women are ultra-rapid metabolizers of codeine. These women achieve higher-than-expected serum levels of codeine's active metabolite, morphine, leading to higher-than-expected levels of morphine in breast milk and potentially dangerously high serum morphine levels in their breastfed infants. Therefore, maternal use of codeine can potentially lead to serious adverse reactions, including death, in nursing infants [see WARNINGS; Death Related to Ultra-Rapid Metabolism of Codeine to Morphine].

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for CAPITAL® AND CODEINE ORAL SUSPENSION and any potential adverse effects on the breastfed infant from CAPITAL® AND CODEINE ORAL SUSPENSION or from the underlying maternal condition.

Infants exposed to CAPITAL® AND CODEINE ORAL SUSPENSION through breast milk should be monitored for excess sedation and respiratory depression. Withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped, or when breast-feeding is stopped.

Pediatric Use

Safe dosage of acetaminophen and codeine phosphate oral suspension has not been established in pediatric patients below the age of 3 years.

Geriatric Use

Elderly patients (aged 65 years or older) may have increased sensitivity to CAPITAL® AND CODEINE ORAL SUSPENSION. In general, use caution when selecting a dosage for an elderly patient, 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.

Respiratory depression is the chief risk for elderly patients treated with opioids, and has occurred after large initial doses were administered to patients who were not opioid-tolerant or when opioids were co-administered with other agents that depress respiration. Titrate the dosage of CAPITAL® AND CODEINE ORAL SUSPENSION slowly in geriatric patients [see WARNINGS].

Adverse Reactions

The most frequently reported adverse reactions are drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea and vomiting. These effects seem to be more prominent in ambulatory than in nonambulatory patients, and some of these adverse reactions may be alleviated if the patient lies down.

Other adverse reactions include allergic reactions, euphoria, dysphoria, constipation, abdominal pain, pruritus, rash, thrombocytopenia, agranulocytosis, adrenal insufficiency, serotonin syndrome.

At higher doses codeine has most of the disadvantages of morphine including respiratory depression.

Androgen deficiency

Chronic use of opioids may influence the hypothalamic-pituitary-gonadal axis, leading to androgen deficiency that may manifest as symptoms of hypogonadism, such as impotence, erectile dysfunction, or amenorrhea. The causal role of opioids in the syndrome of hypogonadism is unknown because the various medical, physical, lifestyle, and psychological stressors that may influence gonadal hormone levels have not been adequately controlled for in studies conducted to date. Patients presenting with symptoms of androgen deficiency should undergo laboratory evaluation.

To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals North America at 1-800-556-1937 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Abuse and Dependence

Controlled Substance

CAPITAL® AND CODEINE ORAL SUSPENSION contains codeine phosphate, and is a Schedule V controlled substance.

Abuse

CAPITAL® AND CODEINE ORAL SUSPENSION contains codeine phosphate, a substance with a high potential for abuse similar to other opioids including hydrocodone, oxycodone, and morphine. CAPITAL® AND CODEINE ORAL SUSPENSION can be abused and is subject to misuse, addiction, and criminal diversion [see WARNINGS].

All patients treated with opioids require careful monitoring for signs of abuse and addiction, since use of opioid analgesic products carries the risk of addiction even under appropriate medical use.

Prescription drug abuse is the intentional non-therapeutic use of a prescription drug, even once, for its rewarding psychological or physiological effects.

Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that develop after repeated substance use and includes: a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful consequences, a higher priority given to drug use than to other activities and obligations, increased tolerance, and sometimes a physical withdrawal.

“Drug-seeking” behavior is very common in persons with substance use disorders. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing, or referral, repeated “loss” of prescriptions, tampering with prescriptions and reluctance to provide prior medical records or contact information for other treating health care provider(s). “Doctor shopping” (visiting multiple prescribers) to obtain additional prescriptions is common among drug abusers and people suffering from untreated addiction. Preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with poor pain control.

Abuse and addiction are separate and distinct from physical dependence and tolerance. Health care providers should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. In addition, abuse of opioids can occur in the absence of true addiction.

CAPITAL® AND CODEINE ORAL SUSPENSION, like other opioids, can be diverted for non-medical use into illicit channels of distribution. Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised.

Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.

Dependence

Both tolerance and physical dependence can develop during chronic opioid therapy. Tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). Tolerance may occur to both the desired and undesired effects of drugs, and may develop at different rates for different effects.

Physical dependence results in withdrawal symptoms after abrupt discontinuation or a significant dosage reduction of a drug. Withdrawal also may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone, nalmefene), mixed agonist/antagonist analgesics (pentazocine, butorphanol, nalbuphine), or partial agonists (buprenorphine). Physical dependence may not occur to a clinically significant degree until after several days to weeks of continued opioid usage.

CAPITAL® AND CODEINE ORAL SUSPENSION should not be abruptly discontinued [see DOSAGE AND ADMINISTRATION]. If CAPITAL® AND CODEINE ORAL SUSPENSION is abruptly discontinued in a physically-dependent patient, a withdrawal syndrome may occur. Some or all of the following can characterize this syndrome: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. Other signs and symptoms also may develop, including irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate.

Infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal signs [see PRECAUTIONS; Pregnancy].

Overdosage

Following an acute overdosage, toxicity may result from codeine or acetaminophen.

Clinical Presentation

Acute overdose 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. 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.

Treatment of Overdose

A single or multiple drug overdose with acetaminophen and 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.

In case of overdose, priorities are the reestablishment 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 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 CAPITAL® AND CODEINE ORAL SUSPENSION, 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 product’s 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. 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.

Capital & Codeine Dosage and Administration

Important Dosage and Administration Instructions

Ensure accuracy when prescribing, dispensing, and administering CAPITAL® AND CODEINE ORAL SUSPENSION to avoid dosing errors due to confusion between mg and mL, and with other acetaminophen/codeine solutions of different concentrations, which could result in accidental overdose and death. Ensure the proper dose is communicated and dispensed. When writing prescriptions, include both the total dose in mg and the total dose in volume.

Initiate the dosing regimen for each patient individually, taking into account the patient's severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse [see WARNINGS].

Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy and following dosage increases with CAPITAL® AND CODEINE ORAL SUSPENSION and adjust the dosage accordingly [see WARNINGS].

Initial Dosage

CAPITAL® AND CODEINE ORAL SUSPENSION (Acetaminophen and codeine phosphate oral suspension) contains 120 mg of acetaminophen and 12 mg of codeine phosphate per 5 mL (teaspoonful) and is given orally.

The recommended dose of codeine phosphate in children is 0.5 mg/kg body weight.

The usual doses are:

Children: (7 to 12 years): 10 mL (2 teaspoonfuls) 3 or 4 times daily.

(3 to 6 years): 5 mL (1 teaspoonful) 3 or 4 times daily.

(under 3 years): safe dosage has not been established.

Adults: 15 mL (1 tablespoonful) every 4 hours as needed.

Titration and Maintenance of Therapy

Individually titrate CAPITAL® AND CODEINE ORAL SUSPENSION to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving CAPITAL® AND CODEINE ORAL SUSPENSION to assess the maintenance of pain control and the relative incidence of adverse reactions, as well as monitoring for the development of addiction, abuse, or misuse [see WARNINGS]. Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration.

If the level of pain increases after dosage stabilization, attempt to identify the source of increased pain before increasing the CAPITAL® AND CODEINE ORAL SUSPENSION dosage. If unacceptable opioid-related adverse reactions are observed, consider reducing the dosage. Adjust the dosage to obtain an appropriate balance between management of pain and opioid-related adverse reactions.

Discontinuation of CAPITAL® AND CODEINE ORAL SUSPENSION

When a patient who has been taking CAPITAL® AND CODEINE ORAL SUSPENSION regularly and may be physically dependent no longer requires therapy with CAPITAL® AND CODEINE ORAL SUSPENSION, use a gradual downward titration of the dosage to prevent signs and symptoms of withdrawal. Do not stop CAPITAL® AND CODEINE ORAL SUSPENSION abruptly [see WARNINGS, DRUG ABUSE AND DEPENDENCE].

How is Capital & Codeine Supplied

CAPITAL® AND CODEINE ORAL SUSPENSION is a fruit punch-flavored, pink suspension available in 16 fluid oz. bottles, NDC 0187-0003-01.

SHAKE WELL BEFORE USING.

STORAGE

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

Packaging and Storage

Preserve in tight, light-resistant containers and label "Shake Well Before Using."

Manufactured by:
Hi-Tech Pharmacal Co., Inc.
Amityville, NY 11701 USA

Manufactured for:
Valeant Pharmaceuticals North America LLC
Bridgewater, NJ 08807 USA

Medication Guide

Capital® and Codeine (kap-i-tl and koh-deen)

(Acetaminophen and Codeine Phosphate Oral Suspension USP), CV

Capital and Codeine is:

A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage mild to moderate pain severe enough to require an opioid, when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them.
An opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.

Important information about Capital and Codeine:

Get emergency help right away if you take too much Capital and Codeine (overdose). When you first start taking Capital and Codeine, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur.
Never give anyone else your Capital and Codeine. They could die from taking it. Store Capital and Codeine away from children and in a safe place to prevent stealing or abuse. Selling or giving away Capital and Codeine is against the law.

Do not take Capital and Codeine if you have:

severe asthma, trouble breathing, or other lung problems.
a bowel blockage or have narrowing of the stomach or intestines.
allergy to codeine or acetaminophen.

Before taking Capital and Codeine, tell your healthcare provider if you have a history of:

head injury, seizures ● liver, kidney, thyroid problems
problems urinating ● pancreas or gallbladder problems
abuse of street or prescription drugs, alcohol addiction, or mental health problems.

Tell your healthcare provider if you are:

pregnant or planning to become pregnant. Prolonged use of Capital and Codeine during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
breastfeeding. Capital and Codeine passes into breast milk and may harm your baby.
taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking Capital and Codeine with certain other medicines can cause serious side effects that could lead to death.

When taking Capital and Codeine:

Do not change your dose. Take Capital and Codeine exactly as prescribed by your healthcare provider.
Always use an accurate milliliter measuring device to correctly measure your dose.
Take your prescribed dose only as directed. Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time.
Call your healthcare provider if the dose you are taking does not control your pain.
If you have been taking Capital and Codeine regularly, do not stop taking Capital and Codeine without talking to your healthcare provider.
After you stop taking Capital and Codeine, it should be safely thrown away.

While taking Capital and Codeine DO NOT:

Drive or operate heavy machinery, until you know how Capital and Codeine affects you. Capital and Codeine can make you sleepy, dizzy, or lightheaded.
Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with Capital and Codeine may cause you to overdose and die.

The possible side effects of Capital and Codeine:

constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe.

Get emergency medical help if you have:

trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.

These are not all the possible side effects of Capital and Codeine. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov.

Manufactured by: Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701 USA

Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA

www.valeant.com or call 1-800-321-4576

This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued: 04/2016

PRINCIPAL DISPLAY PANEL - 120 mg / 12 mg Bottle Label

NDC 0187-0003-01

(NON-ALCOHOLIC)

Capital® and
Codeine CV

(Acetaminophen and Codeine
Phosphate Oral Suspension USP)

Rx Only

16 fl oz

Each 5 mL (one
teaspoonful) contains
120 mg Acetaminophen
USP and 12 mg Codeine
Phosphate USP

Oral
Suspension

"SHAKE WELL
BEFORE USING"

VALEANT

CAPITAL AND CODEINE 
acetaminophen and codeine phosphate suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0187-0003
Route of Administration ORAL DEA Schedule CV    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Acetaminophen (Acetaminophen) Acetaminophen 120 mg  in 5 mL
Codeine Phosphate (Codeine Anhydrous) Codeine Phosphate 12 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE  
D&C RED NO. 33  
FD&C RED NO. 40  
MAGNESIUM ALUMINUM SILICATE  
METHYLPARABEN  
POLYSORBATE 80  
PROPYLENE GLYCOL  
PROPYLPARABEN  
WATER  
SODIUM BENZOATE  
SORBITOL  
SUCROSE  
Product Characteristics
Color      Score     
Shape Size
Flavor FRUIT PUNCH Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:0187-0003-01 473 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA086024 05/03/2004
Labeler - Valeant Pharmaceuticals International (042230623)
Establishment
Name Address ID/FEI Operations
Hi-Tech Pharmacal Co., Inc. 101196749 MANUFACTURE(0187-0003)
Revised: 10/2014
 
Valeant Pharmaceuticals International
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