Label: HYDROCODONE BITARTRATE AND ACETAMINOPHEN tablet

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: CIII
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 27, 2010

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  • DESCRIPTION

    Hydrocodone bitartrate and acetaminophen is supplied in tablet form for oral administration.

    Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula:

    This is an image of the structural formula of Hydrocodone bitartrate.

    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:

    This is an image of the structural formula of Acetaminophen.

    Hydrocodone Bitartrate and Acetaminophen Tablets, USP 2.5 mg/500 mg

    Each tablet contains:

        Hydrocodone Bitartrate.............2.5 mg
        Acetaminophen.........................500 mg

    In addition each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, FD&C Red #3, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch, stearic acid, and sucrose.  Meets USP Dissolution Test 1.

    Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/325 mg

    Each tablet contains:

        Hydrocodone Bitartrate.................5 mg
        Acetaminophen.............................325 mg

    In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, sodium lauryl sulfate, stearic acid and sugar spheres which are composed of starch derived from corn, FD&C Red #40, FD&C Yellow #6, and sucrose.  Meets USP Dissolution Test 2.

    Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/500 mg

    Each tablet contains:

        Hydrocodone Bitartrate.............5 mg
        Acetaminophen.........................500 mg

    In addition each tablet contains the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, and sodium starch glycolate.  Meets USP Dissolution Test 1.

    Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/325 mg

    Each tablet contains:

        Hydrocodone Bitartrate.............7.5 mg
        Acetaminophen.........................325 mg

    In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, FD&C Red #40 aluminum lake, FD&C Yellow #6 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, sodium lauryl sulfate, stearic acid. Meets USP Dissolution Test 2.

    Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/500 mg

    Each tablet contains:

        Hydrocodone Bitartrate.............7.5 mg
        Acetaminophen.........................500 mg

    In addition each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, FD&C Blue #1, FD&C Yellow #5, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch, stearic acid, and sucrose.  Meets USP Dissolution Test 1.

    Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/650 mg

    Each tablet contains:

        Hydrocodone Bitartrate.............7.5 mg
        Acetaminophen.........................650 mg

    In addition each tablet contains the following inactive ingredients: croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch, and stearic acid.  Meets USP Dissolution Test 1.

    Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/750 mg

    Each tablet contains:

        Hydrocodone Bitartrate.............7.5 mg
        Acetaminophen.........................750 mg

    In addition each tablet contains the following inactive ingredients: croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch, and stearic acid.  Meets USP Dissolution Test 1.

    Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg

    Each tablet contains:

        Hydrocodone Bitartrate............10 mg
        Acetaminophen.........................325 mg

    In addition each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, D&C Yellow #10 lake, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch, and stearic acid.  Meets USP Dissolution Test 1.

    Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg

    Each tablet contains:

        Hydrocodone Bitartrate............10 mg
        Acetaminophen.........................500 mg

    In addition each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, D&C Red #27 aluminum lake, D&C Red #30 aluminum lake, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch, and stearic acid.  Meets USP Dissolution Test 1.

    Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/650 mg

    Each tablet contains:

        Hydrocodone Bitartrate............10 mg
        Acetaminophen.........................650 mg

    In addition each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, FD&C Blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch, and stearic acid.  Meets USP Dissolution Test 1.

    Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/660 mg

    Each tablet contains:

        Hydrocodone Bitartrate............10 mg
        Acetaminophen.........................660 mg

    In addition each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch, and stearic acid.  Meets USP Dissolution Test 1.

  • CLINICAL PHARMACOLOGY

    Hydrocodone is a semisynthetic narcotic analgesic and antitussive with multiple actions qualitatively similar to those of codeine. Most of these involve the central nervous system and smooth muscle. The precise mechanism of action of hydrocodone and other opiates is not known, although it is believed to relate to the existence of opiate receptors in the central nervous system. In addition to analgesia, narcotics may produce drowsiness, changes in mood and mental clouding.

    The analgesic action of acetaminophen involves peripheral influences, but the specific mechanism is as yet undetermined. Antipyretic activity is mediated through hypothalamic heat regulating centers. Acetaminophen inhibits prostaglandin synthetase. Therapeutic doses of acetaminophen have negligible effects on the cardiovascular or respiratory systems; however, toxic doses may cause circulatory failure and rapid, shallow breathing.

    Pharmacokinetics:

    The behavior of the individual components is described below.

    Hydrocodone:

    Following a 10 mg oral dose of hydrocodone administered to five adult male subjects, the mean peak concentration was 23.6 ± 5.2 ng/mL. Maximum serum levels were achieved at 1.3 ± 0.3 hours and the half-life was determined to be 3.8 ± 0.3 hours. Hydrocodone exhibits a complex pattern of metabolism including O-demethylation, N-demethylation and 6-ketoreduction to the corresponding 6-α- and 6-β-hydroxymetabolites. 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

    Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain.

  • CONTRAINDICATIONS

    This product should not be administered to patients who have previously exhibited hypersensitivity to hydrocodone or acetaminophen.

    Patients known to be hypersensitive to other opioids may exhibit cross-sensitivity to hydrocodone.

  • WARNINGS

    Respiratory Depression:

    At high doses or in sensitive patients, hydrocodone may produce dose-related respiratory depression by acting directly on the brain stem respiratory center. Hydrocodone also affects the center that controls respiratory rhythm, and may produce irregular and periodic breathing.

    Head Injury and Increased Intracranial Pressure:

    The respiratory depressant effects of narcotics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a preexisting increase in intracranial pressure. Furthermore, narcotics produce adverse reactions which may obscure the clinical course of patients with head injuries.

    Acute Abdominal Conditions:

    The administration of narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions.

    Misuse, Abuse, and Diversion of Opioids:

    Hydrocodone bitartrate and acetaminophen tablets contain hydrocodone, an opioid agonist, and is a Schedule III controlled substance. Opioid agonists have the potential for being abused and are sought by abusers and people with addiction disorders, and are subject to diversion.

    Hydrocodone bitartrate and acetaminophen tablets can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing hydrocodone bitartrate and acetaminophen tablets in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion (see DRUG ABUSE AND DEPENDENCE).

  • PRECAUTIONS

    General:

    Special Risk Patients:

    As with any narcotic analgesic agent, hydrocodone bitartrate and acetaminophen tablets should be used with caution in elderly or debilitated patients, and those with severe impairment of hepatic or renal function, hypothyroidism, Addison's disease, prostatic hypertrophy or urethral stricture. The usual precautions should be observed and the possibility of respiratory depression should be kept in mind.

    Cough Reflex:

    Hydrocodone suppresses the cough reflex; as with all narcotics, caution should be exercised when hydrocodone bitartrate and acetaminophen tablets are used postoperatively and in patients with pulmonary disease.

    Hydrocodone Bitartrate and Acetaminophen Tablets 7.5 mg/500 mg contain FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

    Information for Patients:

    Hydrocodone, like all narcotics, may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery; patients should be cautioned accordingly.

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

    Hydrocodone 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.

    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:

    Patients receiving other narcotic analgesics, antihistamines, antipsychotics, antianxiety agents, or other CNS depressants (including alcohol) concomitantly with hydrocodone bitartrate and acetaminophen tablets may exhibit an additive CNS depression. When combined therapy is contemplated, the dose of one or both agents should be reduced.

    The use of MAO inhibitors or tricyclic antidepressants with hydrocodone preparations may increase the effect of either the antidepressant or hydrocodone.

    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 hydrocodone or acetaminophen have a potential for carcinogenesis, mutagenesis, or impairment of fertility.

    Pregnancy:

    Teratogenic Effects:

    Pregnancy Category C:

    There are no adequate and well-controlled studies in pregnant women. Hydrocodone bitartrate and acetaminophen tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

    Nonteratogenic Effects:

    Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent. The withdrawal signs include irritability and excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting, and fever. The intensity of the syndrome does not always correlate with the duration of maternal opioid use or dose. There is no consensus on the best method of managing withdrawal.

    Labor and Delivery:

    As with all narcotics, administration of hydrocodone bitartrate and acetaminophen tablets to the mother shortly before delivery may result in some degree of respiratory depression in the newborn, especially if higher doses are used.

    Nursing Mothers:

    Acetaminophen is excreted in breast milk in small amounts, but the significance of its effects on nursing infants is not known. It is not known whether hydrocodone is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from hydrocodone and acetaminophen, 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 have not been established.

    Geriatric Use:

    Clinical studies of hydrocodone bitartrate and acetaminophen tablets 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.

    Hydrocodone and the major metabolites of acetaminophen are known to be substantially excreted by the kidney. Thus the risk of toxic reactions may be greater in patients with impaired renal function due to the accumulation of the parent compound and/or metabolites in the plasma. 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.

    Hydrocodone may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of hydrocodone bitartrate and acetaminophen tablets and observed closely.

  • ADVERSE REACTIONS

    The most frequently reported adverse reactions are lightheadedness, dizziness, sedation, 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:

    Central Nervous System: Drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, psychic dependence, mood changes.

    Gastrointestinal System: Prolonged administration of hydrocodone bitartrate and acetaminophen tablets may produce constipation.

    Genitourinary System: Ureteral spasm, spasm of vesical sphincters and urinary retention have been reported with opiates.

    Respiratory Depression: Hydrocodone bitartrate may produce dose-related respiratory depression by acting directly on the brain stem respiratory centers (see OVERDOSAGE).

    Special Senses: Cases of hearing impairment or permanent loss have been reported predominantly in patients with chronic overdose.

    Dermatological: Skin rash, pruritus.

    The following adverse drug events may be borne in mind as potential effects of acetaminophen: allergic reactions, rash, thrombocytopenia, agranulocytosis.

    Potential effects of high dosage are listed in the OVERDOSAGE section.

  • DRUG ABUSE AND DEPENDENCE

    Misuse, Abuse, and Diversion of Opioids:

    Hydrocodone bitartrate and acetaminophen tablets contain hydrocodone, an opioid agonist, and is a Schedule III controlled substance. Hydrocodone bitartrate and acetaminophen tablets, and other opioids, used in analgesia can be abused and are subject to criminal diversion.

    Addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. Drug addiction is a treatable disease utilizing a multidisciplinary approach, but relapse is common.

    "Drug seeking" behavior is very common in addicts and drug abusers. 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 physician(s). "Doctor shopping" to obtain additional prescriptions is common among drug abusers and people suffering from untreated addiction.

    Abuse and addiction are separate and distinct from physical dependence and tolerance. Physical dependence usually assumes clinically significant dimensions only after several weeks of continued opioid use, although a mild degree of physical dependence may develop after a few days of opioid therapy. Tolerance, in which increasingly large doses are required in order to produce the same degree of analgesia, is manifested initially by a shortened duration of analgesic effect, and subsequently by decreases in the intensity of analgesia. The rate of development of tolerance varies among patients. Physicians should be aware that abuse of opioids can occur in the absence of true addiction and is characterized by misuse for non-medical purposes, often in combination with other psychoactive substances. Hydrocodone bitartrate and acetaminophen tablets, like other opioids, may be diverted for non-medical use. Record-keeping of prescribing information, including quantity, frequency, and renewal requests 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.

  • OVERDOSAGE

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

    Signs and Symptoms:

    Hydrocodone:

    Serious overdose with hydrocodone is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension. In severe overdosage, apnea, circulatory collapse, cardiac arrest and death may occur.

    Acetaminophen:

    In acetaminophen overdosage: dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necrosis, 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.

    Treatment:

    A single or multiple overdose with hydrocodone and acetaminophen 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. Vasopressors and other supportive measures should be employed as indicated. A cuffed endotracheal tube should be inserted before gastric lavage of the unconscious patient and, when necessary, to provide assisted respiration.

    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.

    Naloxone, a narcotic antagonist, can reverse respiratory depression and coma associated with opioid overdose. Naloxone hydrochloride 0.4 mg to 2 mg is given parenterally. Since the duration of action of hydrocodone may exceed that of the naloxone, the patient should be kept under continuous surveillance and repeated doses of the antagonist should be administered as needed to maintain adequate respiration. A narcotic antagonist should not be administered in the absence of clinically significant respiratory or cardiovascular depression.

    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.

    The toxic dose for acetaminophen for adults is 10 g.

  • DOSAGE AND ADMINISTRATION

    Dosage should be adjusted according to the severity of the pain and the response of the patient. However, it should be kept in mind that tolerance to hydrocodone can develop with continued use and that the incidence of untoward effects is dose related.

    Hydrocodone Bitartrate and Acetaminophen Tablets, USP 2.5 mg/500 mg

    The usual adult dosage is one or two tablets every four to six hours as needed for pain. The total daily dosage should not exceed 8 tablets.

    Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/325 mg

    The usual adult dosage is one or two tablets every four to six hours as needed for pain. The total daily dosage should not exceed 12 tablets.

    Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/500 mg

    The usual adult dosage is one or two tablets every four to six hours as needed for pain. The total daily dosage should not exceed 8 tablets.

    Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/325 mg

    The usual adult dosage is one tablet every four to six hours as needed for pain. The total daily dosage should not exceed 6 tablets.

    Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/500 mg

    The usual adult dosage is one tablet every four to six hours as needed for pain. The total daily dosage should not exceed 6 tablets.

    Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/650 mg

    The usual adult dosage is one tablet every four to six hours as needed for pain. The total daily dosage should not exceed 6 tablets.

    Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/750 mg

    The usual adult dosage is one tablet every four to six hours as needed for pain. The total daily dosage should not exceed 5 tablets.

    Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg

    The usual adult dosage is one tablet every four to six hours as needed for pain. The total daily dosage should not exceed 6 tablets.

    Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg

    The usual adult dosage is one tablet every four to six hours as needed for pain. The total daily dosage should not exceed 6 tablets.

    Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/650 mg

    The usual adult dosage is one tablet every four to six hours as needed for pain. The total daily dosage should not exceed 6 tablets.

    Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/660 mg

    The usual adult dosage is one tablet every four to six hours as needed for pain. The total daily dosage should not exceed 6 tablets.

  • HOW SUPPLIED

    Hydrocodone Bitartrate and Acetaminophen Tablets, USP 2.5 mg/500 mg

    are supplied as white with bright pink specks, capsule-shaped, scored tablets, debossed "3591", on one side and debossed "V" on the reverse side.

    Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/325 mg

    are supplied as white with orange specks, capsule­-shaped, scored tablets, debossed “3604” on one side and debossed “V” on the reverse side.

    Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/500 mg

    are supplied as white, capsule-shaped, scored tablets, debossed "3592", on one side and debossed "V" on the reverse side.

    Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/325 mg

    are supplied as light orange, oval­shaped, scored tablets, debossed “3605” on one side and debossed “V” on the reverse side.

    Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/500 mg

    are supplied as white with green specks, capsule-shaped, scored tablets, debossed "3594" on one side and debossed "V" on the reverse side.

    Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/650 mg

    are supplied as white, modified capsule-shaped, scored tablets, debossed "3595" on one side and debossed "V" on the reverse side.

    Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/750 mg

    are supplied as white capsule-shaped, scored tablets, debossed "3596" on one side and debossed "V" on the reverse side.

    Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg

    are supplied as light yellow, modified capsule-shaped, scored tablets, debossed "3601" on one side and debossed "V" on the reverse side.

    Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg

    are supplied as pink, capsule-shaped tablets, debossed "3600" on one side and debossed "V" on the reverse side.

    Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/650 mg

    are supplied as light blue, capsule-shaped, scored tablets, debossed "3597" on one side and debossed "V" on the reverse side.

    Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/660 mg

    are supplied as white oval-shaped, scored tablets, debossed "3598" on one side and debossed "V" on the reverse side.

    They are supplied by Altura Pharmaceuticals, Inc. as follows:

    NDCStrengthQuantity/FormColorSource Prod. Code
    63874-203-20500 mg / 5 mg20 Tablets in a Plastic BottleWHITE0603-3881
    63874-203-30500 mg / 5 mg30 Tablets in a Plastic BottleWHITE0603-3881
    63874-203-60500 mg / 5 mg60 Tablets in a Plastic BottleWHITE0603-3881
    63874-203-90500 mg / 5 mg90 Tablets in a Plastic BottleWHITE0603-3881
    63874-203-01500 mg / 5 mg100 Tablets in a Plastic BottleWHITE0603-3881
    63874-295-30500 mg / 7.5 mg30 Tablets in a Plastic Bottlewith green specks0603-3882
    63874-295-60500 mg / 7.5 mg60 Tablets in a Plastic Bottlewith green specks0603-3882
    63874-295-90500 mg / 7.5 mg90 Tablets in a Plastic Bottlewith green specks0603-3882
    63874-295-01500 mg / 7.5 mg100 Tablets in a Plastic Bottlewith green specks0603-3882
    63874-230-30750 mg / 7.5 mg30 Tablets in a Plastic BottleWHITE0603-3883
    63874-230-60750 mg / 7.5 mg60 Tablets in a Plastic BottleWHITE0603-3883
    63874-230-90750 mg / 7.5 mg90 Tablets in a Plastic BottleWHITE0603-3883
    63874-230-01750 mg / 7.5 mg100 Tablets in a Plastic BottleWHITE0603-3883
    63874-230-04750 mg / 7.5 mg120 Tablets in a Plastic BottleWHITE0603-3883
    63874-834-30325 mg / 10 mg30 Tablets in a Plastic Bottlelight yellow0603-3887
    63874-834-60325 mg / 10 mg60 Tablets in a Plastic Bottlelight yellow0603-3887
    63874-834-90325 mg / 10 mg90 Tablets in a Plastic Bottlelight yellow0603-3887
    63874-834-01325 mg / 10 mg100 Tablets in a Plastic Bottlelight yellow0603-3887
    63874-834-04325 mg / 10 mg120 Tablets in a Plastic Bottlelight yellow0603-3887
    63874-293-30500 mg / 10 mg30 Tablets in a Plastic BottlePINK0603-3888
    63874-293-60500 mg / 10 mg60 Tablets in a Plastic BottlePINK0603-3888
    63874-293-90500 mg / 10 mg90 Tablets in a Plastic BottlePINK0603-3888
    63874-293-01500 mg / 10 mg100 Tablets in a Plastic BottlePINK0603-3888
    63874-861-30650 mg / 10 mg30 Tablets in a Plastic Bottlelight blue0603-3885
    63874-861-60650 mg / 10 mg60 Tablets in a Plastic Bottlelight blue0603-3885
    63874-861-90650 mg / 10 mg90 Tablets in a Plastic Bottlelight blue0603-3885
    63874-861-01650 mg / 10 mg100 Tablets in a Plastic Bottlelight blue0603-3885
    63874-279-30660 mg / 10 mg30 Tablets in a Plastic BottleWHITE0603-3886
    63874-279-60660 mg / 10 mg60 Tablets in a Plastic BottleWHITE0603-3886
    63874-279-90660 mg / 10 mg90 Tablets in a Plastic BottleWHITE0603-3886
    63874-279-01660 mg / 10 mg100 Tablets in a Plastic BottleWHITE0603-3886

    Storage:

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

    Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.

    A Schedule CIII Narcotic.

  • SPL UNCLASSIFIED SECTION

    Manufactured by:
    QUALITEST PHARMACEUTICALS
    Huntsville, AL 35811

    This Product is Repackaged By:

    Altura Pharmaceuticals, Inc.
    12540 McCann Drive
    Santa Fe Springs, CA 90670
    United States

  • PRINCIPAL DISPLAY PANEL

    This is an image of the label for 5 mg/500 mg Hydrocodone Bitartrate and Acetaminophen Tablets.
  • PRINCIPAL DISPLAY PANEL

    This is an image of the label for 7.5 mg/500 mg Hydrocodone Bitartrate and Acetaminophen Tablets.
  • PRINCIPAL DISPLAY PANEL

    This is an image of the label for 7.5 mg/750 mg Hydrocodone Bitartrate and Acetaminophen Tablets.
  • PRINCIPAL DISPLAY PANEL

    This is an image of the label for 10 mg/325 mg Hydrocodone Bitartrate and Acetaminophen Tablets.
  • PRINCIPAL DISPLAY PANEL

    This is an image of the label for 10 mg/500 mg Hydrocodone Bitartrate and Acetaminophen Tablets.
  • PRINCIPAL DISPLAY PANEL

    This is an image of the label for 10 mg/650 mg Hydrocodone Bitartrate and Acetaminophen Tablets.
  • PRINCIPAL DISPLAY PANEL

    This is an image of the label for 10 mg/660 mg Hydrocodone Bitartrate and Acetaminophen Tablets.
  • INGREDIENTS AND APPEARANCE
    HYDROCODONE BITARTRATE AND ACETAMINOPHEN 
    hydrocodone bitartrate and acetaminophen tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63874-203(NDC:0603-3881)
    Route of AdministrationORALDEA ScheduleCIII    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    HYDROCODONE BITARTRATE (UNII: NO70W886KK) (HYDROCODONE - UNII:6YKS4Y3WQ7) HYDROCODONE BITARTRATE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSE (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorWHITEScore2 pieces
    ShapeOVAL (capsule-shaped) Size17mm
    FlavorImprint Code 3592;V
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63874-203-2020 in 1 BOTTLE, PLASTIC
    2NDC:63874-203-3030 in 1 BOTTLE, PLASTIC
    3NDC:63874-203-6060 in 1 BOTTLE, PLASTIC
    4NDC:63874-203-9090 in 1 BOTTLE, PLASTIC
    5NDC:63874-203-01100 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA08997101/01/2010
    HYDROCODONE BITARTRATE AND ACETAMINOPHEN 
    hydrocodone bitartrate and acetaminophen tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63874-295(NDC:0603-3882)
    Route of AdministrationORALDEA ScheduleCIII    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    HYDROCODONE BITARTRATE (UNII: NO70W886KK) (HYDROCODONE - UNII:6YKS4Y3WQ7) HYDROCODONE BITARTRATE7.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CROSPOVIDONE (UNII: 68401960MK)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorWHITE (with green specks) Score2 pieces
    ShapeOVAL (capsule-shaped) Size17mm
    FlavorImprint Code 3594;V
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63874-295-3030 in 1 BOTTLE, PLASTIC
    2NDC:63874-295-6060 in 1 BOTTLE, PLASTIC
    3NDC:63874-295-9090 in 1 BOTTLE, PLASTIC
    4NDC:63874-295-01100 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04014401/01/2010
    HYDROCODONE BITARTRATE AND ACETAMINOPHEN 
    hydrocodone bitartrate and acetaminophen tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63874-230(NDC:0603-3883)
    Route of AdministrationORALDEA ScheduleCIII    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN750 mg
    HYDROCODONE BITARTRATE (UNII: NO70W886KK) (HYDROCODONE - UNII:6YKS4Y3WQ7) HYDROCODONE BITARTRATE7.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CROSPOVIDONE (UNII: 68401960MK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorWHITEScore2 pieces
    ShapeOVAL (capsule-shaped) Size17mm
    FlavorImprint Code 3596;V
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63874-230-3030 in 1 BOTTLE, PLASTIC
    2NDC:63874-230-6060 in 1 BOTTLE, PLASTIC
    3NDC:63874-230-9090 in 1 BOTTLE, PLASTIC
    4NDC:63874-230-01100 in 1 BOTTLE, PLASTIC
    5NDC:63874-230-04120 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04015701/01/2010
    HYDROCODONE BITARTRATE AND ACETAMINOPHEN 
    hydrocodone bitartrate and acetaminophen tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63874-834(NDC:0603-3887)
    Route of AdministrationORALDEA ScheduleCIII    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    HYDROCODONE BITARTRATE (UNII: NO70W886KK) (HYDROCODONE - UNII:6YKS4Y3WQ7) HYDROCODONE BITARTRATE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CROSPOVIDONE (UNII: 68401960MK)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorYELLOW (light yellow) Score2 pieces
    ShapeOVAL (modified capsule-shaped) Size14mm
    FlavorImprint Code 3601;V
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63874-834-3030 in 1 BOTTLE, PLASTIC
    2NDC:63874-834-6060 in 1 BOTTLE, PLASTIC
    3NDC:63874-834-9090 in 1 BOTTLE, PLASTIC
    4NDC:63874-834-01100 in 1 BOTTLE, PLASTIC
    5NDC:63874-834-04120 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04035501/01/2010
    HYDROCODONE BITARTRATE AND ACETAMINOPHEN 
    hydrocodone bitartrate and acetaminophen tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63874-293(NDC:0603-3888)
    Route of AdministrationORALDEA ScheduleCIII    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    HYDROCODONE BITARTRATE (UNII: NO70W886KK) (HYDROCODONE - UNII:6YKS4Y3WQ7) HYDROCODONE BITARTRATE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CROSPOVIDONE (UNII: 68401960MK)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeOVAL (capsule-shaped) Size17mm
    FlavorImprint Code 3600;V
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63874-293-3030 in 1 BOTTLE, PLASTIC
    2NDC:63874-293-6060 in 1 BOTTLE, PLASTIC
    3NDC:63874-293-9090 in 1 BOTTLE, PLASTIC
    4NDC:63874-293-01100 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04035601/01/2010
    HYDROCODONE BITARTRATE AND ACETAMINOPHEN 
    hydrocodone bitartrate and acetaminophen tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63874-861(NDC:0603-3885)
    Route of AdministrationORALDEA ScheduleCIII    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
    HYDROCODONE BITARTRATE (UNII: NO70W886KK) (HYDROCODONE - UNII:6YKS4Y3WQ7) HYDROCODONE BITARTRATE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CROSPOVIDONE (UNII: 68401960MK)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorBLUE (light blue) Score2 pieces
    ShapeOVAL (capsule-shaped) Size16mm
    FlavorImprint Code 3597;V
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63874-861-3030 in 1 BOTTLE, PLASTIC
    2NDC:63874-861-6060 in 1 BOTTLE, PLASTIC
    3NDC:63874-861-9090 in 1 BOTTLE, PLASTIC
    4NDC:63874-861-01100 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04014301/01/2010
    HYDROCODONE BITARTRATE AND ACETAMINOPHEN 
    hydrocodone bitartrate and acetaminophen tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63874-279(NDC:0603-3886)
    Route of AdministrationORALDEA ScheduleCIII    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN660 mg
    HYDROCODONE BITARTRATE (UNII: NO70W886KK) (HYDROCODONE - UNII:6YKS4Y3WQ7) HYDROCODONE BITARTRATE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CROSPOVIDONE (UNII: 68401960MK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorWHITEScore2 pieces
    ShapeOVAL (oval-shaped) Size18mm
    FlavorImprint Code 3598;V
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63874-279-3030 in 1 BOTTLE, PLASTIC
    2NDC:63874-279-6060 in 1 BOTTLE, PLASTIC
    3NDC:63874-279-9090 in 1 BOTTLE, PLASTIC
    4NDC:63874-279-01100 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04035801/01/2010
    Labeler - Altura Pharmaceuticals, Inc. (006890545)
    Establishment
    NameAddressID/FEIBusiness Operations
    Altura Pharmaceuticals, Inc.006890545repack, relabel