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Limitations of Use Because of the u01 white round of addiction, abuse, and misusewith opioids, even at recommended doses [see WARNINGS ], reserve hydrocodone bitartrate and acetaminophen tablets for use in patients for whom alternative treatment options [e. Each tablet contains 5 mg hydrocodone bitartrate and mg acetaminophen.

If you are a consumer or patient please visit this version. Addiction, Abuse, and Misuse Hydrocodone bitartrate and acetaminophen tablets exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of hydrocodone bitartrate and acetaminophen tablets. Monitor for respiratory depression, especially during initiation of hydrocodone bitartrate and acetaminophen tablets or following a dose increase [see WARNINGS ].

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If you are a consumer or patient please visit this version. 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 4, milligrams per day, and often involve more than one acetaminophen-containing product see WARNINGS. 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. It has the following structural formula:. Hydrocodone bitartrate and acetaminophen tablets USP, for oral administration, are available in a variety of strengths as described in the following table. Each hydrocodone bitartrate and acetaminophen tablet contains:. In addition each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch and stearic acid. Hydrocodone is a semisynthetic narcotic analgesic and antitussive with multiple actions qualitatively similar to those of codeine.

Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed hydrocodone bitartrate and acetaminophen tablets.

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If you are a consumer or patient please visit this version. Addiction, Abuse, and Misuse Hydrocodone bitartrate and acetaminophen tablets exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of hydrocodone bitartrate and acetaminophen tablets. Monitor for respiratory depression, especially during initiation of hydrocodone bitartrate and acetaminophen tablets or following a dose increase [see WARNINGS ]. Accidental Ingestion Accidental ingestion of hydrocodone bitartrate and acetaminophen tablets, especially by children, can result in a fatal overdose of Hydrocodone bitartrate and acetaminophen tablets [see WARNINGS ]. Neonatal Opioid Withdrawal Syndrome Prolonged use of hydrocodone bitartrate and acetaminophen tablets 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.

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Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped, or when breast-feeding is stopped. Labeler - Proficient Rx LP This Medication Guide has been approved by the U. In addition, abuse of opioids can occur in the absence of true addiction. Hydrocodone Following a 10 mg oral dose of hydrocodone administered to five adult male subjects, the mean peak concentration was Muscle Relaxants Hydrocodone Bitartrate and Acetaminophen Tablets may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death. Advise patients and caregivers that when medicines are no longer needed, they should be disposed of promptly. 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. Limitations of Use Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS ], reserve hydrocodone bitartrate and acetaminophen tablets for use in patients for whom alternative treatment options [e. This product should not be administered to patients who have previously exhibited hypersensitivity to hydrocodone or acetaminophen. Other opioids may be tried as some cases reported use of a different opioid without recurrence of adrenal insufficiency. The usual adult dosage is one or two tablets every four to six hours as needed for pain.

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DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of hydrocodone bitartrate and acetaminophen tablets, the risk is greatest during the initiation of therapy or following a dosage increase. The usual precautions should be observed and the possibility of respiratory depression should be kept in mind. When you first start taking hydrocodone bitartrate and acetaminophen tablets, 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. If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death. Clinically, dosage is titrated to provide adequate analgesia and may be limited by adverse reactions, including respiratory and CNS depression. The use of Hydrocodone Bitartrate and Acetaminophen Tablets in patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment is contraindicated. Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. In addition, abuse of opioids can occur in the absence of true addiction. 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. Diuretics Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone. Accidental ingestion of even one dose of hydrocodone bitartrate and acetaminophen tablets, especially by children, can result in respiratory depression and death due to an overdose of hydrocodone and acetaminophen.