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If you are a consumer or patient please visit this version. Addiction, Abuse, and Misuse Hydrocodone bitartrate and acetaminophen 7house exposes patients and other users to the risks of opioid addiction, white oval tablet u03, abuse, and misuse, which can lead to overdose and death.

Risk cannot be ruled out during pregnancy. What is the most important information I should know about acetaminophen and hydrocodone? Keep the medication in a place where others cannot get to it. An overdose of acetaminophen can damage your liver or cause death. Call your doctor at once if you have pain in your upper stomach, loss of appetite, dark urine, or jaundice yellowing of your skin or eyes. Taking opioid medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn. Fatal side effects can occur if you use opioid medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.

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If you are a consumer or patient please visit this version. 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. 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 adose increase [see WARNINGS ]. Accidental ingestion of even one dose of hydrocodone bitartrate and acetaminophen tablets, especially by children, can result in a fatal overdose of Hydrocodone bitartrate and acetaminophen tablets[see WARNINGS ]. 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 andtreated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in apregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see WARNINGS ]. Acetaminophenhas been associated with cases of acute liver failure, at times resulting inliver transplant and death. Most of the cases of liver injury are associatedwith the use of acetaminophen at doses that exceed 4, milligrams per day,and often involve more than one acetaminophen-containing product see WARNINGS. Concomitant use of opiods with benzodiazepines or other central nervous system CNS depressants including alcohol, may result in profound sedation, respiratory depression, coma, and death. Hydrocodone bitartrate and acetaminophen is supplied in tablet form for oral administration.

Other opioids may be tried as some cases reported use of a different opioid without recurrence of adrenal insufficiency.

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. Each tablet contains 5 mg hydrocodone bitartrate and mg acetaminophen. Each tablet contains 7. Each tablet contains 10 mg hydrocodone bitartrate and mg acetaminophen. Dispense in a tight, light-resis tan t container as defined in the USP with a child-resis tan t closure.

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. Each tablet contains 5 mg hydrocodone bitartrate and mg acetaminophen. Each tablet contains 7. Each tablet contains 10 mg hydrocodone bitartrate and mg acetaminophen. Dispense in a tight, light-resis tan t container as defined in the USP with a child-resis tan t closure. Keep this and all medication out of the reach of children. A Schedule C-II controlled drug subs tan ce.

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If you are a consumer or patient please visit this version. 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.

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Educate patients and caregivers on how to recognize respiratory depression and emphasize the importance of calling or getting emergency medical help right away in the event of a known or suspected overdose [see WARNINGS, Life Threatening Respiratory Depression ]. Like all full opioid agonists, there is no ceiling effect for analgesia with hydrocodone. Food and Drug Administration. Renal tubular necrosis, hypoglycemic coma and coagulation defects may also occur. In acetaminophen overdosage: dose-dependent, potentially fatal hepatic necrosis isthe most serious adverse effect. The administration of Hydrocodone Bitartrate and Acetaminophen Tablets or other opioids may obscure the diagnosis or clinical course in patients with acute abdominal conditions. Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea. Infants exposed to hydrocodone bitartrate and acetaminophen through breast milkshould be monitored for excess sedation and respiratory depression. Taking certain medications together can lead to a fatal overdose. There are no standard opioid tapering schedules that are suitable for all patients. 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. An overdose can damage your liver or cause death. Selling or giving away hydrocodone bitartrate and acetaminophen tablets is against the law. Neonatal Opioid Withdrawal Syndrome Prolonged useof hydrocodone bitartrate and acetaminophen tablets during pregnancy can resultin withdrawal in the neonate. Infertility Chronic use of opioids may cause reduced fertility in females and males of reproductive potential.

If you are a consumer or patient please visit this version.

Marketing Information. In contrast, there was no evidence of carcinogenic activity in male rats that received up to 0. Oxygen, intravenous fluids, vasopressors, and other supportive measures should beemployed as indicated. Medicinesare sometimes prescribed for purposes other than those listed in a MedicationGuide. For clinically significantrespiratory or circulatory depression secondary to hydrocodone bitartrate andacetaminophen tablets overdose, administer an opioid antagonist. 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 ]. There were infrequent reports of life-threatening anaphylaxis requiring emergency medical attention. Concomitant use of Hydrocodone Bitartrate and Acetaminophen Tablets with CYP3A4 inducers or discontinuation of an CYP3A4 inhibitor could decrease hydrocodone plasma concentrations, decrease opioid efficacy or, possibly, lead to a withdrawal syndrome in a patient who had developed physical dependence to hydrocodone. Adrenal Insufficiency Cases of adrenal insufficiency have beenreported with opioid use, more often following greater than 1 month of use. Continually reevaluate patients receiving hydrocodonebitartrate and acetaminophen tablets to assess the maintenance of pain controland the relative incidence of adverse reactions, as well as monitoring for thedevelopment of addiction, abuse, or misuse [see WARNINGS ]. Keep this and all medication out of the reach of children. Cough Reflex Hydrocodone suppresses the cough reflex;as with all narcotics, caution should be exercised when hydrocodone bitartrateand acetaminophen tablets are used postoperatively and in patients with pulmonarydisease. Lactation Advise nursing mothers to monitor infants for increased sleepiness more than usual , breathing difficulties, or limpness. Instruct patients not to share hydrocodone bitartrate and acetaminophen tablets with others and to take steps to protect hydrocodone bitartrate and acetaminophen tablets from theft ormisuse. Informpatients that the use of hydrocodone bitartrate and acetaminophen tablets, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death [see WARNINGS ].