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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.

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. 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. 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 potential for these risks should not, white oval tablet u03, however, prevent the proper management of pain in any given patient. It is important to ensure ongoing care of the patient and to agree on an appropriate tapering schedule and follow-up plan so that patient and provider goals and expectations are clear and realistic.

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.

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. While we do our best to index pills, there could still be small errors. This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice.

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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 ].

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Do not abruptly discontinue hydrocodone bitartrate and acetaminophen tablets in patients who may be physically dependent on opioids. Inpairment of Fertility In studies conducted by the National Toxicology Program, fertility assessments with acetaminophen have been completed in Swiss CD-1 mice via a continuous breeding study. Adrenal Insufficiency Cases of adrenal insufficiency have beenreported with opioid use, more often following greater than 1 month of use. Do not abruptly discontinue Hydrocodone Bitartrate and Acetaminophen Tablets in a patient physically dependent on opioids. Early symptoms following a potentially hepatotoxic overdose may include: nausea,vomiting, diaphoresis and general malaise. If you miss a dose, take your next dose at your usual time. When apatient who has been taking hydrocodone bitartrate and acetaminophen tabletsregularly and may be physically dependent no longer requires therapy with hydrocodonebitartrate and acetaminophen tablets, use a gradual downward titration of thedosage to prevent signs and symptoms of withdrawal. 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 or misuse. These effects appear to increase with the duration of treatment. Serotonin Syndrome Inform patients that hydrocodone bitartrate and acetaminophen tablets could cause a rare but potentially life-threatening condition resulting from concomitant administration of serotonergic drugs. Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised.

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.

Hydrocodone bitartrate and acetaminophen tablets contains hydrocodone and acetaminophen, asubstance with a high potential for abuse similar to other opioids including withdrawal also may be precipitated through the administration of drugs withopioid antagonist activity e. 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. Hydrocodone bitartrate and acetaminophen is supplied in tablet form for oral administration. Do not abruptly discontinue hydrocodone bitartrate and acetaminophen tablets in patients who may be physically dependent on opioids. Hydrocodone and acetaminophen are known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. A Schedule C-II controlled drug substance. Physical dependence may not occur to a clinically significant degree until after several days to weeks of continued opioid usage. Call your doctor for medical advice about side effects. Bothtolerance and physical dependence can develop during chronic opioid therapy. General Information about Hydrocodone Bitartrate and Acetaminophen Tablets Medicinesare sometimes prescribed for purposes other than those listed in a MedicationGuide. If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Properassessment of the patient, proper prescribing practices, periodic re-evaluationof therapy, and proper dispensing and storage are appropriate measures thathelp to limit abuse of opioid drugs. Gastrointestinal System constipation.