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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.

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.

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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. If you think you may have a medical emergency, please dial While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Pill Sync.

Hydrocodone bitartrate and acetaminophen tablets USP, for oral administration, are available in a variety of strengths as described in the following table. Be white oval tablet u03 your doctor knows if you also use:. Adjust the dosage to obtain an appropriatebalance between management of pain and opioid-related adverse reactions.

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.

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. 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.

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Hydrocodone bitartrate and acetaminophen tablet contains hydrocodone and acetaminophen a Schedule CII controlled substance. NDC National Drug Code - Each drug product is assigned this unique number which can be found on the drug's outer packaging. The clinical significance of these findings is unknown. Because theduration of opioid reversal is expected to be less than the duration of actionof hydrocodone bitartrate and acetaminophen tablets in hydrocodone bitartrateand acetaminophen tablets, carefully monitor the patient until spontaneousrespiration is reliably re-established. Consider these risks when prescribing or dispensing hydrocodone bitartrate and acetaminophen tablets. Always check your bottle to make sure you have received the correct pills same brand and type of medicine prescribed by your doctor. The clinical significance of these findings is not known. Vigoroussupportive therapy is required in severe intoxication. What is the most important information I should know about acetaminophen and hydrocodone? Addiction can occur at recommended dosages and if the drug is misused orabused. Clinical Presentation. Clinicalstudies of hydrocodone bitartrate 5 mg and acetaminophen mg did not includesufficient numbers of subjects aged 65 and over to determine whether theyrespond differently from younger subjects. Serotonin syndrome: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs. If adrenal insufficiency is suspected, confirm the diagnosis with diagnostic testing as soon as possible. Titration and Maintenance of Therapy Individually titrate hydrocodone bitartrate and acetaminophen tablets to a dose that provides adequate analgesia and minimizes adverse reactions.

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

The severity of the withdrawal symptoms experienced will depend on the degree of physical dependence and the dose of the antagonist administered. Follow all directions on your prescription label. Overestimating the hydrocodone bitartrate and acetaminophen tablets dosage when converting patients from another opioid product can result in a fatal overdose with the first dose. The presence of risk factors for overdose should not prevent the proper management of pain in any given patient. Labor and Delivery Aswith all narcotics, administration of this product to the mother shortly beforedelivery may result in some degree of respiratory depression in the newborn,especially if higher doses are used. Product Characteristics. Serumacetaminophen levels should be obtained immediately if the patient presents 4hours or more after ingestion to assess potential risk of hepatotoxicity;acetaminophen levels drawn less than 4 hours post-ingestion may be misleading. Save my name, email, and website in this browser for the next time I comment. Nursing Mothers Hydrocodone is present in human milk. 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. This could occur even if you have taken acetaminophen in the past and had no reaction. Controlled Substance Hydrocodone bitartrate and acetaminophen tablets contains hydrocodone and acetaminophen, a Schedule CII controlled substance. 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. NDC 1 2 3 4 5 6 7 8 9 10 11 12