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Author: Admin | 2025-04-28
To properly measure and take hydrocodone bitartrate and acetaminophen oral solution [see DOSAGE AND ADMINISTRATION, WARNINGS]. Advise patients to always use the enclosed calibrated oral syringe/dosing cup when administering hydrocodone bitartrate and acetaminophen oral solution to ensure the dose is measured and administered accurately [see WARNINGS]. Advise patients never to use household teaspoons or tablespoons to measure hydrocodone bitartrate and acetaminophen oral solution. Advise patients not to adjust the dose of hydrocodone bitartrate and acetaminophen oral solution without consulting with a physician or other healthcare professional. If patients have been receiving treatment with hydrocodone bitartrate and acetaminophen oral solution for more than a few weeks and cessation of therapy is indicated, counsel them on the importance of safely tapering the dose as abrupt discontinuation of the medication could precipitate withdrawal symptoms. Provide a dose schedule to accomplish a gradual discontinuation of the medication [see DOSAGE AND ADMINISTRATION]. Important Discontinuation Instructions In order to avoid developing withdrawal symptoms, instruct patients not to discontinue hydrocodone bitartrate and acetaminophen oral solution without first discussing a tapering plan with the prescriber [see DOSAGE AND ADMINISTRATION]. Maximum Daily Dose of Acetaminophen Inform patients to not take more than 4000 milligrams of acetaminophen per day. Advise patients to call their prescriber if they take more than the recommended dose. Hypotension Inform patients that hydrocodone bitartrate and acetaminophen oral solution may cause orthostatic hypotension and syncope. Instruct patients how to recognize symptoms of low blood pressure and how to reduce the risk of serious consequences should hypotension occur (e.g., sit or lie down, carefully rise from a sitting or lying position) [see WARNINGS]. Anaphylaxis Inform patients that anaphylaxis has been reported with ingredients contained in hydrocodone bitartrate and acetaminophen oral solution. Advise patients how to recognize such a reaction and when to seek medical attention [see CONTRAINDICATIONS, ADVERSE REACTIONS]. Pregnancy Neonatal Opioid Withdrawal Syndrome Inform female patients of reproductive potential that prolonged use of hydrocodone bitartrate and acetaminophen oral solution during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated [see WARNINGS, PRECAUTIONS; Pregnancy]. Embryo-Fetal Toxicity Inform female patients of reproductive potential that hydrocodone bitartrate and acetaminophen oral solution can cause fetal harm and to inform their healthcare provider of a known or suspected pregnancy [see PRECAUTIONS; Pregnancy]. Lactation Advise nursing mothers to monitor infants for increased sleepiness (more than usual), breathing difficulties, or limpness. Instruct nursing mothers to
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