To view updated drug label links, paste the RSS feed address (URL) shown below into a RSS reader, or use a browser which supports RSS feeds, such as Safari for Mac OS X.If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader. Renal tubular necrosis, hypoglycemic coma and coagulation defects may also occur.Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis and general malaise. The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. Due to inconsistencies between the drug labels on DailyMed and the pill images provided by The severity of the withdrawal symptoms experienced will depend on the degree of physical dependence and the dose of the antagonist administered. Copy the URL below and paste it into your RSS Reader application.DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed.DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. 46672-147-10, Advise patients to seek medical attention if they experience a constellation of these symptoms [see Discuss with the patient and caregiver the availability of naloxone for the emergency treatment of opioid overdose, both when initiating and renewing treatment with hydrocodone bitartrate and acetaminophen tablets. Tablets are debossed with “A” score “P” on one side and “0075” on the other side, and are supplied in bottles of 100 tablets, NDC 46672-147-10, and 500 tablets, NDC 46672-147-50.Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure.Store hydrocodone bitartarte and acetaminophen tablets securely and dispose of properly [see Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). Clinically, dosage is titrated to provide adequate analgesia and may be limited by adverse reactions, including respiratory and CNS depression.The precise mechanism of the analgesic action is unknown. Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised.Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.Hydrocodone bitartrate and acetaminophen tablets are for oral use only. Follow patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy and following dosage increases with hydrocodone bitartrate and acetaminophen tablets and adjust the dosage accordingly [see
To use the sharing features on this page, please enable JavaScript. FDA held discussions about naloxone availability with the Anesthetic and Analgesic Drug Products and the Drug Safety and Risk Management Advisory Committees, available at: Benzhydrocodone and acetaminophen may be habit forming, especially with prolonged use. While taking benzhydrocodone and acetaminophen, discuss with your health care provider your pain treatment goals, length of treatment, and other ways to manage your pain. The plasma half-life is 1.25 to 3 hours, but may be increased by liver damage and following overdosage.
Tell your doctor if you have or have ever had slowed breathing or asthma. Adrenal insufficiency may present with non-specific symptoms and signs such as nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4,000 milligrams per day, and often involve more than one acetaminophen-containing product [see
However, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play a role in the analgesic effects of this drug.The precise mechanism of the analgesic properties of acetaminophen is not established but is thought to involve central actions.The principal therapeutic action of hydrocodone is analgesia.
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