hydrocodone bitartrate and acetaminophen tablet

INDICATIONS AND USAGE Hydrocodone Bitartrate and Acetaminophen Tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse, with opioids, which can occur at any dosage or duration [see WARNINGS ], reserve Hydrocodone Bitartrate and Acetaminophen Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): have not been tolerated or are not expected to be tolerated, have not provided adequate analgesia or are not expected to provide adequate analgesia Hydrocodone Bitartrate and Acetaminophen Tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.

amneal pharmaceuticals of new york llc

FDA Reported Adverse Reactions
`[1] drug dependence` `[2] pain` `[3] overdose` `[4] drug ineffective` `[5] emotional distress` `[6] off label use` `[7] fatigue` `[8] nausea` `[9] diarrhoea` `[10] anxiety`

1 year ago

OVAL WHITE IP 109

1 year ago

IP 109 OVAL WHITE

HOW SUPPLIED

HYDROCODONE BITARTRATE AND ACETAMINOPHEN Tablets, USP, 5 mg/325 mg , are supplied as white to off-white, scored, oblong biconvex tablets, debossed “IP 109” on obverse and bisected on the reverse. Each tablet contains 5 mg hydrocodone bitartrate, USP and 325 mg acetaminophen, USP. They are available as follows: Bottles of 100: NDC 53746-109-01 Bottles of 500: NDC 53746-109-05 Bottles of 1,000: NDC 53746-109-10 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. A Schedule II Narcotic DEA Order Form Required. Store

HYDROCODONE BITARTRATE AND ACETAMINOPHEN Tablets securely and dispose of properly [see PRECAUTIONS ; Information for Patients ]. Manufactured by: Amneal Pharmaceuticals of NY, LLC Brookhaven, NY 11719 Rev. 01-2024-14

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