hydrocodone bitartrate and acetaminophen tablet

INDICATIONS AND USAGE Hydrocodone bitartrate and acetaminophen tablets are indicated for the management of moderate to moderately severe 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, even at recommended doses [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

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FDA Reported Adverse Reactions
`[1] off label use` `[2] fatigue` `[3] drug ineffective` `[4] pain` `[5] nausea` `[6] headache` `[7] arthralgia` `[8] pyrexia` `[9] dyspnoea` `[10] toxicity to various agents`

6 years ago

OVAL WHITE Watson 853

6 years ago

Watson 853 OVAL WHITE

HOW SUPPLIED Product: 63629-7424

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