Acetaminophen 300 MG Hydrocodone Bitartrate 10 MG Oral 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, 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

Par Pharmaceutical

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

5 years ago

OVAL WHITE BP 643 10

HOW SUPPLIED Hydrocodone Bitartrate and Acetaminophen Tablets, USP are supplied as follows: Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/300 mg are supplied as white to off-white, capsule shaped tablets containing 5 mg hydrocodone bitartrate ( WARNING: May be habit-forming ) and 300 mg acetaminophen. Tablets are debossed "BP" bisect "648" on one side and "5" on the other side, and are supplied in bottles of 100 tablets, NDC 64376-648-01 and 500 tablets, NDC 64376-648-05. Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/300 mg are supplied as white to off-white, capsule shaped tablets containing 7.5 mg hydrocodone bitartrate ( WARNING: May be habit-forming ) and 300 mg acetaminophen. Tablets are debossed "BP" bisect "649" on one side and "7.5" on the other side, and are supplied in bottles of 100 tablets, NDC 64376-649-01 and 500 tablets, NDC 64376-649-05. Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/300 mg are supplied as white to off-white, capsule shaped tablets containing 10 mg hydrocodone bitartrate ( WARNING: May be habit-forming ) and 300 mg acetaminophen. Tablets are debossed "BP" bisect "643" on one side and "10" on the other side, and are supplied in bottles of 100 tablets, NDC 64376-643-01 and 500 tablets, NDC 64376-643-05. 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 bitartrate and acetaminophen tablets securely and dispose of properly [see PRECAUTIONS; Information for Patients ].

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