Hydrocodone Bitartrate 7.5 MG Ibuprofen 200 MG Oral Tablet

INDICATIONS AND USAGE Hydrocodone bitartrate and ibuprofen tablets are indicated for the short-term management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Carefully consider the potential benefits and risks of hydrocodone bitartrate and ibuprofen tablets and other treatment options before deciding to use hydrocodone bitartrate and ibuprofen tablets. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Cardiovascular Thrombotic Events , Gastrointestinal Bleeding, Ulceration, and Perforation ). Do not use hydrocodone bitartrate and ibuprofen tablets for the treatment of conditions such as osteoarthritis or rheumatoid arthritis. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses (see WARNINGS: Addiction, Abuse, and Misuse ), reserve hydrocodone bitartrate and ibuprofen 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

American Health Packaging

FDA Reported Adverse Reactions
`[1] off label use` `[2] febrile neutropenia` `[3] drug ineffective` `[4] neutropenia` `[5] pyrexia` `[6] nausea` `[7] disease progression` `[8] product use in unapproved indication` `[9] pneumonia` `[10] thrombocytopenia`

4 years ago

ROUND WHITE IP 145

4 years ago

IP 145 ROUND WHITE

HOW SUPPLIED

HYDROCODONE BITARTRATE AND IBUPROFEN tablets, 7.5 mg/200 mg , are supplied as white, round, film-coated, biconvex tablets, debossed with “IP” over “145” on one side and plain on the other side. They are available as follows: Unit dose packages of 100 (10 x 10) NDC 68084-841-01 Storage Store at room temperature 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken. Store

HYDROCODONE BITARTRATE AND IBUPROFEN tablets securely and dispose of properly (see PRECAUTIONS: Information for Patients ). DEA Order Form Required. Dispense with Medication Guide To order more Medication Guides call American Health Packaging at 1‐800‐707‐4621.

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Hydrocodone Bitartrate 7.5 MG Ibuprofen 200 MG Oral Tablet

FDA Reported Adverse Reactions [1] off label use [2] febrile neutropenia [3] drug ineffective [4] neutropenia [5] pyrexia [6] nausea [7] disease progression [8] product use in unapproved indication [9] pneumonia [10] thrombocytopenia

ROUND WHITE IP 145

IP 145 ROUND WHITE

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FDA Reported Adverse Reactions
`[1] off label use` `[2] febrile neutropenia` `[3] drug ineffective` `[4] neutropenia` `[5] pyrexia` `[6] nausea` `[7] disease progression` `[8] product use in unapproved indication` `[9] pneumonia` `[10] thrombocytopenia`