Oxycodone hydrochloride and Ibuprofen Oral Tablet

INDICATIONS AND USAGE Oxycodone Hydrochloride and Ibuprofen Tablets are indicated for the management of short term (no more than 7 days) acute to moderate 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 Oxycodone Hydrochloride and Ibuprofen Tablets and other treatment options before deciding to use Oxycodone Hydrochloride and Ibuprofen Tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see WARNINGS; Cardiovascular Thrombotic Events, and Gastrointestinal Bleeding, Ulceration, and Perforation ]. Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS; Addiction, Abuse, and Misuse ], reserve Oxycodone Hydrochloride 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

Actavis Elizabeth LLC

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