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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

4 years ago OVAL YELLOW 29 Oxycodone hydrochloride and Ibuprofen Oral Tablet


HOW SUPPLIED Oxycodone Hydrochloride and Ibuprofen Tablets, 5 mg/400 mg are available as follows: Each yellow, capsule-shaped, film-coated tablet imprinted with 29 on one side and bisect on both sides contains 5 mg of Oxycodone hydrochloride, USP and 400 mg of Ibuprofen, USP. Tablets are supplied in bottles of 30 (NDC 0228-4029-03) and 100 (NDC 0228-4029-11) and 500 (NDC 0228-4029-50). Dispense in a tight, light-resistant container as defined in the USP. Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature]. Store Oxycodone Hydrochloride and Ibuprofen Tablets securely and dispose of properly [see PRECAUTIONS ; Information for Patients ] . Manufactured by: Actavis Elizabeth LLC Elizabeth, NJ 07207 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Rev. F 8/2020 2491fc3e-figure-03

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