morphine sulfate 15 mg
1 INDICATIONS AND USAGE Morphine Sulfate Tablets are indicated for the management of: adults with acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. adults with chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Morphine Sulfate Tablets are an opioid agonist indicated for the management of: adults with acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. ( 1 ) adults with chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. ( 1 ) Limitations of Use ( 1 ) Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve Morphine Sulfate Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: Have not been tolerated, or are not expected to be tolerated, Have not provided adequate analgesia, or are not expected to provide adequate analgesia. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1) ] , reserve Morphine Sulfate Tablets for use in patients for whom alternative treatment options [e.g., non- opioid analgesics or opioid combination products]: Have not been tolerated, or are not expected to be tolerated, Have not provided adequate analgesia, or are not expected to provide adequate analgesia. Pediatric use information is approved for Hikma Pharmaceuticals USA Inc.'s morphine sulfate tablets. However, due to Hikma Pharmaceuticals USA Inc.'s marketing exclusivity rights, this drug product is not labeled with that information.
mayne pharma inc
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16 HOW SUPPLIED/STORAGE AND HANDLING
MORPHINE SULFATE Tablets 15 mg: Each tablet contains 15 mg
MORPHINE SULFATE, USP (equivalent to 11.25 mg morphine) and is a round white to off-white, flat faced beveled edge tablet debossed with "615" on one side and scored on the other. NDC 51862-615-01: Bottle of 100 Tablets 30 mg: Each tablet contains 30 mg
MORPHINE SULFATE, USP (equivalent to 22.5 mg morphine) and is a round white to off-white, flat faced beveled edge tablet debossed with "630" on one side and scored on the other. NDC 51862-617-01: Bottle of 100 Tablets Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. Store
MORPHINE SULFATE Tablets securely and dispose of properly [see Patient Counseling Information (17) ].
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