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. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [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. Morphine sulfate tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate. 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. 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. adults with chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use ( 1 ) Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration ( 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. Morphine sulfate tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.
specgx llc
ROUND WHITE M 1 5
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morphine sulfate 30 mg
specgx llc
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16 HOW SUPPLIED/STORAGE AND HANDLING
MORPHINE SULFATE Tablets are supplied as follows: Each 15 mg tablet for oral administration contains: 15 mg
MORPHINE SULFATE USP and is a white, biconvex tablet, debossed “M†on one side, and “15†with a score on the other side. 15 mg bottles of 100: NDC 0406-5118-01 15 mg box of 100 unit dose: NDC 0406-5118-62 Each 30 mg tablet for oral administration contains: 30 mg
MORPHINE SULFATE USP and is a white, biconvex tablet, debossed “M†on one side, and “30†with a score on the other side. 30 mg bottles of 100: NDC 0406-5119-01 30 mg box of 100 unit dose: NDC 0406-5119-62 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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