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morphine sulfate tablet extended release

1 INDICATIONS AND USAGE Morphine sulfate extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations [see Warnings and Precautions (5.1) ] , reserve morphine sulfate extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Morphine sulfate extended-release tablets are not indicated as an as-needed (prn) analgesic. Morphine sulfate extended-release tablets are an opioid agonist indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. ( 1 ) Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve morphine sulfate extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. ( 1 ) Morphine sulfate extended-release tablets are not indicated as an as-needed (prn) analgesic. ( 1 )

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5 years ago ROUND PURPLE M 30 morphine sulfate tablet extended release

ROUND PURPLE M 30

5 years ago ROUND PURPLE M 30 morphine sulfate tablet extended release

M 30 ROUND PURPLE

16 HOW SUPPLIED/STORAGE AND HANDLING Each

MORPHINE SULFATE Extended-Release Tablet 15 mg is available as a round, blue convex tablet, one side debossed and the other side debossed “15”. Bottles of 100 ................................. NDC 0406-8315-01 Unit Dose (10 x 10)......................... NDC 0406-8315-62 Each

MORPHINE SULFATE Extended-Release Tablet 30 mg is available as a round, purple convex tablet, one side debossed and the other side debossed “30”. Bottles of 100 ................................. NDC 0406-8330-01 Unit Dose (10 x 10)......................... NDC 0406-8330-62 Each

MORPHINE SULFATE Extended-Release Tablet 60 mg is available as a round, orange convex tablet, one side debossed and the other side debossed “60”. Bottles of 100 ................................. NDC 0406-8380-01 Unit Dose (10 x 10)......................... NDC 0406-8380-62 Each

MORPHINE SULFATE Extended-Release Tablet 100 mg is available as a round, gray convex tablet, one side debossed and the other side debossed “100”. Bottles of 100 ................................. NDC 0406-8390-01 Unit Dose (10 x 10)......................... NDC 0406-8390-62 Each

MORPHINE SULFATE Extended-Release Tablet 200 mg is available as a capsule-shaped, green convex tablet, one side debossed and the other side debossed “200”. Bottles of 100 ................................. NDC 0406-8320-01 Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Store

MORPHINE SULFATE extended-release tablets securely and dispose of properly [see Patient Counseling Information (17) ] . Dispense in a tight, light-resistant container. Boxed M Boxed M Boxed M Boxed M Boxed M


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