morphine sulfate tablet film coated 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)
sun pharmaceutical industries, inc.
ROUND BLUE RD 70
RD 70 ROUND BLUE
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morphine sulfate 30 mg
sun pharmaceutical industries, inc.
morphine sulfate tablet film coated extended release
sun pharmaceutical industries, inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING
MORPHINE SULFATE extended-release tablets are supplied as follows:
MORPHINE SULFATE extended-release tablets 15 mg are round, blue-colored, film-coated tablets debossed with “RD†and “70†on one side and plain on the other side. They are supplied as follows: NDC 63304-450-03 Bottles of 10 NDC 63304-450-01 Bottles of 100 NDC 63304-450-05 Bottles of 500
MORPHINE SULFATE extended-release tablets 30 mg are round, purple-colored, film-coated tablets debossed with “RD†and “71†on one side and plain on the other side. They are supplied as follows: NDC 63304-451-03 Bottles of 10 NDC 63304-451-01 Bottles of 100 NDC 63304-451-05 Bottles of 500
MORPHINE SULFATE extended-release tablets 60 mg are round, light orange-colored, film-coated tablets debossed with “RD†and “72†on one side and plain on the other side. They are supplied as follows: NDC 63304-758-03 Bottles of 10 NDC 63304-758-50 Bottles of 50 NDC 63304-758-01 Bottles of 100 NDC 63304-758-05 Bottles of 500
MORPHINE SULFATE extended-release tablets 100 mg are round, gray-colored, film-coated tablets debossed with “RD†and “73†on one side and plain on the other side. They are supplied as follows: NDC 63304-452-03 Bottles of 10 NDC 63304-452-01 Bottles of 100 NDC 63304-452-05 Bottles of 500
MORPHINE SULFATE extended-release tablets 200 mg are oval, green-colored, film-coated tablets debossed with “RD74†on one side and plain on the other side. They are supplied as follows: NDC 63304-453-03 Bottles of 10 NDC 63304-453-01 Bottles of 100 NDC 63304-453-05 Bottles of 500 Store at 20° - 25° C (68° - 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.
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