Morphine Sulfate 30 MG Extended Release Oral Tablet
1 INDICATIONS AND USAGE Morphine sulfate extended-release tablets are an opioid agonist product 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 ) 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.
zydus pharmaceuticals (usa) inc.
OVAL PINK N 30
N 30 OVAL PINK
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16 HOW SUPPLIED/STORAGE AND HANDLING Morphine Sulfate Extended-Release Tablets 15 mg are oval, film-coated, green tablets debossed "N" on one side and "15" on the other. They are supplied as follows: NDC 68382-903-01…………Bottles of 100 tablets Morphine Sulfate Extended-Release Tablets 30 mg are oval, film-coated, pink tablets, debossed "N" on one side and "30" on the other. They are supplied as follows: NDC 68382-904-01…………Bottles of 100 tablets Morphine Sulfate Extended-Release Tablets 60 mg are oval, film-coated, white tablets debossed "N" on one side and "60" on the other. They are supplied as follows: NDC 68382-905-01…………Bottles of 100 tablets Morphine Sulfate Extended-Release Tablets 100 mg are oval, film-coated, gray tablets debossed "N" on one side and "100" on the other. They are supplied as follows: NDC 68382-906-01…………Bottles of 100 tablets Morphine Sulfate Extended-Release Tablets 200 mg are oval, film-coated, brown tablets debossed "N" on one side and "200" on the other. They are supplied as follows: NDC 68382-907-01…………Bottles of 100 tablets Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) [see USP Controlled Room Temperature.] Dispense in a tight, light-resistant and child-resistant container. CAUTION DEA FORM REQUIRED
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