morphine sulfate Morphine Sulfate 30 MG Extended Release Oral Tablet
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 )
Qualitest Pharmaceuticals
ROUND GREEN E653 30
E653 30 ROUND GREEN
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16 HOW SUPPLIED/STORAGE AND HANDLING Morphine sulfate extended-release tablets 15 mg are blue, round tablets, debossed “E652” on one side, and “15” on the other side. They are supplied as follows: NDC 60951-652-70: bottles containing 100 tablets Morphine sulfate extended-release tablets 30 mg are green, round tablets, debossed “E653” on one side, and “30” on the other side. They are supplied as follows: NDC 60951-653-70: bottles containing 100 tablets Morphine sulfate extended-release tablets 60 mg are orange, capsule-shaped tablets, debossed “E655” on one side, and “60” on the other side. They are supplied as follows: NDC 60951-655-70: bottles containing 100 tablets Morphine sulfate extended-release tablets 100 mg are blue, capsule-shaped tablets, debossed “E658” on one side, and “100” on the other side. They are supplied as follows: NDC 60951-658-70: bottles containing 100 tablets Morphine sulfate extended-release tablets 200 mg are green, oval tablets, debossed “E659” on one side and “200” on the other side. They are supplied as follows: NDC 60951-659-70: bottles containing 100 tablets Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F). Dispense in a tight, light-resistant container. CAUTION DEA FORM REQUIRED
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