morphine sulfate 100 mg
1 INDICATIONS AND USAGE Morphine sulfate extended-release capsules are indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. Morphine sulfate extended-release capsules is indicated for the management of severe and persistent pain that requires an extended period with a daily opioid analgesic and for which alternative treatment options are inadequate. ( 1 ) Limitations of Use: Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations, reserve morphine sulfate extended-release capsules 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 capsules are not indicated as an as-needed (prn) analgesic. ( 1 ) Limitations of Use: Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, 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 capsules 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 capsules are not indicated as an as-needed (prn) analgesic.
upsher-smith laboratories, llc
CAPSULE GREEN UPSHER SMITH 0233 100 mg
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16 HOW SUPPLIED/STORAGE AND HANDLING
MORPHINE SULFATE extended-release capsules, USP contain white to off-white or tan colored polymer coated pellets of
MORPHINE SULFATE and are available in seven dose strengths: 10 mg, size 4, light blue, opaque capsule printed with "UPSHER-SMITH" over "0225" and "10 mg" in black ink. They are supplied as follows: Bottles of 100 with child-resistant closure, NDC 0832-0225-00 Bottles of 500, NDC 0832-0225-50 20 mg, size 4, yellow, opaque capsule printed with "UPSHER-SMITH" over "0226" and "20 mg" in black ink. They are supplied as follows: Bottles of 100 with child-resistant closure, NDC 0832-0226-00 Bottles of 500, NDC 0832-0226-50 30 mg, size 2, blue violet, opaque capsule printed with "UPSHER-SMITH" over "0227" and "30 mg" in black ink. They are supplied as follows: Bottles of 100 with child-resistant closure, NDC 0832-0227-00 Bottles of 500, NDC 0832-0227-50 50 mg, size 2, blue, opaque capsule printed with "UPSHER-SMITH" over "0228" and "50 mg" in black ink. They are supplied as follows: Bottles of 100 with child-resistant closure, NDC 0832-0228-00 Bottles of 500, NDC 0832-0228-50 60 mg, size 1, pink, opaque capsule printed with "UPSHER-SMITH" over "0229" and "60 mg" in black ink. They are supplied as follows: Bottles of 100 with child-resistant closure, NDC 0832-0229-00 Bottles of 500, NDC 0832-0229-50 80 mg, size 1, light orange, opaque capsule printed with "UPSHER-SMITH" over "0230" and "80 mg" in black ink. They are supplied as follows: Bottles of 100 with child-resistant closure, NDC 0832-0230-00 Bottles of 500, NDC 0832-0230-50 100 mg, size 0, green, opaque capsule printed with "UPSHER-SMITH" over "0233" and "100 mg" in black ink. They are supplied as follows: Bottles of 100 with child-resistant closure, NDC 0832-0233-00 Bottles of 500, NDC 0832-0233-50 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a sealed, tamper-evident, child-resistant, light-resistant container. Store
MORPHINE SULFATE extended-release capsules securely and dispose of properly [see Patient Counseling Information (17) ] .
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