Morphine Sulfate 80 MG Extended Release Oral Capsule
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. 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/long-acting 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. 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. ( 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 )
Amneal Pharmaceuticals of New York LLC
CAPSULE ORANGE J66
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16 HOW SUPPLIED/STORAGE AND HANDLING
MORPHINE SULFATE extended-release capsules, USP contain white to off-white polymer-coated extended-release pellets of
MORPHINE SULFATE and are available in seven dose strengths.
MORPHINE SULFATE Extended-Release capsules USP, 20 mg are size 4 capsule, yellow opaque body and cap, imprinted with “J62” in black ink on cap. capsules are supplied as follows: Bottles of 30: NDC 0115-1277-08 Bottles of 60: NDC 0115-1277-13 Bottles of 100: NDC 0115-1277-01 Bottles of 1000: NDC 0115-1277-03
MORPHINE SULFATE Extended-Release capsules USP, 30 mg are size 4 capsule, violet opaque body and cap, imprinted with “J63” in black ink on cap. capsules are supplied as follows: Bottles of 30: NDC 0115-1278-08 Bottles of 60: NDC 0115-1278-13 Bottles of 100: NDC 0115-1278-01 Bottles of 1000: NDC 0115-1278-03
MORPHINE SULFATE Extended-Release capsules USP, 40 mg are size 2 capsule, blue violet opaque body and rich yellow opaque cap, imprinted with “J69” in black ink on cap. capsules are supplied as follows: Bottles of 100: NDC 0115-1479-01
MORPHINE SULFATE Extended-Release capsules USP, 50 mg are size 2 capsule, light blue opaque body and cap, imprinted with “J64” in black ink on cap. capsules are supplied as follows: Bottles of 30: NDC 0115-1279-08 Bottles of 60: NDC 0115-1279-13 Bottles of 100: NDC 0115-1279-01 Bottles of 1000: NDC 0115-1279-03
MORPHINE SULFATE Extended-Release capsules USP, 60 mg are size 1 capsule, red opaque body and cap, imprinted with “J65” in black ink on cap. capsules are supplied as follows: Bottles of 30: NDC 0115-1280-08 Bottles of 60: NDC 0115-1280-13 Bottles of 100: NDC 0115-1280-01 Bottles of 1000: NDC 0115-1280-03
MORPHINE SULFATE Extended-Release capsules USP, 80 mg are size 0 capsule, orange opaque body and cap, imprinted with “J66” in black ink on cap. capsules are supplied as follows: Bottles of 30: NDC 0115-1281-08 Bottles of 60: NDC 0115-1281-13 Bottles of 100: NDC 0115-1281-01 Bottles of 1000: NDC 0115-1281-03
MORPHINE SULFATE Extended-Release capsules USP, 100 mg are size 0 capsule, light green opaque body and cap, imprinted with “J67” in black ink on cap. capsules are supplied as follows: Bottles of 30: NDC 0115-1282-08 Bottles of 60: NDC 0115-1282-13 Bottles of 100: NDC 0115-1282-01 Bottles of 1000: NDC 0115-1282-03 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tightly-closed, light-resistant container as defined in the USP, with a child-resistant closure, as required. Store
MORPHINE SULFATE extended-release capsules securely and dispose of properly [see Patient Counseling Information (17) ] .
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