24 HR Morphine Sulfate 120 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/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 an opioid agonist 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 )
actavis pharma, inc.
CAPSULE BLUE logo 3093
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16 HOW SUPPLIED/STORAGE AND HANDLING
MORPHINE SULFATE Extended-Release capsules, USP (Once Daily) are available as follows: 30 mg – Size 3 capsule with dark blue opaque cap and body, printed with and 3090 on both the cap and body in black ink. capsules are supplied in bottles of 100 (NDC 0228-3090-11). 45 mg – Size 3 capsule with violet opaque cap and body, printed with and 3116 on both the cap and body in black ink. capsules are supplied in bottles of 100 (NDC 0228-3116-11). 60 mg – Size 2 capsule with light green opaque cap and body, printed with and 3091 on both the cap and body in black ink. capsules are supplied in bottles of 100 (NDC 0228-3091-11). 75 mg – Size 1 capsule with brown opaque cap and body, printed with and 3117 on both the cap and body in black ink. capsules are supplied in bottles of 100 (NDC 0228-3117-11). 90 mg – Size 1 capsule with green opaque cap and body, printed with and 3092 on both the cap and body in black ink. capsules are supplied in bottles of 100 (NDC 0228-3092-11). 120 mg – Size 0 capsule with light blue opaque cap and body, printed with and 3093 on both the cap and body in black ink. capsules are supplied in bottles of 100 (NDC 0228-3093-11). Store at 25°C (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 tight, light-resistant container as defined in USP. Store
MORPHINE SULFATE Extended-Release capsules securely and dispose of properly [see Patient Counseling Information ( 17 )] . capsule image capsule image capsule image capsule image capsule image capsule image
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