Morphine Sulfate 15 MG Oral Tablet
1 INDICATIONS AND USAGE Morphine Sulfate Tablets are indicated for the management of: • adult and pediatric patients weighing at least 50 kg and above with acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. • adults with chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use : Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, [see Warnings and Precautions ( 5.1 )] , reserve Morphine Sulfate Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): • Have not been tolerated or are not expected to be tolerated, • Have not provided adequate analgesia or are not expected to provide adequate analgesia Morphine Sulfate Tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadeq uate. Morphine Sulfate Tablets are opioid agonists indicated for the management of: • adults and pediatric patients weighing 50 kg and above with acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. • adults with chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use ( 1 ) Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration ( 5.1 ) , reserve Morphine Sulfate Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): • Have not been tolerated or are not expected to be tolerated, • Have not provided adequate analgesia or are not expected to provide adequate analgesia Morphine Sulfate Tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.
West-Ward Pharmaceuticals Corp
ROUND WHITE 54 733
54 733 ROUND WHITE
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Morphine Sulfate 15 MG Oral Tablet
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16 HOW SUPPLIED/STORAGE AND HANDLING
MORPHINE SULFATE Tablets 15 mg: Each tablet contains 15 mg
MORPHINE SULFATE, USP (equivalent to 11.25 mg morphine) and is a white, biconvex tablet scored on one side and product identification “54” over “733” debossed on the other side . NDC 0054-0235-24: 100 (10 x 10) Unit-Dose Tablets NDC 0054-0235-25: Bottle of 100 Tablets 30 mg: Each tablet contains 30 mg
MORPHINE SULFATE, USP (equivalent to 22.5 mg morphine) and is a white, biconvex tablet scored on one side and product identification “54” over “262” debossed on the other side. NDC 0054-0236-24: 100 (10 x 10) Unit-Dose Tablets NDC 0054-0236-25: Bottle of 100 Tablets Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. Store
MORPHINE SULFATE Tablets securely and dispose of properly [see Patient Counseling Information ( 17 )].
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