Codeine sulfate 15 MG Oral Tablet
1 INDICATIONS AND USAGE Codeine Sulfate Tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Limitations of Use Because of the risks of ADDICTION, ABUSE, AND MISUSE with opioids, even at recommended doses [see Warnings and Precautions ( 5.1 )], reserve Codeine 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 . Codeine Sulfate Tablets are an opioid agonist, indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. ( 1 ) Limitations of Use ( 1 ) Because of the risks of ADDICTION, ABUSE, AND MISUSE with opioids, even at recommended doses, reserve Codeine 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.
West-Ward Pharmaceuticals Corp.
ROUND WHITE 54 613 15
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codeine sulfate 30 MG Oral Tablet
West-Ward Pharmaceuticals Corp.
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16 HOW SUPPLIED/STORAGE AND HANDLING Codeine Sulfate Tablets USP 15 mg Tablet: supplied as white to off-white biconvex tablets with “15” debossed on the scored side and “54 613” debossed on the other side. NDC 0054-0243-24: 100 (4 x 25) Unit-Dose Tablets 30 mg Tablet: supplied as white to off-white biconvex tablets with “30” debossed on the scored side and “54 783” debossed on the other side. NDC 0054-0244-24: 100 (4 x 25) Unit-Dose Tablets NDC 0054-0244-25: Bottle of 100 Tablets 60 mg Tablet: supplied as white to off-white biconvex tablets with “60” debossed on the scored side and “54 412” debossed on the other side. NDC 0054-0245-25: Bottle of 100 Tablets Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture and light. Dispense in well-closed container as defined in the USP/NF. Blisters are not child-resistant. Use child-resistant closure if dispensing to outpatient.
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