codeine sulfate 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. L i m i t ations of Use: Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [ s ee 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 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. 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: Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration ( 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 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.
lannett company, inc.
ROUND WHITE LCI 3 0
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16 HOW SUPPLIED/STORAGE AND HANDLING
CODEINE SULFATE Tablets, USP 15 mg Tablet: supplied as white, round, uncoated tablets scored on one side, debossed “15” on the scored side and “LCI” on the other side. NDC 0527-1727-91: Unit-Dose, 25 Tablets per Blister Card, 4 Blister Cards per Carton 30 mg Tablet: supplied as white, round, uncoated tablets scored on one side, debossed “30” on the scored side and “LCI” on the other side. NDC 0527-1698-91: Unit-Dose, 25 Tablets per Blister Card, 4 Blister Cards per Carton NDC 0527-1698-01: Bottle of 100 Tablets 60 mg Tablet: supplied as white, round, uncoated tablets scored on one side, debossed “1699” on the scored side and “LCI” on the other side. NDC 0527-1699-01: Bottle of 100 Tablets Storage Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP/NF. Blisters are not child-resistant. Use child-resistant closure if dispensing to outpatient. Store
CODEINE SULFATE tablets securely and dispose of properly.
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