acetaminophen and codeine phosphate tablet
INDICATIONS AND USAGE Acetaminophen and codeine phosphate 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, which can occur at any dosage or duration ( see WARNINGS ), reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics) Have not provided adequate analgesia, or are not expected to provide adequate analgesia, Have not been tolerated, or are not expected to be tolerated. Acetaminophen and codeine phosphate 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.
Mallinckrodt Inc.
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HOW SUPPLIED Each
ACETAMINOPHEN AND CODEINE PHOSPHATE Tablet USP 300 mg/60 mg tablet contains acetaminophen 300 mg and codeine phosphate 60 mg. It is available as a round, white to off-white tablet debossed with “4” on one side and an Boxed M on the other side. NDC: 63629-3031-0: 100 Tablets in a BOTTLE NDC: 63629-3031-1: 30 Tablets in a BOTTLE NDC: 63629-3031-2: 120 Tablets in a BOTTLE NDC: 63629-3031-3: 60 Tablets in a BOTTLE NDC: 63629-3031-4: 90 Tablets in a BOTTLE NDC: 63629-3031-5: 40 Tablets in a BOTTLE NDC: 63629-3031-6: 20 Tablets in a BOTTLE NDC: 63629-3031-7: 112 Tablets in a BOTTLE NDC: 63629-3031-8: 84 Tablets in a BOTTLE NDC: 63629-3031-9: 15 Tablets in a BOTTLE Store
ACETAMINOPHEN AND CODEINE PHOSPHATE tablets at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant container as defined in the USP. Store
ACETAMINOPHEN AND CODEINE PHOSPHATE tablets securely and dispose of properly (see PRECAUTIONS, INFORMATION FOR PATIENTS). Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504
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