Country: United States
Language: English
Source: NLM (National Library of Medicine)
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J)
Preferred Pharmaceuticals, Inc.
ACETAMINOPHEN
ACETAMINOPHEN 300 mg
ORAL
PRESCRIPTION DRUG
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, even at recommended doses (see WARNINGS ), reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics). Acetaminophen and codeine phosphate tablets are contraindicated for: Acetaminophen and codeine phosphate tablets are contraindicated in patients with: Controlled Substance Acetaminophen and codeine phosphate tablets contain codeine. Codeine in combination with acetaminophen, is a Schedule III controlled substance. Abuse Acetaminophen and codeine phosphate tablets contain codeine, a substance with a high potential for abuse similar to other opioids, including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone, and
Acetaminophen and Codeine Phosphate Tablets, USP 300 mg /30 mg are white, round, flat, beveled edged tablets debossed “IP 33” on obverse and “3” on reverse. They are available as follows: Bottle of 15 - 68788-9403-1 Bottle of 20 - 68788-9403-2 Bottle of 30 - 68788-9403-3 Bottle of 60 - 68788-9403-6 Bottle of 90 - 68788-9403-9 Store Acetaminophen and Codeine Phosphate Tablets, USP 300 mg/30 mg 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. Manufactured by: Amneal Pharmaceuticals of NY LLC Brookhaven, NY 11719 Rev. 07-2017-06 Repackaged by Preferred Pharmaceuticals, Inc
Abbreviated New Drug Application
ACETAMINOPHEN AND CODEINE- ACETAMINOPHEN AND CODEINE TABLET PREFERRED PHARMACEUTICALS, INC. ---------- ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP CIII 300 MG/30 MG RX ONLY BOXED WARNING WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; ULTRA-RAPID METABOLISM OF CODEINE AND OTHER RISK FACTORS FOR LIFE- THREATENING RESPIRATORY DEPRESSION IN CHILDREN; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES; HEPATOTOXICITY; AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS ADDICTION, ABUSE AND MISUSE ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS EXPOSE PATIENTS AND OTHER USERS TO THE RISKS OF OPIOID ADDICTION, ABUSE AND MISUSE, WHICH CAN LEAD TO OVERDOSE AND DEATH. ASSESS EACH PATIENT’S RISK PRIOR TO PRESCRIBING ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, AND MONITOR ALL PATIENTS REGULARLY FOR THE DEVELOPMENT OF THESE BEHAVIORS AND CONDITIONS (SEE WARNINGS). LIFE-THREATENING RESPIRATORY DEPRESSION SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR WITH USE OF ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS. MONITOR FOR RESPIRATORY DEPRESSION, ESPECIALLY DURING INITIATION OF ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS OR FOLLOWING A DOSE INCREASE (SEE WARNINGS). ACCIDENTAL INGESTION ACCIDENTAL INGESTION OF ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, ESPECIALLY BY CHILDREN, CAN RESULT IN A FATAL OVERDOSE OF ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS (SEE WARNINGS). ULTRA-RAPID METABOLISM OF CODEINE AND OTHER RISK FACTORS FOR LIFE-THREATENING RESPIRATORY DEPRESSION IN CHILDREN LIFE-THREATENING RESPIRATORY DEPRESSION AND DEATH HAVE OCCURRED IN CHILDREN WHO RECEIVED CODEINE. MOST OF THE REPORTED CASES OCCURRED FOLLOWING TONSILLECTOMY AND/OR ADENOIDECTOMY AND MANY OF THE CHILDREN HAD EVIDENCE OF BEING ULTRA-RAPID METABOLIZERS OF CODEINE DUE TO A CYP2D6 POLYMORPHISM (SEE WARNINGS, PRECAUTIONS; INFORMATION FOR PATIENTS/CAREGIVERS, NURSING MOTHERS). ACETAMINOPHEN AND CODEINE PHOSPHATE Read the complete document