ACETAMINOPHEN AND CODEINE- acetaminophen and codeine tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J)

Available from:

NuCarePharmaceuticals, Inc.

INN (International Name):

ACETAMINOPHEN

Composition:

ACETAMINOPHEN 300 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Acetaminophen and Codeine Phosphate Tablets is indicated for the management of mild to moderate pain where treatment with an opioid is appropriate and for which alternative treatments are inadequate. 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] - 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 is contraindicated in: - Patients with significant respiratory depression [see WARNINGS ]. - Patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see WARNINGS ]. - Postoperative pain management in children who have undergone tonsillectomy and/or adenoidectomy [see WARNINGS ]. - Patients with known or suspe

Product summary:

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: Bottles of 4 NDC 68071-3059-4 Bottles of 6 NDC 68071-3059-6 Bottles of 12 NDC 68071-3059-2 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. 12-2016-04

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ACETAMINOPHEN AND CODEINE- ACETAMINOPHEN AND CODEINE TABLET
NUCAREPHARMACEUTICALS, INC.
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ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP
300 MG/30 MG
CIII
RX ONLY
PRESCRIBING INFORMATION BOXED WARNING
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING
RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID
WITHDRAWAL SYNDROME; DEATH RELATED TO ULTRA-RAPID METABOLISM
OF CODEINE TO MORPHINE; HEPATOTOXICITY; CYTOCHROME P450 2D6
INTERACTION; 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].
NEONATAL OPIOID WITHDRAWAL SYNDROME
PROLONGED USE OF ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS DURING
PREGNANCY CAN
RESULT IN NEONATAL OPIOID WITHDRAWAL SYNDROME, WHICH MAY BE
LIFE-THREATENING IF NOT
RECOGNIZED AND TREATED, AND REQUIRES MANAGEMENT ACCORDING TO PROTOCOLS
DEVELOPED BY
NEONATOLOGY EXPERTS. IF OPIOID USE IS REQUIRED FOR A PROLONGED PERIOD
IN A PREGNANT WOMAN,
ADVISE THE PATIENT OF THE RISK OF NEONATAL OPIOID WITHDRAWAL SYNDROME
AND ENSURE THAT
APPROPRIATE TREATMENT WILL BE AVAILABLE [SEE WARNINGS].
DEATH RELATED TO ULTRA-RAPID METABOLISM OF CODEINE TO MORPHINE