Zyfrel

Risk of Medication Errors

Ensure accuracy when prescribing, dispensing, and administering Zyfrel Oral Solution. Dosing errors due to confusion between mg and mL, and other Hydrocodone Bitartrate and Acetaminophen Oral Solutions of different concentrations can result in accidental overdose and death [see WARNINGS, DOSAGE AND ADMINISTRATION].

Addiction, Abuse, and Misuse

Zyfrel Oral Solution exposes 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 Zyfrel Oral Solution, and monitor all patients regularly for the development of these behaviors or conditions [see WARNINGS].

Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of Zyfrel Oral Solution. Follow patients for signs of respiratory depression, especially during initiation of Zyfrel Oral Solution or following a dose increase [see WARNINGS].

Accidental Ingestion

Accidental ingestion of Zyfrel Oral Solution, especially by children, can result in a fatal overdose of Zyfrel Oral Solution [see WARNINGS].

Neonatal Opioid Withdrawal Syndrome