Vicodin

Addiction, Abuse, and Misuse

Hydrocodonebitartrate and acetaminophen 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 hydrocodonebitartrate and acetaminophen 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 hydrocodonebitartrate and acetaminophen tablets . Monitor for respiratory depression especially during initiation of hydrocodonebitartrate and acetaminophen tablets or following a dose increase [see WARNINGS].

Accidental Ingestion

Accidental ingestion of hydrocodonebitartrate and acetaminophen tablets , especially by children, can result in a fatal overdose of hydrocodonebitartrate and acetaminophen tablets [see WARNINGS].