Hydrocodone and Aspirin

Addiction, Abuse, and Misuse

Hydrocodone Bitartrate and Aspirin 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 Hydrocodone Bitartrate and Aspirin Tablets, and monitor all patients regularly for the development of these behaviors and conditions [see WARNINGS].

Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)

To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products [see WARNINGS]. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to

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complete a REMS-compliant education program,

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counsel patients and/or their caregivers , with every prescription, on safe use, serious risks, and storage, and disposal of these products,

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emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and

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consider other tools to improve patient, household, and community safety.