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Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Addiction, Abuse, and Misuse

Inform patients that the use of Vicodin (Hydrocodone Bitartrate and Acetaminophen) tablets, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death. Instruct patients not to share Vicodin with others and to take steps to protect hydrocodone bitartrate and acetaminophen tablets from theft or misuse.

Life-Threatening Respiratory Depression

Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting Vicodin (Hydrocodone Bitartrate and Acetaminophen) or when the dosage is increased, and that it can occur even at recommended dosages. Advise patients how to recognize respiratory depression and to seek medical attention if breathing difficulties develop.

Accidental Ingestion

Inform patients that accidental ingestion, especially by children, may result in respiratory depression or death. Instruct patients to take steps to store Vicodin (Hydrocodone Bitartrate and Paracetamol) securely and to dispose of unused Vicodin by flushing down the toilet.

Interactions with Benzodiazepines and Other CNS Depressants

Doctors should inform patients and caregivers that potentially fatal additive effects may occur if Vicodin (Hydrocodone Bitartrate with Acetaminophen) tablets are used with benzodiazepines and other CNS depressants, including alcohol, and not to use these concomitantly unless supervised by a healthcare provider.

Serotonin Syndrome

Physician have to inform patients that Vicodin could cause a rare but potentially life-threatening condition resulting from concomitant administration of serotonergic drugs. Warn patients of the symptoms of serotonin syndrome and to seek medical attention right away if symptoms develop. Instruct patients to inform their healthcare providers if they are taking, or plan to take serotonergic medications.

Monoamine Oxidase Inhibitor (MAOI) Interaction

Inform patients to avoid taking Vicodin (Hydrocodone Bitartrate with Acetaminophen) while using any drugs that inhibit monoamine oxidase. Patients should not start MAOIs while taking Vicodin.

Adrenal Insufficiency

Inform patients that Vicodin (Hydrocodone Bitartrate with Paracetamol) could cause adrenal insufficiency, a potentially life-threatening condition. Adrenal insufficiency may present with non-specific symptoms and signs such as nausea, anorexia, vomiting, fatigue, dizziness, weakness, and low blood pressure.

Advise patients to seek medical attention if they experience a constellation of these symptoms.

Important Administration Instructions

Instruct patients how to properly take Vicodin.

Maximum Daily Dose of Acetaminophen

Inform patients not to take more than 4000 milligrams of paracetamol per day. Advise patients to call their prescriber if they take more than the recommended dose.


Inform patients that Vicodin (Hydrocodone Bitartrate, Acetaminophen) tablets may cause orthostatic hypotension and syncope. Instruct patients how to recognize symptoms of low blood pressure and how to reduce the risk of serious consequences should hypotension occur (e.g., sit or lie down, carefully rise from a sitting or lying position).


Inform patients that anaphylaxis has been reported with ingredients contained in Vicodin, Vicodin ES, Vicodin HP. Advise patients how to recognize such a reaction and when to seek medical attention.

Manufactured and distributed by AbbVie, Mikart pharmaceutical companies and theit divisions.

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