Is acetaminophen (Tylenol)-codeine a controlled substance and what is its schedule?

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Last updated: March 20, 2025View editorial policy

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From the Guidelines

Acetaminophen-codeine is a controlled substance classified as Schedule III under the U.S. Controlled Substances Act, as indicated in the study published in the Annals of Emergency Medicine 1. The scheduling of acetaminophen-codeine as a Schedule III controlled substance is based on its potential for abuse, although it is considered to have a lower risk compared to Schedule I or II substances. Key points to consider about acetaminophen-codeine include:

  • It contains codeine, an opioid with potential for dependence and abuse
  • The medication is classified as Schedule III due to its limited potential for abuse compared to Schedule I or II substances
  • Common brand names include Tylenol with Codeine and Capital with Codeine
  • As a Schedule III medication, prescriptions can be filled up to five times within six months from the date of issue, but a new prescription is required after that period
  • Patients should be aware that this medication requires proper medical supervision due to its potential for side effects, including drowsiness, constipation, and respiratory depression, as noted in the study 1. The codeine component works by binding to opioid receptors in the brain to reduce pain perception, while acetaminophen works through different mechanisms to reduce pain and fever. It is essential to follow the recommended dosing guidelines, which include an initial dose of 30-60 mg of codeine, with a maximum acetaminophen component of 325 mg or less per pill, as specified in the study 1.

From the Research

Acetaminophen-Codeine as a Controlled Substance

  • Acetaminophen-codeine is a combination medication used for pain management, with codeine being an opioid analgesic 2.
  • The scheduling of acetaminophen-codeine is not explicitly stated in the provided studies, but it can be inferred that it is a controlled substance due to the presence of codeine, an opioid 3, 4.
  • The Drug Enforcement Administration (DEA) has rescheduled hydrocodone combination products from Schedule III to Schedule II, but the scheduling of acetaminophen-codeine is not directly mentioned 5, 4, 6.

Schedule of Acetaminophen-Codeine

  • The exact schedule of acetaminophen-codeine is not specified in the provided studies, but it is likely to be a Schedule III controlled substance due to the presence of codeine, which is a less potent opioid compared to hydrocodone 3, 4.
  • The studies suggest that acetaminophen-codeine is often used as an alternative to hydrocodone combination products, which were rescheduled to Schedule II 4, 6.
  • The scheduling of acetaminophen-codeine may vary depending on the specific formulation and dosage, but it is generally considered a controlled substance due to the presence of codeine 2.

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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