Is Tylenol 3 schedule II opioid? A comprehensive look at drug scheduling

October 11, 2025 •

3 min read

In the United States, drugs are classified into five schedules by the DEA based on their potential for abuse and medical use. This system leads to a frequent question: is Tylenol 3 a schedule II opioid, or does it fall under a different category?

Quick Summary

Tylenol 3 is classified as a Schedule III controlled substance, not Schedule II. Its specific formulation with a limited amount of codeine lowers its abuse potential compared to Schedule II opioids.

Key Points

Tylenol 3's Schedule: Tylenol 3 is a Schedule III controlled substance, not a Schedule II opioid.
Reason for Scheduling: The classification is based on its specific formula, which combines a limited quantity of codeine (less than 90mg per unit) with a non-narcotic analgesic.
Difference in Abuse Potential: Schedule III drugs have a lower abuse potential and risk of physical dependence compared to Schedule II drugs.
Examples of Schedule II Opioids: Schedule II opioids include pure codeine, fentanyl, and morphine, which carry a high potential for abuse and severe dependence.
Prescription Rules: The scheduling dictates prescription regulations; Schedule III drugs may be refilled, whereas Schedule II drugs require a new prescription each time.
Codeine Alone vs. Combination: Pure codeine is a Schedule II opioid, but when combined with other ingredients in limited quantities, as in Tylenol 3, it becomes a Schedule III substance.

No, Tylenol 3 is not a Schedule II opioid; it is a Schedule III controlled substance. This distinction is critical because it reflects a difference in abuse potential, risk of dependence, and prescribing regulations. Understanding the classification of combination drugs like Tylenol 3 requires looking at the specific ingredients and their quantities, as defined by the federal Controlled Substances Act (CSA) and enforced by the Drug Enforcement Administration (DEA).

The Controlled Substances Act (CSA) Explained

The Controlled Substances Act is the primary federal law that regulates the manufacture, importation, possession, use, and distribution of certain substances. It divides these substances into five categories, or 'schedules,' based on a drug's potential for abuse, accepted medical use, and potential for psychological or physical dependence. The DEA uses several factors to determine a drug's schedule, including:

The drug's actual or relative potential for abuse.
Scientific evidence of its pharmacological effect.
The state of current scientific knowledge regarding the substance.
Its history and current pattern of abuse.
The scope, duration, and significance of abuse.
The public health risk.
The psychic or physiological dependence liability.

Why Tylenol 3 is a Schedule III Opioid

The key to Tylenol 3's classification lies in its combination of ingredients. Tylenol 3 contains acetaminophen and a limited quantity of codeine. The DEA specifies that products containing not more than 90 milligrams of codeine per dosage unit, when combined with a non-narcotic ingredient, are classified as Schedule III.

This specific combination leads to a lower potential for abuse and dependence compared to pure codeine. While it still carries a risk of dependence, particularly high psychological dependence, it does not meet the criteria for the more restrictive Schedule II category.

The Difference Between Schedule II and Schedule III

Understanding why Tylenol 3 is Schedule III requires a clear picture of the differences between Schedule II and Schedule III substances. The DEA's system is based on a hierarchy of abuse potential and dependence risk.

Schedule II Substances

Schedule II drugs are defined as substances with a high potential for abuse that can lead to severe psychological or physical dependence. Examples of Schedule II opioids include:

Pure codeine.
Oxycodone (OxyContin).
Fentanyl.
Hydromorphone (Dilaudid).
Morphine.

Notably, combination products containing hydrocodone, such as Vicodin, were previously Schedule III but were reclassified as Schedule II in 2014, reflecting a higher abuse potential than codeine combination products like Tylenol 3. Prescriptions for Schedule II drugs are subject to strict regulations, including no refills without a new prescription.

Schedule III Substances

In contrast, Schedule III drugs have a lower potential for abuse than Schedule I or II substances. Abuse may lead to moderate or low physical dependence or high psychological dependence. This category includes:

Tylenol with codeine (containing less than 90 mg per unit).
Ketamine.
Anabolic steroids.

Schedule III prescriptions are less restrictive than Schedule II. For instance, a prescription can be refilled up to five times within a six-month period.

Comparison Table: Schedule II vs. Schedule III


Feature	Schedule II	Schedule III
Abuse Potential	High	Moderate to Low
Dependence Risk	Severe psychological or physical dependence	Moderate or low physical dependence; high psychological dependence
Accepted Medical Use	Yes, with severe restrictions	Yes
Prescription Rules	No refills without a new prescription; more stringent regulations	Up to 5 refills within 6 months
Examples	Morphine, pure codeine, oxycodone, fentanyl, hydrocodone combination products	Tylenol with codeine, ketamine, anabolic steroids

Risks and Responsible Use

Even though Tylenol 3 is a Schedule III controlled substance, it is not without risk. It still contains an opioid, and prolonged use can lead to dependence, tolerance, and withdrawal symptoms. Misuse can also lead to overdose and significant health problems, including liver damage due to the acetaminophen component. As with any controlled medication, it is essential to follow a healthcare provider's instructions carefully.

Conclusion: The Importance of Drug Classification

The scheduling of Tylenol 3 as a Schedule III opioid is a direct reflection of its composition, which has a lower abuse potential than more potent opioids or pure codeine. It is not a Schedule II opioid. This federal classification provides a framework for regulating controlled substances based on their potential for harm and dependence. For patients, understanding this distinction is crucial for safe and responsible medication use. Always consult your healthcare provider and pharmacist if you have questions about a prescription or its classification.

For more detailed information on federal drug scheduling, visit the DEA's website [https://www.dea.gov/drug-information/drug-scheduling].

Frequently Asked Questions

Schedule II drugs have a high potential for abuse and severe dependence, with accepted but restricted medical uses. Schedule III drugs have a lower potential for abuse and risk of dependence compared to Schedule II, with moderate to low physical dependence but potentially high psychological dependence.

Yes, Tylenol 3 contains codeine, which is an opioid. Its specific formulation combines this opioid with a non-narcotic pain reliever, acetaminophen.

Pure codeine is classified as Schedule II due to its high potential for abuse. However, Tylenol 3 combines a limited amount of codeine with acetaminophen, which lowers its overall abuse potential and places it in the less restrictive Schedule III category.

Prescribing rules for Schedule II drugs are very strict, typically requiring a new written prescription for each fill and no refills. Schedule III drugs, in contrast, can be refilled up to five times within a six-month period.

Vicodin (hydrocodone/acetaminophen) was reclassified from Schedule III to Schedule II in 2014, reflecting its higher abuse potential compared to Tylenol 3.

Yes, even Schedule III drugs like Tylenol 3 carry a risk of dependence, particularly high psychological dependence, and can lead to addiction if misused.

The DEA considers a drug's potential for abuse, its accepted medical use, its history and pattern of abuse, and the public health risks associated with it, among other factors.