Schedule Classification of Tylenol with Codeine
Tylenol with codeine (acetaminophen/codeine) is classified as a Schedule III controlled substance under the Controlled Substances Act. 1
Understanding Drug Scheduling Classification
The Drug Enforcement Administration (DEA) classifies controlled substances based on their potential for abuse and accepted medical use. Tylenol with codeine falls into Schedule III, which indicates:
- Moderate to low potential for physical and psychological dependence
- Accepted medical use in the United States
- Lower abuse potential compared to Schedule II substances
This classification can be verified in the table provided in the American College of Emergency Physicians clinical policy, which explicitly lists "Codeine/APAP" (acetaminophen with codeine) as a Schedule III medication 1.
Comparison with Other Opioid Medications
It's important to understand how Tylenol with codeine compares to other common pain medications:
| Medication | Schedule | Notes |
|---|---|---|
| Codeine/APAP (Tylenol with codeine) | III | Contains acetaminophen and codeine |
| Codeine alone | II | Higher abuse potential than combination product |
| Hydrocodone/APAP | II | Rescheduled from III to II in 2014 [2,3] |
| Oxycodone/APAP | II | Higher potency than codeine combinations |
Clinical Implications of Schedule III Classification
The Schedule III classification of Tylenol with codeine has several practical implications for prescribing:
- Prescriptions may be refilled up to 5 times within 6 months
- Prescriptions can be called in to pharmacies (unlike Schedule II medications)
- Less stringent record-keeping requirements compared to Schedule II substances
- May be more accessible to patients than Schedule II alternatives
Important Considerations When Prescribing
When prescribing Tylenol with codeine, clinicians should be aware of:
- Initial dosing typically ranges from 30-60 mg of the codeine component every 4-6 hours as needed for pain 1
- Maximum daily dose should not exceed 360 mg of codeine or 4000 mg of acetaminophen
- Risk of hepatotoxicity due to the acetaminophen component
- Potential for respiratory depression, especially in opioid-naïve patients
- Risk of constipation and other opioid-related side effects
Historical Context
It's worth noting that while Tylenol with codeine remains Schedule III, hydrocodone combination products (previously Schedule III) were rescheduled to Schedule II in October 2014 due to concerns about their abuse potential 2, 3. This highlights the evolving regulatory approach to opioid medications based on ongoing assessment of their risks and benefits.