Codeine Cough Syrup Schedule Classification
Codeine cough syrup is classified as either Schedule II or Schedule III depending on whether it is a single-ingredient codeine product (Schedule II) or a combination product with acetaminophen or other ingredients (Schedule III). 1
DEA Schedule Classification Details
The Drug Enforcement Administration (DEA) classifies codeine-containing products under the Comprehensive Drug Abuse Prevention and Control Act of 1970 based on abuse potential: 1
- Schedule II: Pure codeine without combination ingredients (30-60 mg every 4-6 hours) 1
- Schedule III: Codeine combined with acetaminophen (APAP) or other non-opioid ingredients (30-60 mg codeine component every 4-6 hours) 1
Important Clinical Context
Codeine is NOT recommended as first-line therapy for cough suppression due to its significant adverse effect profile (drowsiness, nausea, constipation, physical dependence) and lack of efficacy advantage over safer alternatives. 2, 3
Why Schedule Classification Matters Clinically:
- Schedule II products require stricter prescribing controls, no refills, and written prescriptions in most jurisdictions 1
- Schedule III products allow for some refills and may have less stringent prescribing requirements 1
- Schedule classifications can change over time based on evolving abuse patterns and regulatory assessments 1
Critical Prescribing Considerations
The schedule classification should not be the primary factor in deciding whether to prescribe codeine for cough. Instead, consider: 2, 3
- Dextromethorphan (60 mg) has equivalent efficacy with a superior safety profile and should be used first-line 2, 3
- Simple remedies like honey and lemon are as effective as pharmacological treatments for benign viral cough 2, 3
- If opioids are necessary, alternatives like pholcodine, hydrocodone, or dihydrocodeine have better side effect profiles than codeine 2
Common Pitfall to Avoid:
Do not assume that Schedule III codeine combinations are "safer" or more appropriate than Schedule II pure codeine—both should be avoided as first-line antitussives due to lack of efficacy advantage and significant adverse effects compared to non-opioid alternatives. 2, 3, 4