S4 | Prescription Only

What Schedule Is ACETAMINOPHEN AND CODEINE PHOSPHATE?

ACETAMINOPHEN AND CODEINE PHOSPHATE scheduling and classification across Australia, United States, and international jurisdictions. Also known as ACETAMINOPHEN AND CODEINE PHOSPHATE.

S4 in Australia Source: FDA Updated April 2026

ACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN AND CODEINE PHOSPHATE) is classified as S4 (Prescription Only Medicine - requires a valid prescription from an authorised prescriber) under the Therapeutic Goods Administration (TGA) in Australia. It is FDA approved in the United States.

Key Takeaways

  • Australia (TGA): S4 - Prescription Only Medicine - requires a valid prescription from an authorised prescriber
  • United States (FDA): Approved (Rx only) - has FDA Boxed Warning
  • Risk level: Low (2 points)

Scheduling by Jurisdiction

Jurisdiction Regulatory Body Classification Status
Australia TGA (Therapeutic Goods Administration) S4 Not PBS listed
United States FDA / DEA Rx only (not DEA scheduled) FDA approved

What S4 Means for ACETAMINOPHEN AND CODEINE PHOSPHATE

ACETAMINOPHEN AND CODEINE PHOSPHATE is classified as S4 under the TGA Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP). Prescription Only Medicine - requires a valid prescription from an authorised prescriber.

Schedule 4 Prescribing Requirements

  • Prescribing: Requires a valid prescription from a registered medical practitioner, dentist, or authorised prescriber.
  • Dispensing: Must be dispensed by a pharmacist against a valid prescription.
  • Repeats: Repeat prescriptions are permitted as specified by the prescriber.

Claims and Workers Compensation Implications

When ACETAMINOPHEN AND CODEINE PHOSPHATE (S4) appears on a claimant's medication list, the scheduling classification affects how claims professionals should assess and manage the claim.

As a Schedule 4 prescription medicine, claims professionals should verify that ACETAMINOPHEN AND CODEINE PHOSPHATE is being prescribed for the compensable injury and review duration against clinical guidelines. As a CNS depressant, it may affect work capacity and return-to-work timelines.

Check this medication against your full medication list

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Related Resources

Important: This page is general health information, not personal medical advice. If you have questions about your medication — including starting it, stopping it, changing the dose, or combining it with something else — speak with your doctor or pharmacist. For an emergency or suspected overdose, call your local emergency number or poison information service immediately. Information is drawn from regulator and clinical guideline sources (TGA, FDA, MHRA, NICE, PBS, CDC); see our methodology for details.