S4 | Prescription Only

What Schedule Is TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN?

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN scheduling and classification across Australia, United States, and international jurisdictions. Also known as Tramadol Hydrochloride and Acetaminophen.

S4 in Australia Source: FDA Updated April 2026

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (Tramadol Hydrochloride and Acetaminophen) 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)
  • SIRA reportable: Flagged for reporting under NSW workers compensation

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 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN 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 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (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 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN 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.

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Check TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN scheduling, interactions, and compliance across your claimant's 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.