S3 | Pharmacy Medicine

What Schedule Is ACETAMINOPHEN, DIPHENHYDRAMINE HCL?

ACETAMINOPHEN, DIPHENHYDRAMINE HCL scheduling and classification across Australia, United States, and international jurisdictions. Also known as Pain Reliever PM Extra Strength.

S3 in Australia Source: FDA Updated April 2026

ACETAMINOPHEN, DIPHENHYDRAMINE HCL (Pain Reliever PM Extra Strength) is classified as S3 (Pharmacist Only Medicine - available without a prescription but requires pharmacist involvement and may require consultation) under the Therapeutic Goods Administration (TGA) in Australia. It is FDA approved in the United States.

Key Takeaways

  • Australia (TGA): S3 - Pharmacist Only Medicine - available without a prescription but requires pharmacist involvement and may require consultation
  • United States (FDA): Approved (Rx only)
  • Risk level: Low (2 points)

Scheduling by Jurisdiction

Jurisdiction Regulatory Body Classification Status
Australia TGA (Therapeutic Goods Administration) S3 Not PBS listed
United States FDA / DEA Rx only (not DEA scheduled) FDA approved

What S3 Means for ACETAMINOPHEN, DIPHENHYDRAMINE HCL

ACETAMINOPHEN, DIPHENHYDRAMINE HCL is classified as S3 under the TGA Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP). Pharmacist Only Medicine - available without a prescription but requires pharmacist involvement and may require consultation.

Claims and Workers Compensation Implications

When ACETAMINOPHEN, DIPHENHYDRAMINE HCL (S3) appears on a claimant's medication list, the scheduling classification affects how claims professionals should assess and manage the claim.

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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.