S3 | Pharmacy Medicine

What Schedule Is Promethazine?

Promethazine scheduling and classification across Australia, United States, and international jurisdictions. Also known as DBL PROMETHAZINE HYDROCHLORIDE 50mg/2mL injection BP ampoule, PHENERGAN ELIXIR promethazine hydrochloride 1mg/mL bottle (reformulation), PHENERGAN promethazine hydrochloride 10mg tablet blister pack (reformulation).

S3 in Australia Source: TGA, FDA Updated April 2026

Promethazine (DBL PROMETHAZINE HYDROCHLORIDE 50mg/2mL injection BP ampoule) 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) - has FDA Boxed Warning
  • 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 Promethazine

Promethazine 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 Promethazine (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

Medical Disclaimer: This content is for informational purposes for claims professionals and care workers. It is not medical advice. Always consult a qualified healthcare professional for clinical decisions. Drug information is sourced from TGA, FDA, MHRA, PBS, NICE, and CDC databases and may not reflect the latest updates. AllMeds does not replace clinical judgement.