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).
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.