Acetaminophen AND Codeine Phosphate · Regulatory label update

FDA supplemental approval: Acetaminophen AND Codeine Phosphate (REMS)

U.S. Food and Drug Administration · June 18, 2026

Regulatory Update Why this matters to you Expert discussion

An action by a regulator. Authoritative on labelling and availability.

AI Summary

This is an FDA supplemental approval action for acetaminophen and codeine phosphate tablets (300 mg / 60 mg oral formulation) issued on 2026-06-18 under the REMS (Risk Evaluation and Mitigation Strategy) submission class. The record confirms regulatory authorization but does not contain clinical trial results, comparative efficacy data, or safety outcomes.

What was studied

Regulatory label update.

Key findings

Product: acetaminophen 300 mg and codeine phosphate 60 mg, oral tablet formulation Sponsor: Strides Pharma International Submission type: Supplemental REMS approval

Safety

This record does not contain clinical trial results, efficacy data, or safety outcomes; it is an administrative approval action only. Sponsor: Strides Pharma International

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

FDA supplemental approval action for an existing drug-drug combination product with REMS requirements; does not report clinical trial data or comparative efficacy.

Reported figures

Quoted from the source exactly as published.

Active ingredient dosesacetaminophen 300 mg + codeine phosphate 60 mg

Approval date2026-06-18

Caveats

This record does not contain clinical trial results, efficacy data, or safety outcomes; it is an administrative approval action only.
REMS requirements and specific risk mitigation measures are not detailed in this record.
No sample size, patient population, comparator, or primary/secondary endpoints reported.
Original approval history and indication(s) for use are not stated in this supplemental record.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

insufficient

Regulatory record; no clinical study design reported.

Directness

insufficient

Record does not specify clinical outcome or endpoint assessed.

Consistency

insufficient

No comparative trial data or reproducibility information provided.

Risk of bias

insufficient

Regulatory approval action; clinical trial bias assessment not applicable.

Sample adequacy

insufficient

Regulatory record contains no enrollment or sample size data.

Source abstract

Drugs@FDA record for application ANDA089828. This is a regulatory action record, not a clinical study. Brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE. Active ingredient: ACETAMINOPHEN AND CODEINE PHOSPHATE. Sponsor: STRIDES PHARMA INTL. Submission type: SUPPL (supplement). Submission class: REMS. Approval status date: 2026-06-18. Products: ACETAMINOPHEN AND CODEINE PHOSPHATE, TABLET, ORAL, ACETAMINOPHEN 300MG + CODEINE PHOSPHATE 60MG.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Acetaminophen AND Codeine PhosphateStrides Pharma Intl