Acetaminophen AND Codeine Phosphate · Regulatory label update

FDA supplemental approval: Acetaminophen AND Codeine Phosphate (REMS)

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

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AI Summary

This is an FDA supplemental approval action for a REMS (Risk Evaluation and Mitigation Strategy) on acetaminophen–codeine phosphate tablets in three strength formulations, approved 18 June 2026. The record documents regulatory compliance with risk management requirements but contains no clinical trial data, efficacy measures, or safety outcomes.

What was studied

Regulatory label update. Intervention: Acetaminophen and codeine phosphate tablets: 300 mg acetaminophen + 15 mg codeine phosphate; 300 mg acetaminophen + 30 mg codeine phosphate; 300 mg acetaminophen + 60 mg codeine phosphate.

Key findings

FDA approved REMS supplement for acetaminophen 300 mg + codeine phosphate 15 mg, 30 mg, and 60 mg tablet formulations Sponsor: SPECGX LLC; application ANDA040419 (Abbreviated New Drug Application)

Safety

This is a regulatory approval record and does not contain clinical trial results, efficacy data, or safety outcome measures. Sample size, patient population, and comparative efficacy or safety data are not reported.

Who this may help

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

Plain-language summary

FDA supplemental approval for REMS (Risk Evaluation and Mitigation Strategy) on acetaminophen–codeine phosphate tablets; confirms regulatory compliance but does not report clinical efficacy or comparative benefit data.

Study design

As stated by the source record.

InterventionAcetaminophen and codeine phosphate tablets: 300 mg acetaminophen + 15 mg codeine phosphate; 300 mg acetaminophen + 30 mg codeine phosphate; 300 mg acetaminophen + 60 mg codeine phosphate

Reported figures

Quoted from the source exactly as published.

Approval status date2026-06-18

Caveats

This is a regulatory approval record and does not contain clinical trial results, efficacy data, or safety outcome measures.
No information on REMS requirements, implementation, or clinical indications is provided in the source.
Sample size, patient population, and comparative efficacy or safety data are not reported.
Record does not assess clinical benefit or risk relative to alternative analgesics.

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 action record; no clinical study design reported.

Directness

insufficient

Record addresses regulatory compliance only; no clinical outcomes measured.

Consistency

insufficient

Single regulatory approval action; consistency with other evidence not assessed.

Risk of bias

insufficient

Not applicable to regulatory approval documentation.

Sample adequacy

insufficient

No clinical population or sample size data in regulatory record.

Source abstract

Drugs@FDA record for application ANDA040419. This is a regulatory action record, not a clinical study. Brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE. Active ingredient: ACETAMINOPHEN AND CODEINE PHOSPHATE. Sponsor: SPECGX LLC. Submission type: SUPPL (supplement). Submission class: REMS. Approval status date: 2026-06-18. Products: ACETAMINOPHEN AND CODEINE PHOSPHATE, TABLET, ORAL, ACETAMINOPHEN 300MG + CODEINE PHOSPHATE 30MG; ACETAMINOPHEN AND CODEINE PHOSPHATE, TABLET, ORAL, ACETAMINOPHEN 300MG + CODEINE PHOSPHATE 60MG; ACETAMINOPHEN AND CODEINE PHOSPHATE, TABLET, ORAL, ACETAMINOPHEN 300MG + CODEINE PHOSPHATE 15MG.

Follow from this

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

SpecgxAcetaminophen AND Codeine Phosphate