Acetaminophen · 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

The FDA approved a supplemental REMS application for acetaminophen–codeine phosphate tablets (300 mg acetaminophen paired with 15 mg, 30 mg, or 60 mg codeine phosphate) on 18 June 2026. This is a regulatory action modifying risk management requirements, not a clinical efficacy or safety trial; the record does not include trial results, efficacy data, or comparative outcomes.

What was studied

Regulatory label update.

Key findings

Three strength formulations approved: acetaminophen 300 mg + codeine phosphate 15 mg, 30 mg, and 60 mg tablets

Safety

This record does not contain clinical trial results, efficacy data, or safety trial outcomes.

Who this may help

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

Plain-language summary

FDA supplemental approval of a REMS (Risk Evaluation and Mitigation Strategy) for an existing acetaminophen–codeine combination; this is a regulatory action, not a clinical evidence report, and does not contain trial data or efficacy claims.

Reported figures

Quoted from the source exactly as published.

Approval date2026-06-18

ANDA number088629

Acetaminophen dose300 mg

Codeine phosphate doses approved15 mg, 30 mg, 60 mg

Caveats

This record does not contain clinical trial results, efficacy data, or safety trial outcomes.
No information on comparators, control groups, or comparative effectiveness.
Record describes REMS approval only; the clinical basis for the risk mitigation strategy is not included.
No sample size, endpoints, or statistical analysis reported.

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

This is a regulatory approval record, not a clinical study.

Directness

insufficient

Record does not report clinical outcomes or comparative efficacy.

Consistency

insufficient

No clinical data or comparisons provided in this regulatory record.

Risk of bias

insufficient

Regulatory approval does not include bias assessment of clinical trials.

Sample adequacy

insufficient

Record contains no sample size or clinical trial population data.

Source abstract

Drugs@FDA record for application ANDA088629. This is a regulatory action record, not a clinical study. Brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE. Active ingredient: ACETAMINOPHEN. Sponsor: ANI PHARMS. Submission type: SUPPL (supplement). Submission class: REMS. Approval status date: 2026-06-18. Products: ACETAMINOPHEN AND CODEINE PHOSPHATE, TABLET, ORAL, ACETAMINOPHEN 300MG + CODEINE PHOSPHATE 15MG; ACETAMINOPHEN AND CODEINE PHOSPHATE, TABLET, ORAL, ACETAMINOPHEN 300MG + CODEINE PHOSPHATE 30MG; 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.

AcetaminophenANI Pharms