Butalbital, Acetaminophen, Caffeine, AND Codeine Phosphate · Regulatory label update

FDA supplemental approval: Fioricet With Codeine (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 regulatory action approving a supplemental REMS submission for Fioricet With Codeine, a combination of butalbital, acetaminophen, caffeine, and codeine phosphate. The record documents the approval date and formulations but does not contain clinical trial results, efficacy data, or comparative evidence.

What was studied

Regulatory label update.

Key findings

REMS supplement approved on 2026-06-18 for Fioricet With Codeine Two formulations approved: 300 mg acetaminophen + 50 mg butalbital + 40 mg caffeine + 30 mg codeine, and 325 mg acetaminophen + 50 mg butalbital + 40 mg caffeine + 30 mg codeine

Safety

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

Who this may help

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

Plain-language summary

FDA supplemental approval of a Risk Evaluation and Mitigation Strategy (REMS) for an existing combination analgesic; this is a regulatory action, not a clinical evidence report.

Reported figures

Quoted from the source exactly as published.

Approval date2026-06-18

Formulation 1Acetaminophen 300 mg + Butalbital 50 mg + Caffeine 40 mg + Codeine Phosphate 30 mg

Formulation 2Acetaminophen 325 mg + Butalbital 50 mg + Caffeine 40 mg + Codeine Phosphate 30 mg

Caveats

This record does not contain clinical trial results, efficacy data, or safety outcomes.
The REMS submission type indicates risk mitigation requirements but specific REMS details are not described in this record.
No comparative effectiveness data or patient outcomes are reported.
Record does not clarify whether this is an initial approval or a modification to an existing REMS program.

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 action record, not a clinical study.

Directness

insufficient

Record does not report clinical trial data or comparative outcomes.

Consistency

insufficient

No clinical data or comparative evidence presented in record.

Risk of bias

insufficient

This is a regulatory approval action, not a primary research study.

Sample adequacy

insufficient

No patient population or trial data reported in this record.

Source abstract

Drugs@FDA record for application ANDA076560. This is a regulatory action record, not a clinical study. Brand name: FIORICET WITH CODEINE. Active ingredient: BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE. Sponsor: LGM PHARMA. Submission type: SUPPL (supplement). Submission class: REMS. Approval status date: 2026-06-18. Products: BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE, CAPSULE, ORAL, ACETAMINOPHEN 300MG + BUTALBITAL 50MG + CAFFEINE 40MG + CODEINE PHOSPHATE 30MG; BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE, CAPSULE, ORAL, ACETAMINOPHEN 325MG + BUTALBITAL 50MG + CAFFEINE 40MG + CODEINE PHOSPHATE 30MG.

Follow from this

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

Butalbital, Acetaminophen, Caffeine, AND Codeine PhosphateLGM Pharma