Aspirin · Regulatory label update

FDA supplemental approval: Butalbital, Aspirin, Caffeine, 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 application establishing a Risk Evaluation and Mitigation Strategy (REMS) for a fixed-dose oral capsule containing butalbital, aspirin, caffeine, and codeine phosphate (50/325/40/30 mg). This is a regulatory classification action; the record does not contain clinical trial results, efficacy data, or safety outcomes.

What was studied

Regulatory label update.

Key findings

REMS supplement approved for butalbital, aspirin, caffeine, and codeine phosphate combination on 2026-06-18 Formulation: capsule for oral use, 50 mg butalbital + 325 mg aspirin + 40 mg caffeine + 30 mg codeine phosphate

Safety

This is a regulatory approval record, not a clinical study; no clinical trial results, efficacy endpoints, or safety data are reported. The record does not include information on the specific REMS requirements, contraindications, or safety monitoring mandated by the approval.

Who this may help

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

Plain-language summary

FDA supplemental approval action establishing REMS (Risk Evaluation and Mitigation Strategy) for a combination analgesic containing codeine; regulatory classification only, not a clinical efficacy study.

Reported figures

Quoted from the source exactly as published.

Approval date2026-06-18

Butalbital dose50 mg

Aspirin dose325 mg

Caffeine dose40 mg

Codeine phosphate dose30 mg

Caveats

This is a regulatory approval record, not a clinical study; no clinical trial results, efficacy endpoints, or safety data are reported.
REMS approval indicates risk mitigation requirements but does not establish clinical superiority or comparative benefit versus other analgesics.
The record does not include information on the specific REMS requirements, contraindications, or safety monitoring mandated by the approval.
No patient population, sample size, or outcome data are provided.

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

REMS approval does not report clinical outcomes or direct efficacy data.

Consistency

insufficient

Single regulatory action; no comparative or replication data provided.

Risk of bias

insufficient

Regulatory approval; bias assessment not applicable to this record type.

Sample adequacy

insufficient

No patient sample reported; this is an approval action, not a trial.

Source abstract

Drugs@FDA record for application ANDA075351. This is a regulatory action record, not a clinical study. Brand name: BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE. Active ingredient: ASPIRIN. Sponsor: NOVITIUM PHARMA. Submission type: SUPPL (supplement). Submission class: REMS. Approval status date: 2026-06-18. Products: BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE, CAPSULE, ORAL, ASPIRIN 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.

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