Acetaminophen AND Ibuprofen · Regulatory label update

FDA supplemental approval: Acetaminophen AND Ibuprofen Back Pain (Labeling)

U.S. Food and Drug Administration · June 10, 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 for labeling of a fixed-dose combination tablet containing acetaminophen 250 mg and ibuprofen 125 mg, approved by Aurobindo Pharma on 10 June 2026. The record does not contain clinical trial results, efficacy data, or safety evidence; it documents only the regulatory action itself.

What was studied

Regulatory label update.

Key findings

Safety

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

Who this may help

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

Plain-language summary

FDA supplemental approval for labeling of a fixed-dose combination product; does not contain clinical trial data or efficacy evidence.

Reported figures

Quoted from the source exactly as published.

Acetaminophen dose250 mg

Ibuprofen dose125 mg

Approval date2026-06-10

Caveats

This record does not contain clinical trial results, efficacy outcomes, or safety data.
The record documents only the regulatory approval action and product formulation.
No comparator arm, control group, or patient outcome metrics are reported.
Labeling changes approved are not specified in the source text.

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, not a clinical study.

Directness

insufficient

Regulatory record does not report clinical outcomes or trial data.

Consistency

insufficient

No comparative efficacy data provided in this record.

Risk of bias

insufficient

Not applicable to a labeling approval record.

Sample adequacy

insufficient

No clinical trial or study population described.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Drugs@FDA record for application ANDA218359. This is a regulatory action record, not a clinical study. Brand name: ACETAMINOPHEN AND IBUPROFEN BACK PAIN. Active ingredient: ACETAMINOPHEN AND IBUPROFEN. Sponsor: AUROBINDO PHARMA LTD. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-06-10. Products: ACETAMINOPHEN AND IBUPROFEN, TABLET, ORAL, ACETAMINOPHEN 250MG + IBUPROFEN 125MG.

Follow from this

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

Acetaminophen AND IbuprofenAurobindo Pharma