FDA.reportPublic FDA data

FDA label 5579a14f-6524-2bee-e063-6394a90a2334

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
08f5742a-7bc8-5786-e063-6294a90a347d
SPL ID
5579a14f-6524-2bee-e063-6394a90a2334
Version
6
Effective date
2026-06-30
Source export date
2026-09-28
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:26:36

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 2 matching rows.

warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take  more than 4,000 mg of acetaminophen in 24 hours  with other drugs containing acetaminophen  3 or more alcoholic drinks every day while using this product

warnings

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:  skin reddening  blisters  rash If a skin reaction occurs, stop use and seek medical help right away

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.