FDA.reportPublic FDA data

FDA label 1114224d-5c96-43e0-aa89-bb7b1550be47

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
9bf4ca22-2546-4803-a199-b7d782e04a97
SPL ID
1114224d-5c96-43e0-aa89-bb7b1550be47
Version
2
Effective date
2021-07-19
Source export date
2026-10-12
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b25dad4aaef9c88f0e827394a34fbbd1ce7d71422fa46b5d1e123befad498c1d/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:52:54

Warnings cross-check#

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

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings: Allergy Alert: Acetaminophen may cause a severe skin reactions. Symptoms may include: • Skin reddening •Blisters •Rash • If a skin reaction occurs, stop use and seek medical right away. Liver Warning: This product contains an acetaminophen. Severe liver damage may occur if you take: • more than 8 tablets in 24 hours, which is the maximum daily amount • 3 or more alcoholic drinks every day while using this product • take more or for a longer time than directed

Reported adverse events (FAERS/openFDA)#

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