FDA.reportPublic FDA data

FDA label 2b8521e4-3009-4212-bc2d-230321189125

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
2522df3b-a599-4bab-b7cc-315f40f7cca4
SPL ID
2b8521e4-3009-4212-bc2d-230321189125
Version
3
Effective date
2019-06-14
Source export date
2026-10-12
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/f40eac55ff4c5d55c3d8bbc5766ea7e21e4196960cfb4703b96a406b491c0cd5/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:30:44

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 Do not exceed recommended dosage Liver warning: This product contains Acetaminophen. Sever liver damage may occur if Adult takes more than 6 doses in 24 hours, which is the maximum daily amount Child takes more than 5 doses in 24 hours Taken with other drugs containing Acetaminophen Adult has 3 or more alcoholic drinks everyday while using this product Do not give to children under 3 years of age or use for more than 10 days unless directed by a physician

Reported adverse events (FAERS/openFDA)#

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