FDA.reportPublic FDA data

FDA label c84aa6c7-3e51-4b6a-9fee-e6af3856f0ae

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
058cdaf3-ed98-44b2-9ecc-fd810dcac12e
SPL ID
c84aa6c7-3e51-4b6a-9fee-e6af3856f0ae
Version
1
Effective date
2014-06-23
Source export date
2026-11-06
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/2026-11-06/b00a73f24c6ff050408c570063640e3d80d1f71dfc9a165d1cf072a25659445a/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 06:58:39

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.