FDA label 31c4de05-74c3-ddc3-e063-6394a90a9388

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: d5d49146-665e-4a93-e053-2995a90aca59
SPL ID: 31c4de05-74c3-ddc3-e063-6394a90a9388
Version: 5
Effective date: 2025-04-02
Source export date: 2026-11-06
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/2026-11-06/97001096994db9ca8cee114e6c3bb5298d3c573158ffc1ab8692d82e76a3eb40/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 06:56:20

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 2 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		31c4de05-74c3-ddc3-e063-6394a90a9388	id
spl set id		d5d49146-665e-4a93-e053-2995a90aca59	set_id

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