FDA label 085b7ce1-fa07-470c-e063-6294a90a162b

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: fafa1c47-2ba7-4a4d-8db2-66eed89621d4
SPL ID: 085b7ce1-fa07-470c-e063-6294a90a162b
Version: 2
Effective date: 2024-06-13
Source export date: 2026-09-28
Source partition: 10
Source file: https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:09:34

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		085b7ce1-fa07-470c-e063-6294a90a162b	id
spl set id		fafa1c47-2ba7-4a4d-8db2-66eed89621d4	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. The maximum daily dose of this product is 9 tablets (2925 mg) in 24 hours. Severe liver damage may occur if you take: more than 3000mg of acetaminophen in 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 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.