FDA label af1e5459-2fd9-4c0f-af63-bea42e73c14d

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: 8816ec3c-2a26-4bd5-9ba6-8f7fce999470
SPL ID: af1e5459-2fd9-4c0f-af63-bea42e73c14d
Version: 2
Effective date: 2010-09-09
Source export date: 2026-10-12
Source partition: 13
Source file: https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 03:00:11

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		af1e5459-2fd9-4c0f-af63-bea42e73c14d	id
spl set id		8816ec3c-2a26-4bd5-9ba6-8f7fce999470	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 : Do not exceed recommended dosage. Do not give to children under 12 years of age. Liver Toxicity may occur if: Recommended dosage is exceeded Used with other products containing acetaminophen Used with moderate amounts of alcohol Alcohol Warning : If you consume 3 or more alcoholic drinks, ask your doctor whether you should take acetaminophen or other pain relievers. Acetaminophen may cause liver damage. Sore Throat Warning : If sore throat is severe, persists for more than two days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.

Reported adverse events (FAERS/openFDA)#

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