FDA.reportPublic FDA data

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
2026-08-01
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/d245bd7ce31d1d8ed63276109973402ece6c44860774da30f25b731cd7418983/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:35:40

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.