FDA.reportPublic FDA data

FDA label ac825d18-735f-6052-46fa-14a834979c8c

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
5a251962-305d-101b-e7fa-cb6b50c20a4f
SPL ID
ac825d18-735f-6052-46fa-14a834979c8c
Version
1
Effective date
2010-08-26
Source export date
2026-10-22
Source partition
7
Source file
https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-22/54e9c48e60446f01ef435f186a51c63f4eb19a752379c30779f6422194b8316c/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
5de9d3c3492926d1703b492ae4d29b036ac5be73edfcb92a6cd5eb95a2acef9c
Import run
20261023T001338Z
Imported at
2026-10-23 00:56:33

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: adult takes more than 12 caplets in 24 hours, which is the maximum daily amount child takes more than 5 doses in 24 hours taking with other drugs containing acetaminophen adult has 3 or more alcoholic drinks every day while using this product Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, condult a doctor promptly.

Reported adverse events (FAERS/openFDA)#

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