FDA.reportPublic FDA data

FDA label 1a180cf7-e3df-a675-e063-6294a90abdbc

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
5f11cb62-9eec-5ba9-e053-2a91aa0aa4e5
SPL ID
1a180cf7-e3df-a675-e063-6294a90abdbc
Version
5
Effective date
2024-06-04
Source export date
2026-08-08
Source partition
8
Source file
https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-08/d256baae5644161bb821f95aa5c984626cd3cdfa52f9ac98031354c0c686ab3e/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
b39f3b00ad50d2e1b32aaf429248c6081e8799b35bce715b4fccb8cfa1ac4546
Import run
20260810T161303Z
Imported at
2026-08-10 17:16:27

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 4,000 mg in 24 hours, which is the maximum daily amount child takes more than 5 tablets in 24 hours, which is the maximum daily amount taken with other drugs containing acetaminophen adult has 3 or more alcoholic drinks while using this product