FDA.reportPublic FDA data

FDA label 08c563b1-8efe-428b-bc73-ecc7318ee492

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
1b22a74e-8055-4388-ad74-d9b82213c9d6
SPL ID
08c563b1-8efe-428b-bc73-ecc7318ee492
Version
1
Effective date
2010-10-20
Source export date
2026-08-01
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/054d07cb7b0dcd436e53c5bdecbb921b48860de8ff372c4a586941aa9821a276/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:21:27

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

LIVER WARNING This product contains acetaminophen. severe liver damage may occur if adult takes more than 6 doses in 24 hours which is the maximum daily amount. child takes more than 5 doses in 24 hours which is the maximum daily amount. taken with other drugs containing acetaminophen. adult has 3 or more alcoholic drinks everyday while using this product.