FDA label 84277043-9176-4afb-86d5-555ff82b92eb

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
ce02f11a-e875-49de-bb38-ab4a2fd6f469
SPL ID
84277043-9176-4afb-86d5-555ff82b92eb
Version
3
Effective date
2019-09-09
Source export date
2026-10-12
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b939c18fdf51df171cf60ce5558819d08ac66bb16bb9991d48cbec91028d783e/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:35:41

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 This product contains acetaminophen. Severe liver damage may occur if your child takes • more than 5 doses in 24 hours, which is the maximum daily amount • with other drugs containing acetaminophen

Reported adverse events (FAERS/openFDA)#

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