FDA.reportPublic FDA data

FDA label 66c2a0a3-f42e-d46c-e053-2991aa0a7ef4

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
41292088-026f-4cfe-a52b-956660d9f12e
SPL ID
66c2a0a3-f42e-d46c-e053-2991aa0a7ef4
Version
8
Effective date
2018-03-06
Source export date
2026-09-28
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/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:21:52

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 an adult or child 12 years and older takes more than 6 doses in 24 hours, which is the maximum daily amount taken with other drugs containing acetaminophen an adult takes 3 or more alcoholic drinks everyday while using this product Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. For rectal use only

Reported adverse events (FAERS/openFDA)#

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