FDA.reportPublic FDA data

FDA label b7b520dc-bad0-614f-e053-2995a90ae677

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
9f1c8703-0eb2-76f7-e053-2a95a90ac9bb
SPL ID
b7b520dc-bad0-614f-e053-2995a90ae677
Version
2
Effective date
2020-12-30
Source export date
2026-11-06
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-11-06/b0d9ca61dc485ebaf55e14a76d7d677668e40ef1e1978cdbcc4d73d58eba0b99/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 07:50:23

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 2 matching rows.

warnings

Liver warning This product contains acetaminophen. Severe liver damage may occur if you take ■ more than 6 caplets in 24 hours, which is the maximum daily amount ■ with other drugs containing acetaminophen ■ 3 or more alcoholic drinks every day while using this product

warnings and cautions

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.

Reported adverse events (FAERS/openFDA)#

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