FDA.reportPublic FDA data

Acetaminophen

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)

Brand name
Acetaminophen
Generic name
ACETAMINOPHEN
Manufacturer
WAL-MART STORES INC
Product type
HUMAN OTC DRUG
SPL set ID
e34d07b5-ccbb-cd14-e053-2a95a90a394b
SPL ID
464fe001-f74a-8ac0-e063-6394a90ae5d7
Version
6
Effective date
2025-12-19
Source export date
2026-11-06
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-11-06/2233cb6af8c6b55a5e4a05449e8db0d2f259f3c061d5d001b654a8bea1cc1db2/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 07:54:59
Harmonized routes table
Harmonized routes
ORAL

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

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.