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 TABLET EXTENDED RELEASE
Manufacturer
TIME CAP LABORATORIES, INC.
Product type
HUMAN OTC DRUG
SPL set ID
cd4d0ad4-7206-94c8-e053-2a95a90aaa14
SPL ID
02a5f067-4b67-ecc7-e063-6294a90a92c3
Version
3
Effective date
2024-03-19
Source export date
2026-08-01
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/63703fa640102c69d41ceeb8d73f46d0a0be448587814b2aeca60b43bed7e054/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:39:43
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 · 1 matching rows.

warnings

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. 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.