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: Asclemed USA, Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 4ef6bc2b-03cf-474f-bb9e-dbb5792ec197
SPL ID: 2ef14964-4fa1-9fb6-e063-6294a90aff36
Version: 2
Effective date: 2025-02-24
Source export date: 2026-09-28
Source partition: 8
Source file: https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:53:59

Harmonized routes table
Harmonized routes
ORAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 22 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	215486	derived:openfda.application_number
application number		ANDA215486	openfda.application_number
brand name		Acetaminophen	openfda.brand_name
generic name		ACETAMINOPHEN TABLET EXTENDED RELEASE	openfda.generic_name
manufacturer name		Asclemed USA, Inc.	openfda.manufacturer_name
ndc	package	76420-914-26	openfda.package_ndc
ndc	package	76420-914-42	openfda.package_ndc
ndc	package	76420-914-05	openfda.package_ndc
ndc	package	76420-914-40	openfda.package_ndc
ndc	package	76420-914-60	openfda.package_ndc
ndc	package	76420-914-01	openfda.package_ndc
ndc	product	76420-914	openfda.product_ndc
ndc11	package	76420091442	derived:openfda.package_ndc
ndc11	package	76420091460	derived:openfda.package_ndc
ndc11	package	76420091405	derived:openfda.package_ndc
ndc11	package	76420091440	derived:openfda.package_ndc
ndc11	package	76420091401	derived:openfda.package_ndc
ndc11	package	76420091426	derived:openfda.package_ndc
rxcui		1148399	openfda.rxcui
spl id		2ef14964-4fa1-9fb6-e063-6294a90aff36	id
spl set id		4ef6bc2b-03cf-474f-bb9e-dbb5792ec197	set_id
unii		362O9ITL9D	openfda.unii

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.

Reported adverse events (FAERS/openFDA)#

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