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: NCS HealthCare of KY, LLC dba Vangard Labs
Product type: HUMAN OTC DRUG
SPL set ID: bb450552-728a-4675-b0a9-0fd2934f6c5e
SPL ID: d48fadc8-c402-4ecd-b8af-c1ea069eac71
Version: 11
Effective date: 2024-08-19
Source export date: 2026-10-12
Source partition: 6
Source file: https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/b25dad4aaef9c88f0e827394a34fbbd1ce7d71422fa46b5d1e123befad498c1d/drug-label-0006-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:45:09

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 · 15 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		505G(a)(3)	openfda.application_number
brand name		ACETAMINOPHEN	openfda.brand_name
generic name		ACETAMINOPHEN	openfda.generic_name
manufacturer name		NCS HealthCare of KY, LLC dba Vangard Labs	openfda.manufacturer_name
ndc	package	0615-8397-30	openfda.package_ndc
ndc	package	0615-8397-05	openfda.package_ndc
ndc	package	0615-8397-39	openfda.package_ndc
ndc	product	0615-8397	openfda.product_ndc
ndc11	package	00615839705	derived:openfda.package_ndc
ndc11	package	00615839730	derived:openfda.package_ndc
ndc11	package	00615839739	derived:openfda.package_ndc
rxcui		313782	openfda.rxcui
spl id		d48fadc8-c402-4ecd-b8af-c1ea069eac71	id
spl set id		bb450552-728a-4675-b0a9-0fd2934f6c5e	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. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children. Severe liver damage may occur if: adult takes more than 4,000 mg of acetaminophen in 24 hours. child takes more than 5 doses in 24 hours, which is the maximum daily amount taken with other drugs containing acetaminophen adult has 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.