ACETAMINOPHEN 325 MG

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 325 MG
Generic name: ACETAMINOPHEN
Manufacturer: Proficient Rx LP
Product type: HUMAN OTC DRUG
SPL set ID: 6794830a-7856-464d-84be-c8b253cf41ac
SPL ID: d25dcece-12ac-4e85-a6ec-fd71d1dc1fde
Version: 5
Effective date: 2025-10-01
Source export date: 2026-10-27
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-27/977776a6cc37ec1c77259da8a93ae161850a3aa120341096e5a03428b84d016b/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 21:01:24

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 · 17 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M013	openfda.application_number
brand name		ACETAMINOPHEN 325 MG	openfda.brand_name
generic name		ACETAMINOPHEN	openfda.generic_name
manufacturer name		Proficient Rx LP	openfda.manufacturer_name
ndc	package	71205-456-30	openfda.package_ndc
ndc	package	71205-456-00	openfda.package_ndc
ndc	package	71205-456-90	openfda.package_ndc
ndc	package	71205-456-60	openfda.package_ndc
ndc	product	71205-456	openfda.product_ndc
ndc11	package	71205045660	derived:openfda.package_ndc
ndc11	package	71205045630	derived:openfda.package_ndc
ndc11	package	71205045600	derived:openfda.package_ndc
ndc11	package	71205045690	derived:openfda.package_ndc
rxcui		313782	openfda.rxcui
spl id		d25dcece-12ac-4e85-a6ec-fd71d1dc1fde	id
spl set id		6794830a-7856-464d-84be-c8b253cf41ac	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 • adult takes more than 4,000 mg in 24 hours, which is the maximum daily amount • child takes more than 5 tablets in 24 hours, which is the maximum daily amount • taken with other drugs containing acetaminophen • adult has 3 or more alcoholic drinks while using this product

Reported adverse events (FAERS/openFDA)#

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