PurgenLabs 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: PurgenLabs Acetaminophen
Generic name: ACTAMINOPHEN
Manufacturer: Advanced Rx LLC
Product type: HUMAN OTC DRUG
SPL set ID: 915c4608-af1b-4119-8291-4ce9fd701d76
SPL ID: a8ae2ac6-f3b4-458b-acbb-fa4ff186503c
Version: 1
Effective date: 2024-06-28
Source export date: 2026-09-28
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/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:39:14

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 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M012	openfda.application_number
brand name		PurgenLabs Acetaminophen	openfda.brand_name
generic name		ACTAMINOPHEN	openfda.generic_name
manufacturer name		Advanced Rx LLC	openfda.manufacturer_name
ndc	package	80513-230-08	openfda.package_ndc
ndc	product	80513-230	openfda.product_ndc
ndc11	package	80513023008	derived:openfda.package_ndc
rxcui		307684	openfda.rxcui
spl id		a8ae2ac6-f3b4-458b-acbb-fa4ff186503c	id
spl set id		915c4608-af1b-4119-8291-4ce9fd701d76	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 maximurr daily dose of fhis product is 6 tablespoonfuls in 24 hours. Severe liver damage may occur if you take • more than 8 tablespoonfuls (4,000 mg of acetaminophen) in 24 hours • 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.