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: Reliable 1 Laboratories LLC
Product type: HUMAN OTC DRUG
SPL set ID: 25626b46-78f8-7226-e054-00144ff8d46c
SPL ID: 2bc81e27-90e2-930d-e063-6394a90a699d
Version: 10
Effective date: 2025-01-15
Source export date: 2026-09-28
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/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:36:59

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 · 13 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		Reliable 1 Laboratories LLC	openfda.manufacturer_name
ndc	package	69618-010-10	openfda.package_ndc
ndc	package	69618-010-01	openfda.package_ndc
ndc	product	69618-010	openfda.product_ndc
ndc11	package	69618001001	derived:openfda.package_ndc
ndc11	package	69618001010	derived:openfda.package_ndc
rxcui		313782	openfda.rxcui
spl id		2bc81e27-90e2-930d-e063-6394a90a699d	id
spl set id		25626b46-78f8-7226-e054-00144ff8d46c	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.