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: Bryant Ranch Prepack
Product type: HUMAN OTC DRUG
SPL set ID: 61ea1796-b9c7-4cb9-9a36-60943f884875
SPL ID: 61ea1796-b9c7-4cb9-9a36-60943f884875
Version: 101
Effective date: 2024-04-05
Source export date: 2026-10-12
Source partition: 9
Source file: https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:25:18

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 · 24 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		Bryant Ranch Prepack	openfda.manufacturer_name
ndc	package	71335-9746-2	openfda.package_ndc
ndc	package	71335-9746-4	openfda.package_ndc
ndc	package	71335-9746-3	openfda.package_ndc
ndc	package	71335-9746-5	openfda.package_ndc
ndc	package	71335-9746-1	openfda.package_ndc
ndc	package	71335-9746-7	openfda.package_ndc
ndc	package	71335-9746-6	openfda.package_ndc
ndc	product	71335-9746	openfda.product_ndc
ndc11	package	71335974606	derived:openfda.package_ndc
ndc11	package	71335974605	derived:openfda.package_ndc
ndc11	package	71335974607	derived:openfda.package_ndc
ndc11	package	71335974603	derived:openfda.package_ndc
ndc11	package	71335974604	derived:openfda.package_ndc
ndc11	package	71335974601	derived:openfda.package_ndc
ndc11	package	71335974602	derived:openfda.package_ndc
rxcui		1148399	openfda.rxcui
spl id		61ea1796-b9c7-4cb9-9a36-60943f884875	id
spl set id		61ea1796-b9c7-4cb9-9a36-60943f884875	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.