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: Bryant Ranch Prepack
Product type: HUMAN OTC DRUG
SPL set ID: f6dc5576-9ba3-436c-87f5-8d0d6258adef
SPL ID: 4534cfd2-5503-42bd-829b-5db07a93ce4b
Version: 6
Effective date: 2024-10-07
Source export date: 2026-10-30
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/2026-10-30/eb45a4bb6908a5d117668eac8da5ce490c753c3f9b68298758ef131307d1d264/drug-label-0009-of-0014.json.zip
Source manifest SHA-256: b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
Import run: 20261102T182004Z
Imported at: 2026-11-02 19:17:27

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	211544	derived:openfda.application_number
application number		ANDA211544	openfda.application_number
brand name		ACETAMINOPHEN	openfda.brand_name
generic name		ACETAMINOPHEN	openfda.generic_name
manufacturer name		Bryant Ranch Prepack	openfda.manufacturer_name
ndc	package	71335-1340-3	openfda.package_ndc
ndc	package	71335-1340-6	openfda.package_ndc
ndc	package	71335-1340-4	openfda.package_ndc
ndc	package	71335-1340-2	openfda.package_ndc
ndc	package	71335-1340-1	openfda.package_ndc
ndc	package	71335-1340-5	openfda.package_ndc
ndc	package	71335-1340-7	openfda.package_ndc
ndc	product	71335-1340	openfda.product_ndc
ndc11	package	71335134006	derived:openfda.package_ndc
ndc11	package	71335134001	derived:openfda.package_ndc
ndc11	package	71335134003	derived:openfda.package_ndc
ndc11	package	71335134004	derived:openfda.package_ndc
ndc11	package	71335134005	derived:openfda.package_ndc
ndc11	package	71335134007	derived:openfda.package_ndc
ndc11	package	71335134002	derived:openfda.package_ndc
rxcui		1148399	openfda.rxcui
spl id		4534cfd2-5503-42bd-829b-5db07a93ce4b	id
spl set id		f6dc5576-9ba3-436c-87f5-8d0d6258adef	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 everyday 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.