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: Prostat First Aid
Product type: HUMAN OTC DRUG
SPL set ID: 3ba313db-bafe-1947-e063-6294a90a528c
SPL ID: 3ba313db-baff-1947-e063-6294a90a528c
Version: 1
Effective date: 2025-08-05
Source export date: 2026-09-28
Source partition: 10
Source file: https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:08:57

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		M013	openfda.application_number
brand name		Acetaminophen	openfda.brand_name
generic name		ACETAMINOPHEN	openfda.generic_name
manufacturer name		Prostat First Aid	openfda.manufacturer_name
ndc	package	58228-0061-1	openfda.package_ndc
ndc	product	58228-0061	openfda.product_ndc
ndc11	package	58228006101	derived:openfda.package_ndc
rxcui		313782	openfda.rxcui
spl id		3ba313db-baff-1947-e063-6294a90a528c	id
spl set id		3ba313db-bafe-1947-e063-6294a90a528c	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 maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children. Severe liver damage may occur if: adutls take more than 4000mg of acetaminophen in 24 hours child takes more than 5 doses in 24 hours, which is the maximum daily amount. taken with other drugs containing acetaminophen adult has 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 ad seek medical medical help right away

Reported adverse events (FAERS/openFDA)#

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