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: TIME CAP LABS INC
Product type: HUMAN OTC DRUG
SPL set ID: c193dbc0-cc80-4a7c-aa29-457a20edf835
SPL ID: 2d9fddd5-a3d6-ac0c-e063-6394a90a89bd
Version: 7
Effective date: 2025-02-08
Source export date: 2026-09-28
Source partition: 8
Source file: https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:57:33

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	openfda.brand_name
generic name		ACETAMINOPHEN	openfda.generic_name
manufacturer name		TIME CAP LABS INC	openfda.manufacturer_name
ndc	package	49483-340-10	openfda.package_ndc
ndc	package	49483-340-01	openfda.package_ndc
ndc	product	49483-340	openfda.product_ndc
ndc11	package	49483034010	derived:openfda.package_ndc
ndc11	package	49483034001	derived:openfda.package_ndc
rxcui		313782	openfda.rxcui
spl id		2d9fddd5-a3d6-ac0c-e063-6394a90a89bd	id
spl set id		c193dbc0-cc80-4a7c-aa29-457a20edf835	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 • adult takes more than 4,000 mg 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 and seek medical help right away.

Reported adverse events (FAERS/openFDA)#

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