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 LABORATORIES, INC
Product type: HUMAN OTC DRUG
SPL set ID: 2569383a-4a05-4ddb-852e-b37e487ffcde
SPL ID: 7d3e2e18-1dee-4000-e053-2a91aa0aeefe
Version: 2
Effective date: 2018-12-17
Source export date: 2026-10-27
Source partition: 1
Source file: https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-27/2c7d3f7bcea1543046130e07dcbaf7eea5fb0ce23f7faa6458d1c6d80c3fa0c3/drug-label-0001-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 19:44:02

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 · 15 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		part343	openfda.application_number
brand name		ACETAMINOPHEN	openfda.brand_name
generic name		ACETAMINOPHEN	openfda.generic_name
manufacturer name		TIME CAP LABORATORIES, INC	openfda.manufacturer_name
ndc	package	49483-342-00	openfda.package_ndc
ndc	package	49483-342-01	openfda.package_ndc
ndc	package	49483-342-10	openfda.package_ndc
ndc	product	49483-342	openfda.product_ndc
ndc11	package	49483034200	derived:openfda.package_ndc
ndc11	package	49483034210	derived:openfda.package_ndc
ndc11	package	49483034201	derived:openfda.package_ndc
rxcui		198440	openfda.rxcui
spl id		7d3e2e18-1dee-4000-e053-2a91aa0aeefe	id
spl set id		2569383a-4a05-4ddb-852e-b37e487ffcde	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 · 2 matching rows.

warnings

Warnings; Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:more than 8 tablets in 24 hours, which is the maximum daily amount; 3 or more alcoholic drinks every day while using this product; with other drugs containing acetaminophen. Overdose warning: Taking more than the recommended dose (0verdose) may cause liver damage. in case of overdose, get medical help or contact a Poison Control Center (1-800-222-1221) right way. Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

warnings table

<table border="0" width="100%"> <tbody> <tr> <td> <paragraph>Warnings; Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:more than 8 tablets in 24 hours, which is the maximum daily amount; 3 or more alcoholic drinks every day while using this product; with other drugs containing acetaminophen. </paragraph> <paragraph>Overdose warning: Taking more than the recommended dose (0verdose) may cause liver damage. in case of overdose, get medical help or contact a Poison Control Center (1-800-222-1221) right way. Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms. </paragraph> </td> </tr> </tbody> </table>

Reported adverse events (FAERS/openFDA)#

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