Extra Strength 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: Extra Strength Acetaminophen
Generic name: ACETAMINOPHEN
Manufacturer: TIME CAP LABORATORIES, INC.
Product type: HUMAN OTC DRUG
SPL set ID: 58840cf4-aceb-c7cf-e063-6294a90a5ff4
SPL ID: 58840cb3-368d-c7a4-e063-6294a90a2d3f
Version: 3
Effective date: 2026-06-01
Source export date: 2026-09-28
Source partition: 4
Source file: https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:26:46

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		Extra Strength Acetaminophen	openfda.brand_name
generic name		ACETAMINOPHEN	openfda.generic_name
manufacturer name		TIME CAP LABORATORIES, INC.	openfda.manufacturer_name
ndc	package	49483-673-73	openfda.package_ndc
ndc	product	49483-673	openfda.product_ndc
ndc11	package	49483067373	derived:openfda.package_ndc
rxcui		198440	openfda.rxcui
spl id		58840cb3-368d-c7a4-e063-6294a90a2d3f	id
spl set id		58840cf4-aceb-c7cf-e063-6294a90a5ff4	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 4,000 mg of acetaminophen in 24 hours 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.