8 HR Arthritis Pain

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: 8 HR Arthritis Pain
Generic name: ACETAMINOPHEN
Manufacturer: Dr. Reddy's Laboratories Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 8e780c23-997c-b960-226e-954037baad4b
SPL ID: 2b89d8dc-aa00-5564-20a9-269c26d7d14f
Version: 1
Effective date: 2026-07-01
Source export date: 2026-10-12
Source partition: 14
Source file: https://download.open.fda.gov/drug/label/drug-label-0014-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/acb9b4700b9af1bdda1c389c7b35bfe38fd6d1a62aa48d17832812be4029b84f/drug-label-0014-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 03:12:35

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 · 14 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		8 HR Arthritis Pain	openfda.brand_name
generic name		ACETAMINOPHEN	openfda.generic_name
manufacturer name		Dr. Reddy's Laboratories Inc.	openfda.manufacturer_name
ndc	package	75907-430-01	openfda.package_ndc
ndc	package	75907-430-40	openfda.package_ndc
ndc	product	75907-430	openfda.product_ndc
ndc11	package	75907043040	derived:openfda.package_ndc
ndc11	package	75907043001	derived:openfda.package_ndc
rxcui		1148399	openfda.rxcui
spl id		2b89d8dc-aa00-5564-20a9-269c26d7d14f	id
spl set id		8e780c23-997c-b960-226e-954037baad4b	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.