8HR Arthritis Pain Relief — Tablet, Extended Release

Overview

Brand name

8HR Arthritis Pain Relief

Generic name

Acetaminophen

Dosage form

Tablet, Extended Release

Route

Oral

Marketing category

ANDA · ANDA

Labeler

LEADER/ Cardinal Health 110, Inc.

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

1

NDC product codes

3

Packages

4

Data completeness

76% of corroborating sources present

Active ingredients

Source: NDC Directory

Active ingredients and strengths as listed in the NDC Directory.
Ingredient	Strength	RxCUI	Monograph
Acetaminophen	650 mg/1	313782	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Tablet, Extended Release

Route of administration

Oral

Presentations

7

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

215486

Application type

ANDA · Abbreviated New Drug Application

Approval date

August 25, 2021

Sponsor

MARKSANS PHARMA

Products on application

1

Submissions recorded

1

Products approved under application 215486.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
215486-001	ACETAMINOPHEN	TABLET, EXTENDED RELEASE		ACETAMINOPHEN	Over-the-counter	—

Approval history

Source: Drugs@FDA

Most recent submissions on application 215486.
Type	No.	Action	Status	Date	Review
Original application	1		Approved	August 25, 2021	Standard

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260428). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260428 HUMAN OTC DRUG · 20250622 HUMAN OTC DRUG · 20250503

Indications and Usage

openFDA Drug Labeling

Uses temporarily relieves minor aches and pains due to: - minor pain of arthritis - muscular aches - backache - premenstrual and menstrual cramps - the common cold - headache - toothache temporarily reduces fever

Purpose

openFDA Drug Labeling

Purpose Pain reliever/ fever reducer

Dosage and Administration

openFDA Drug Labeling

Directions Do not take more than directed. See overdose warning adults take 2 caplets every 8 hours with water swallow whole; do not crush, chew, split, or dissolve do not take more than 6 caplets in 24 hours do not use for more than 10 days unless directed by a doctor under 18 years of age ask a doctor

Warnings

openFDA Drug Labeling

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 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.

Do Not Use

openFDA Drug Labeling

Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are allergic to acetaminophen or any of the inactive ingredients in this product

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use if you hav e liver disease

Stop Use

openFDA Drug Labeling

Stop use and ask a doctor if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present These could be signs of a serious condition.

Active Ingredient

openFDA Drug Labeling

Active ingredient (in each caplet) Acetaminophen 650 mg

Overdosage

openFDA Drug Labeling

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Adverse event reports

Source: openFDA FAERS

679,519

FAERS reports mentioning this drug

as of 2026-09-25T03:42:24+00:00

A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: ACETAMINOPHEN. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory

Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC	Product NDC	Labeler	Description	Marketing start
51316-969-01	51316-969	CVS Pharmacy	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (51316-969-01)	July 1, 2025
70000-0733-1	70000-0733	LEADER/ Cardinal Health 110, Inc.	1 BOTTLE in 1 CARTON (70000-0733-1) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE	June 15, 2025
70000-0733-2	70000-0733	LEADER/ Cardinal Health 110, Inc.	1 BOTTLE in 1 CARTON (70000-0733-2) / 50 TABLET, EXTENDED RELEASE in 1 BOTTLE	June 21, 2025
0904-7561-60	0904-7561	Major Pharmaceuticals	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0904-7561-60)	May 6, 2025
51316-969	51316-969	CVS Pharmacy	—	July 1, 2025
70000-0733	70000-0733	LEADER/ Cardinal Health 110, Inc.	—	June 15, 2025
0904-7561	0904-7561	Major Pharmaceuticals	—	May 6, 2025

Sources for this page

Every dataset that contributed a fact to this page.
Dataset	Agency	Used for
NDC Directory	FDA	Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA	FDA	Application, sponsor, submissions, review documents, marketing status
Drug Labeling	FDA / NLM	Prescribing information reproduced above
FAERS	FDA	Adverse event report counts

Generated September 25, 2026 · 9 sections on this page.