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8 Hour Arthritis Pain

Acetaminophen · Tablet, Extended Release

Over-the-counter ANDA Official labelling

Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name

8 Hour Arthritis Pain

Generic name

Acetaminophen

Dosage form

Tablet, Extended Release

Route

Oral

Marketing category

ANDA · ANDA

Labeler

AMERISOURCE BERGEN

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

NDC product codes

Packages

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

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

211544

Application type

ANDA · Abbreviated New Drug Application

Approval date

April 16, 2019

Sponsor

GRANULES

Products on application

Submissions recorded

Products approved under application 211544.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
211544-001	ACETAMINOPHEN	TABLET, EXTENDED RELEASE		ACETAMINOPHEN	Over-the-counter	—

Approval history

Source: Drugs@FDA

Most recent submissions on application 211544.
Type	No.	Action	Status	Date	Review
Supplement	16	Labeling	Approved	January 18, 2024	Standard
Original application	1		Approved	April 16, 2019	Standard

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20251211). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20251211

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, unless directed by a doctor 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 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 before use if you have liver disease Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin 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. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. 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.

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 have 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

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
46122-629-62	46122-629	AMERISOURCE BERGEN	1 BOTTLE, PLASTIC in 1 CARTON (46122-629-62) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC	January 30, 2023
46122-629-71	46122-629	AMERISOURCE BERGEN	1 BOTTLE, PLASTIC in 1 CARTON (46122-629-71) / 50 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC	January 13, 2020
46122-629-78	46122-629	AMERISOURCE BERGEN	1 BOTTLE, PLASTIC in 1 CARTON (46122-629-78) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC	January 13, 2020
46122-629-81	46122-629	AMERISOURCE BERGEN	200 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (46122-629-81)	January 13, 2020
83324-083-01	83324-083	CHAIN DRUG MARKETING ASSOCIATION, INC.	100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (83324-083-01)	May 1, 2024
83324-083-50	83324-083	CHAIN DRUG MARKETING ASSOCIATION, INC.	1 BOTTLE, PLASTIC in 1 CARTON (83324-083-50) / 50 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC	May 1, 2024
68998-401-03	68998-401	MARC GLASSMAN, INC.	1 BOTTLE, PLASTIC in 1 CARTON (68998-401-03) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC	October 5, 2022
63941-300-02	63941-300	VALU MERCHANDISERS COMPANY	1 BOTTLE, PLASTIC in 1 CARTON (63941-300-02) / 50 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC	January 1, 2020
63941-300-04	63941-300	VALU MERCHANDISERS COMPANY	100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63941-300-04)	January 1, 2020
46122-629	46122-629	AMERISOURCE BERGEN	—	January 13, 2020
83324-083	83324-083	CHAIN DRUG MARKETING ASSOCIATION, INC.	—	May 1, 2024
68998-401	68998-401	MARC GLASSMAN, INC.	—	October 5, 2022
63941-300	63941-300	VALU MERCHANDISERS COMPANY	—	January 1, 2020

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.