Acetaminophen Extended-Release Tablets, 650 mg — Tablet, Extended Release

Overview

Brand name

Acetaminophen Extended-Release Tablets, 650 mg

Generic name

Acetaminophen

Dosage form

Tablet, Extended Release

Route

Oral

Marketing category

ANDA · ANDA

Labeler

MARKSANS PHARMA LIMITED

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

1

NDC product codes

2

Packages

7

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

9

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 20231017). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20231017

Indications and Usage

openFDA Drug Labeling

Uses Acetaminophen Extended-Release Tablets USP, 650 mg - Arthritis Pain 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. Acetaminophen Extended-Release Tablets USP, 650 mg - Muscle Aches and Pain temporarily relieves minor aches and pains due to: muscular aches backache minor pain of arthritis toothache premenstrual and menstrual cramps headache the common cold 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 and children 12 years and over 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 children under 12 years ask a doctor. Other information store between 20-25°C (68-77°F) The FDA approved Dissolution methods differ from USP do not use if carton is opened. Do not use if foil inner seal is broken or missing

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 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
25000-071-02	25000-071	MARKSANS PHARMA LIMITED	1 BOTTLE in 1 CARTON (25000-071-02) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE	September 2, 2021
25000-071-08	25000-071	MARKSANS PHARMA LIMITED	1 BOTTLE in 1 CARTON (25000-071-08) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE	September 2, 2021
25000-071-10	25000-071	MARKSANS PHARMA LIMITED	1 BOTTLE in 1 CARTON (25000-071-10) / 225 TABLET, EXTENDED RELEASE in 1 BOTTLE	September 2, 2021
25000-071-11	25000-071	MARKSANS PHARMA LIMITED	1 BOTTLE in 1 CARTON (25000-071-11) / 290 TABLET, EXTENDED RELEASE in 1 BOTTLE	September 2, 2021
25000-071-45	25000-071	MARKSANS PHARMA LIMITED	400 TABLET, EXTENDED RELEASE in 1 BOTTLE (25000-071-45)	September 7, 2021
25000-108-02	25000-108	MARKSANS PHARMA LIMITED	1 BOTTLE in 1 CARTON (25000-108-02) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE	October 14, 2022
25000-108-08	25000-108	MARKSANS PHARMA LIMITED	1 BOTTLE in 1 CARTON (25000-108-08) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE	October 14, 2022
25000-071	25000-071	MARKSANS PHARMA LIMITED	—	September 2, 2021
25000-108	25000-108	MARKSANS PHARMA LIMITED	—	October 14, 2022

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.