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Arthritis Pain Relief

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
Arthritis Pain Relief
Generic name
Acetaminophen
Dosage form
Tablet, Extended Release
Route
Oral
Marketing category
ANDA · ANDA
Labeler
KROGER COMPANY
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
5
Packages
10
Data completeness
82% 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
15

Regulatory status

Source: Drugs@FDANDC Directory
Application number
211544
Application type
ANDA · Abbreviated New Drug Application
Approval date
April 16, 2019
Sponsor
GRANULES
Products on application
1
Submissions recorded
2
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 20250510). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20250510 HUMAN OTC DRUG · 20221004

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 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 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 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 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
68016-303-01 68016-303 CHAIN DRUG CONSORTIUM 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (68016-303-01) August 1, 2020
41226-699-01 41226-699 KROGER COMPANY 1 BOTTLE in 1 CARTON (41226-699-01) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE April 15, 2024
41226-699-26 41226-699 KROGER COMPANY 225 TABLET, EXTENDED RELEASE in 1 BOTTLE (41226-699-26) June 5, 2025
41226-699-42 41226-699 KROGER COMPANY 1 BOTTLE in 1 CARTON (41226-699-42) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE June 5, 2025
41250-658-03 41250-658 Meijer 1 BOTTLE, PLASTIC in 1 CARTON (41250-658-03) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC March 6, 2020
36800-632-01 36800-632 TOPCO ASSOCIATES LLC 1 BOTTLE, PLASTIC in 1 CARTON (36800-632-01) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC October 4, 2022
36800-632-02 36800-632 TOPCO ASSOCIATES LLC 1 BOTTLE, PLASTIC in 1 CARTON (36800-632-02) / 50 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC October 4, 2022
36800-632-03 36800-632 TOPCO ASSOCIATES LLC 1 BOTTLE, PLASTIC in 1 CARTON (36800-632-03) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC October 4, 2022
36800-632-05 36800-632 TOPCO ASSOCIATES LLC 150 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (36800-632-05) October 4, 2022
67091-401-02 67091-401 WINCO FOODS, LLC 2 BOTTLE, PLASTIC in 1 CARTON (67091-401-02) / 50 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC April 11, 2023
68016-303 68016-303 CHAIN DRUG CONSORTIUM — August 1, 2020
41226-699 41226-699 KROGER COMPANY — April 15, 2024
41250-658 41250-658 Meijer — March 6, 2020
36800-632 36800-632 TOPCO ASSOCIATES LLC — October 4, 2022
67091-401 67091-401 WINCO FOODS, LLC — April 11, 2023

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 · 10 sections on this page.