Arthritis Pain

ACETAMINOPHEN ORAL HUMAN OTC DRUG

Arthritis Pain is an FDA drug label for the active ingredient ACETAMINOPHEN manufactured by Grocery Outlet, Inc. administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260521.

Generic name
ACETAMINOPHEN
Manufacturer
Grocery Outlet, Inc.
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
85828-200
Application
ANDA211544
Label effective
20260521

About this product

Arthritis Pain is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN. It is labelled by Grocery Outlet, Inc. taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 85828-200, application ANDA211544, label effective 20260521. It is one of 274 FDA drug label records sharing the active ingredient ACETAMINOPHEN. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

What it is used for

Across FDA labelling, products containing ACETAMINOPHEN are most often described in connection with: temporarily relieves, minor aches, pains due, pain arthritis, backache premenstrual, menstrual cramps, common cold, headache toothache. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active ingredient (in each caplet) Acetaminophen 650 mg

Indications & Usage

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

Dosage & Administration

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

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.

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How products containing ACETAMINOPHEN compare

FDA lists 274 drug label records with ACETAMINOPHEN as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

Dosage formProductsManufacturerProducts
— — Aurohealth LLC 21
— — Genexa Inc. 10
— — Kenvue Brands LLC 9
— — CVS PHARMACY 8
— — Rite Aid Corporation 7

Recall and safety notices

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

RecallProductFirmClassStatusReported
D-1434-2022 VOLTAREN ARTHRITIS PAIN GEL 20G distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. Family Dollar Stores, Llc. Class II Ongoing 20220831
D-1388-2022 BC ARTHRITIS PAIN FAST PAIN RELIEF 24CT SKU 999839 GOOD SENSE ARTHRITIS CAPLET 24 CT SKU 914771 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. Family Dollar Stores, Llc. Class II Ongoing 20220831
D-0961-2019 Dr. King's Arthritis Pain & Joint Relief Soulagement De La Douleur Arthritique et Articulaire, 59 mL, (liquid/liquid) DIN-HM 80035118 UPC 357955180425 King Bio Inc. Class I Terminated 20190320
D-0559-2019 Dr. King's Natural Medicine Homeopathic Arthritis Pain & Joint Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955516224, NDC 57955-6162-2 King Bio Inc. Class I Terminated 20190320
D-1199-2018 Arthritis Pain Relief Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7042-7 Beaumont Bio-med, Inc. Class II Terminated 20180926

Frequently asked questions

What is Arthritis Pain used for?
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

Who makes Arthritis Pain?
Grocery Outlet, Inc. is the labeler of record for Arthritis Pain. 274 FDA label records share the active ingredient ACETAMINOPHEN, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Arthritis Pain come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Arthritis Pain prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing ACETAMINOPHEN?
Yes. 274 FDA drug label records list ACETAMINOPHEN as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Arthritis Pain been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.

This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.