Drugplain

Arthritis Pain 650 mg/1

Acetaminophen · TABLET, EXTENDED RELEASE · AMERIFOODS TRADING COMPANY

5 Recalls on RecordCurrently in Shortage
Plain English

Arthritis Pain is a tablet, extended release containing acetaminophen at 650 mg/1, taken oral. Manufactured by AMERIFOODS TRADING COMPANY.

Key Facts

Brand Name
Arthritis Pain
Generic Name
Acetaminophen
NDC Code (Product)
61504-200
Manufacturer
AMERIFOODS TRADING COMPANY
Strength
650 mg/1
Dosage Form
TABLET, EXTENDED RELEASE
Route
ORAL
Marketing Status
Application #
ANDA211544
Marketing Start
11/20/2025

Recall History

5 Recalls on Record
Class II08/31/2018

Beaumont Bio-med, Inc.

CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.

TerminatedVoluntary: Firm initiated
Class II06/23/2022

Family Dollar Stores, Llc.

CGMP Deviations: product held outside appropriate storage temperature conditions.

OngoingVoluntary: Firm initiated
Class II06/23/2022

Family Dollar Stores, Llc.

CGMP Deviations: product held outside appropriate storage temperature conditions.

OngoingVoluntary: Firm initiated
Class I07/20/2018

King Bio Inc.

Microbial contamination

TerminatedVoluntary: Firm initiated
Class I07/20/2018

King Bio Inc.

Microbial contamination

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective39,266 reports
off label use29,360 reports
fatigue25,619 reports
pain24,331 reports
nausea21,280 reports
headache19,881 reports
arthralgia17,987 reports
dyspnoea17,259 reports
vomiting16,672 reports
rash16,428 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses • for the temporary relief of arthritis pain ONLY in the following areas: • hand, wrist, elbow (upper body areas) • foot, ankle, knee (lower body areas) • this product may take up to 7 days to work for arthritis pain; it is not for immediate relief. If no pain relief in 7 days, stop use.

Dosage & Administration

Directions Use up to 21 days unless directed by your doctor Not for strains, sprains, bruises or sports injuries. This product has not been shown to work for these types of injuries. Daily Per Dose For your arthritis pain: • Use 4 times per day every day • Do not use on more than 2 body areas at the same time Use ENCLOSED DOSING CARD to measure a dose • For each upper body area (hand, wrist, or elbow) – Squeeze out 2.25 inches (2 grams) • For each lower body area (foot, ankle or knee) – Squeeze out 4.5 inches (4 grams) Read the enclosed User Guide for complete instructions: • use only as directed • do not use more than directed or for longer than directed • apply only to clean, dry skin that does not have any cuts, open wounds, infections or rashes • do not apply in the same area as any other product • do not apply with external heat such as heating pad • do not apply a bandage over the treated area • store ENCLOSED DOSING CARD with your Diclofenac Sodium Topical Gel, 1% product. The dosing card is re-usable.

Warnings

Warnings For external use only Allergy alert: Diclofenac may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: • hives • asthma (wheezing) • skin reddening • blisters • facial swelling • shock • rash If an allergic reaction occurs, stop use and seek medical help right away. Liver warning: This product contains diclofenac. Liver damage may occur if you apply • more or for a longer time than directed • when using other drugs containing diclofenac Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is small but higher if you • are age 60 or older • have had stomach ulcers or bleeding problems • take a blood thinning (anticoagulant) or steroid drug • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) • have 3 or more alcoholic drinks every day while using this product • apply more or for longer than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher is you use more than directed or for longer than directed. Do

Frequently Asked Questions

What is Arthritis Pain used for?

Arthritis Pain contains Acetaminophen. It is a tablet, extended release taken oral. Consult your doctor for specific uses.

Is Arthritis Pain a controlled substance?

Arthritis Pain is not classified as a controlled substance by the DEA.

What is the generic name for Arthritis Pain?

The generic name for Arthritis Pain is Acetaminophen. There are 12 other brand versions of Acetaminophen.

What is the NDC code for Arthritis Pain 650 mg/1?

The NDC (National Drug Code) for Arthritis Pain 650 mg/1 is 61504-200, listed by AMERIFOODS TRADING COMPANY.