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arthritis pain relief
Acetaminophen · Tablet, Film Coated, Extended Release
Overview
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Acetaminophen | 650 mg/1 | 313782 | View |
Forms, strengths and routes
Source: NDC DirectoryRegulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 075077-001 | ACETAMINOPHEN | TABLET, EXTENDED RELEASE | ACETAMINOPHEN | Over-the-counter | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 55 | Labeling | Approved | August 16, 2019 | Standard |
| Supplement | 40 | Labeling | Approved | January 10, 2016 | Standard |
| Supplement | 32 | Labeling | Approved | November 30, 2013 | — |
| Supplement | 28 | Labeling | Approved | October 25, 2010 | — |
| Supplement | 6 | Labeling | Approved | February 10, 2005 | — |
| Supplement | 1 | Labeling | Approved | December 29, 2000 | — |
| Original application | 1 | Approved | February 25, 2000 | — |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20221027). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingUses • 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 LabelingPurpose Pain reliever/fever reducer
Dosage and Administration
openFDA Drug LabelingDirections • 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 • do not use for more than 10 days unless directed by a doctor under 18 years of age • ask a doctor
Warnings
openFDA Drug LabelingWarnings 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 LabelingDo 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 LabelingAsk a doctor before use if you have liver disease
Stop Use
openFDA Drug LabelingStop 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 LabelingActive ingredient (in each caplet) Acetaminophen 650 mg
Adverse event reports
Source: openFDA FAERSAttributed 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| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 41250-966-47 | 41250-966 | Meijer Distribution Inc | 150 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (41250-966-47) | September 5, 2007 |
| 56062-544-62 | 56062-544 | Publix Super Markets Inc | 1 BOTTLE in 1 CARTON (56062-544-62) / 24 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE | November 26, 2007 |
| 56062-544-78 | 56062-544 | Publix Super Markets Inc | 1 BOTTLE in 1 CARTON (56062-544-78) / 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE | November 28, 2007 |
| 41250-966 | 41250-966 | Meijer Distribution Inc | — | September 5, 2007 |
| 56062-544 | 56062-544 | Publix Super Markets Inc | — | November 26, 2007 |
Sources for 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.