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Naproxen Sodium
Overview
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Naproxen Sodium | 220 mg/1 | 849431 | View |
Forms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Anti-Inflammatory Agents | EPC | All 251 members |
| Cyclooxygenase Inhibitors [MoA] | MoA | All 251 members |
| Non-Steroidal [CS] | CS | All 251 members |
| Nonsteroidal Anti-inflammatory Drug [EPC] | EPC | All 251 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 202807-001 | NAPROXEN SODIUM | CAPSULE | NAPROXEN SODIUM | Over-the-counter | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 8 | Labeling | Approved | September 19, 2023 | Standard |
| Supplement | 7 | Labeling | Approved | September 19, 2023 | Standard |
| Supplement | 3 | Labeling | Approved | April 9, 2020 | Standard |
| Supplement | 2 | Labeling | Approved | April 9, 2020 | Standard |
| Original application | 1 | Approved | January 4, 2019 | — |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20251117). 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: headache muscular aches minor pain of arthritis toothache backache the common cold menstrual cramps temporarily reduces fever
Purpose
openFDA Drug LabelingPurposes Pain reliever/fever reducer
Dosage and Administration
openFDA Drug LabelingDirections do not take more than directed the smallest effective dose should be used drink a full glass of water with each dose if taken with food, this product may taken longer to work adults and children 12 years and older: take 1 capsule every 8 to 12 hours while symptoms last for the first dose you may take 2 tablets within the first hour do not exceed 2 tablets in any 8- to 12-hour period do not exceed 3 tablets in a 24-hour period children under 12 years: ask a doctor
Warnings
openFDA Drug LabelingWarnings Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug have 3 or more alcoholic drinks every day while using this product take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) take more or for a longer time 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 if you use more than directed or for longer than directed Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery Ask a doctor before use if the stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke you have problems or serious side effects from taking pain relievers or fever reducers you are taking a diuretic Ask a doctor or pharmacist before use if you are under a doctor’s care for any serious condition taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin taking any other drug When using this product take with food or milk if stomach upset occurs Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better you have symptoms of heart problem or stroke: chest pain slurred speech leg swelling trouble breathing weakness in one part or side of the body pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear you have difficulty swallowing it feels like the pill is stuck in your throat If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Do Not Use
openFDA Drug LabelingDo not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery
Ask a Doctor
openFDA Drug LabelingAsk a doctor before use if the stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke you have problems or serious side effects from taking pain relievers or fever reducers you are taking a diuretic
Stop Use
openFDA Drug LabelingStop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better you have symptoms of heart problem or stroke: chest pain slurred speech leg swelling trouble breathing weakness in one part or side of the body pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear you have difficulty swallowing it feels like the pill is stuck in your throat
Active Ingredient
openFDA Drug LabelingActive ingredient (in each capsule) Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: NAPROXEN SODIUM. 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 |
|---|---|---|---|---|
| 49588-0003-1 | 49588-0003 | Catalent Argentina S.A.I.y C. | 1 BAG in 1 BOX (49588-0003-1) / 6000 CAPSULE in 1 BAG | February 28, 2020 |
| 59726-751-20 | 59726-751 | P & L Development, LLC | 1 BOTTLE, PLASTIC in 1 BOX (59726-751-20) / 20 CAPSULE in 1 BOTTLE, PLASTIC | December 4, 2020 |
| 10888-8115-1 | 10888-8115 | Patheon Softgels Inc. | 6000 CAPSULE in 1 BOX (10888-8115-1) | January 1, 2018 |
| 10888-8129-1 | 10888-8129 | Patheon Softgels Inc. | 6000 CAPSULE in 1 BOX (10888-8129-1) | November 6, 2014 |
| 10888-8130-1 | 10888-8130 | Patheon Softgels Inc. | 6000 CAPSULE in 1 BOX (10888-8130-1) | June 3, 2010 |
| 49588-0003 | 49588-0003 | Catalent Argentina S.A.I.y C. | — | February 28, 2020 |
| 59726-751 | 59726-751 | P & L Development, LLC | — | December 4, 2020 |
| 10888-8115 | 10888-8115 | Patheon Softgels Inc. | — | February 17, 2006 |
| 10888-8129 | 10888-8129 | Patheon Softgels Inc. | — | February 17, 2006 |
| 10888-8130 | 10888-8130 | Patheon Softgels Inc. | — | February 17, 2006 |
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 · 11 sections on this page.