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Naproxen Sodium HEADACHE PAIN
Naproxen Sodium · Tablet, Film Coated
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 |
|---|---|---|---|---|---|---|---|
| 205497-001 | NAPROXEN SODIUM | TABLET | NAPROXEN SODIUM | Over-the-counter | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Original application | 1 | Approved | March 18, 2016 | Standard |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20250523). 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 minor pain of arthritis muscular aches backache menstrual cramps toothache the common cold 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 Adults and children 12 years and older take 1 tablet 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 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 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
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 are taking a diuretic you have problems or serious side effects from taking pain relievers or fever reducers
Stop Use
openFDA Drug LabelingStop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better you have symptoms of heart problems or stroke: chest pain trouble breathing weakness in one part or side of body slurred speech leg swelling pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days you have difficulty swallowing it feels like the pill is stuck in your throat redness or swelling is present in the painful area any new symptoms appear
Active Ingredient
openFDA Drug LabelingActive ingredient (in each tablet) Naproxen sodium USP 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 |
|---|---|---|---|---|
| 58602-735-07 | 58602-735 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-735-07) / 24 TABLET, FILM COATED in 1 BOTTLE | July 14, 2021 |
| 58602-735-19 | 58602-735 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-735-19) / 90 TABLET, FILM COATED in 1 BOTTLE | September 21, 2023 |
| 58602-735-21 | 58602-735 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-735-21) / 100 TABLET, FILM COATED in 1 BOTTLE | July 14, 2021 |
| 58602-735-29 | 58602-735 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-735-29) / 150 TABLET, FILM COATED in 1 BOTTLE | July 14, 2021 |
| 58602-735-38 | 58602-735 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-735-38) / 300 TABLET, FILM COATED in 1 BOTTLE | July 14, 2021 |
| 58602-735-40 | 58602-735 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-735-40) / 500 TABLET, FILM COATED in 1 BOTTLE | July 14, 2021 |
| 58602-735-78 | 58602-735 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-735-78) / 50 TABLET, FILM COATED in 1 BOTTLE | July 14, 2021 |
| 58602-737-07 | 58602-737 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-737-07) / 24 TABLET, FILM COATED in 1 BOTTLE | July 14, 2021 |
| 58602-737-12 | 58602-737 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-737-12) / 40 TABLET, FILM COATED in 1 BOTTLE | July 14, 2021 |
| 58602-737-19 | 58602-737 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-737-19) / 90 TABLET, FILM COATED in 1 BOTTLE | August 2, 2024 |
| 58602-737-21 | 58602-737 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-737-21) / 100 TABLET, FILM COATED in 1 BOTTLE | July 14, 2021 |
| 58602-737-25 | 58602-737 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-737-25) / 130 TABLET, FILM COATED in 1 BOTTLE | July 14, 2021 |
| 58602-737-29 | 58602-737 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-737-29) / 150 TABLET, FILM COATED in 1 BOTTLE | July 14, 2021 |
| 58602-737-34 | 58602-737 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-737-34) / 200 TABLET, FILM COATED in 1 BOTTLE | July 14, 2021 |
| 58602-737-38 | 58602-737 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-737-38) / 300 TABLET, FILM COATED in 1 BOTTLE | July 14, 2021 |
| 58602-737-40 | 58602-737 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-737-40) / 500 TABLET, FILM COATED in 1 BOTTLE | July 14, 2021 |
| 58602-737-44 | 58602-737 | Aurohealth LLC | 400 TABLET, FILM COATED in 1 BOTTLE (58602-737-44) | July 14, 2021 |
| 58602-737-78 | 58602-737 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-737-78) / 50 TABLET, FILM COATED in 1 BOTTLE | July 14, 2021 |
| 58602-735 | 58602-735 | Aurohealth LLC | — | July 14, 2021 |
| 58602-737 | 58602-737 | Aurohealth LLC | — | July 14, 2021 |
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.