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Naproxen Sodium Headache Pain
naproxen sodium · Naproxen Sodium Headache Pain is an over-the-counter drug containing naproxen sodium, made by 2 manufacturers.
- Type
- Over the counter
- Drug class
- Not classified
- Route
- Oral
- Manufacturers
- 2
temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache menstrual cramps headache toothache the common cold temporarily reduces fever
Drug facts
- Generic name
- naproxen sodium
- Active ingredients
- Naproxen Sodium
- Dosage forms
- Tablet, coated, Tablet, film coated
- Label holder
- Dr.Reddy's Laboratories Inc
- FDA application
- ANDA075168
- Label updated
- 06/03/2025
Active ingredients
(in each tablet/caplet) Naproxen sodium USP, 220 mg (naproxen USP, 200 mg) (NSAID) nonsteroidal anti-inflammatory drug
Purpose
Pain reliever/fever reducer
Uses
Temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache menstrual cramps headache toothache the common cold temporarily reduces fever
Directions
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/caplet every 8 to 12 hours while symptoms last for the first dose you may take 2 tablets/caplets within the first hour do not exceed 2 tablets/caplets in any 8 to 12 hour period do not exceed 3 tablets/caplets in a 24-hour period Children under 12 years ask a doctor
Warnings
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 everyday 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 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 are taking a diuretic you have problems or serious side effects from taking pain relievers or fever reducers 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 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 If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium at 20 weeks or later in 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 right away (1-800-222-1222).
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 are taking a diuretic you have problems or serious side effects from taking pain relievers or fever reducers
Ask a doctor or pharmacist before use
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
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
Pregnancy or breastfeeding
Ask a health professional before use. It is especially important not to use naproxen sodium at 20 weeks or later in 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 right away (1-800-222-1222).
Other information
Each tablet/caplet contains: sodium 20 mg store at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F).
Inactive ingredients
FD &C Blue # 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, talc, titanium dioxide
Questions?
Call toll-free weekdays 9 AM to 8 PM EST at 1-888-375-3784
Forms and strengths
From the FDA NDC Directory · 6 product codes
| Dosage form | Strength | Route | NDCs |
|---|---|---|---|
| Tablet, coated | 220 mg | oral | 4 |
| Tablet, film coated | 220 mg | oral | 2 |
Side effect reports to FDA
FDA Adverse Event Reporting System (FAERS), 142,041 reports that list naproxen sodium, data through 07/30/2026
Anyone can report a problem to FDA, and a report does not mean the drug caused the problem. Reports can be duplicated or incomplete, and counts depend on how widely a drug is used. Do not stop or change a medicine because of this list. Talk to your doctor or pharmacist.
Most often reported reactions
- Drug ineffective20,260
- Pain12,513
- Fatigue11,625
- Nausea10,786
- Arthralgia10,556
- Headache9,278
- Off label use8,974
- Diarrhea8,575
- Dizziness8,000
- Vomiting7,527
To report a side effect, use FDA MedWatch.
Manufacturers and labels
3 FDA labels
- Dr.Reddy's Laboratories IncShown hereANDA075168 · Label 06/03/2025 · NDC 43598-071, 43598-072, 43598-073 +1Full label
- Aurohealth LLCANDA205497 · Label 05/26/2025 · NDC 58602-737Full label
- Aurohealth LLCANDA205497 · Label 05/23/2025 · NDC 58602-735Full label
Related recalls
FDA drug recalls that name this drug or its active ingredient
- Class IIDrugOngoing05/13/2026NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distributed by: Acella...Acella Pharmaceuticals, LLC · Chemical contamination; presence of lead and lithium above...
- Class IIDrugOngoing04/16/2025Naproxen Sodium Tablets, USP, 550mg, 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals...Glenmark Pharmaceuticals Inc., USA · CGMP Deviations
- Class IIDrugOngoing12/06/2023Naproxen Tablets, USP 250mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd....Glenmark Pharmaceuticals Inc., USA · Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
- Class IIDrug09/29/2021Naproxen Sodium Tablets, USP 275 mg 100 Tablets Rx Only NDC 68462-178-01 Manufactured by: Glenmark...Glenmark Pharmaceuticals Inc., USA · 2 products · CGMP Deviations
- Class IIDrug09/08/2021Naproxen Sodum Tablets USP 220 mg, (Caplet), Manufactured by: Granules India Limited, Sy.No. 160/A, 161/E...Granules USA, Inc. · CGMP Deviations
Naproxen Sodium Headache Pain: common questions
- What is Naproxen Sodium Headache Pain used for?
- temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache menstrual cramps headache toothache the common cold temporarily reduces fever
- Is Naproxen Sodium Headache Pain a prescription drug?
- No. Naproxen Sodium Headache Pain is sold over the counter (OTC) without a prescription.
- Are there other products with the same active ingredient as Naproxen Sodium Headache Pain?
- Yes. Other FDA-listed products with the same active ingredients include Naproxen Sodium, All Day Pain Relief, Naproxen, Naproxen Sodium 220mg.
- Who makes Naproxen Sodium Headache Pain?
- 2 manufacturers list Naproxen Sodium Headache Pain with the FDA, including Dr.Reddy's Laboratories Inc, Aurohealth LLC.
Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 06/03/2025 · Label text is shown as published by the manufacturer. Not medical advice