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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 formStrengthRouteNDCs
Tablet, coated220 mgoral4
Tablet, film coated220 mgoral2

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

All drug recalls

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