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Back and Muscle Pain
naproxen sodium · Back and Muscle 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: backache muscular aches the common cold toothache headache menstrual cramps minor pain of arthritis temporarily reduces fever
Drug facts
- Generic name
- naproxen sodium
- Active ingredients
- Naproxen Sodium
- Dosage forms
- Tablet, film coated
- Label holder
- CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
- FDA application
- ANDA204872
- Label updated
- 07/13/2026
Active ingredients
(in each tablet) Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug
Purpose
Pain reliever/fever reducer
Uses
Temporarily relieves minor aches and pains due to: backache muscular aches the common cold toothache headache menstrual cramps minor pain of arthritis 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 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
Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: asthma (wheezing) skin reddening shock blisters rash facial swelling hives 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 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 are taking a diuretic 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 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: leg swelling chest pain slurred speech trouble breathing weakness in one part or side of body 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.
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 are taking a diuretic 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
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: leg swelling chest pain slurred speech trouble breathing weakness in one part or side of body 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.
Other information
Each tablet contains: sodium 20 mg store at 20°-25°C (68°-77°F). Avoid high humidity and excessive heat above 40°C (104°F) see end flap for expiration date and lot number
Inactive ingredients
Croscarmellose sodium, FD&C blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, talc, titanium dioxide
Questions?
Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday
Forms and strengths
From the FDA NDC Directory · 2 product codes
| Dosage form | Strength | Route | NDCs |
|---|---|---|---|
| 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
2 FDA labels
- CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDShown hereANDA204872 · Label 07/13/2026 · NDC 51316-817Full label
- Rite Aid CorporationANDA204872 · Label 02/11/2026 · NDC 11822-4170Full 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
Back and Muscle Pain: common questions
- What is Back and Muscle Pain used for?
- temporarily relieves minor aches and pains due to: backache muscular aches the common cold toothache headache menstrual cramps minor pain of arthritis temporarily reduces fever
- Is Back and Muscle Pain a prescription drug?
- No. Back and Muscle Pain is sold over the counter (OTC) without a prescription.
- Are there other products with the same active ingredient as Back and Muscle Pain?
- Yes. Other FDA-listed products with the same active ingredients include Naproxen Sodium, All Day Pain Relief, Naproxen, Naproxen Sodium 220mg.
- Who makes Back and Muscle Pain?
- 2 manufacturers list Back and Muscle Pain with the FDA, including CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED, Rite Aid Corporation.
Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 07/13/2026 · Label text is shown as published by the manufacturer. Not medical advice