Back and Muscle Pain

Back and Muscle Pain is an FDA-registered drug product whose active ingredient is NAPROXEN SODIUM. It is labelled by CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 51316-817, application ANDA204872, label effective 20260713. It is one of 81 FDA drug label records sharing the active ingredient NAPROXEN SODIUM. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing NAPROXEN SODIUM are most often described in connection with: temporarily relieves, minor aches, pains due, backache muscular, common cold, toothache headache, menstrual cramps, pain arthritis. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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.

FDA lists 81 drug label records with NAPROXEN SODIUM as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is Back and Muscle Pain used for?
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

Who makes Back and Muscle Pain?
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED is the labeler of record for Back and Muscle Pain. 81 FDA label records share the active ingredient NAPROXEN SODIUM, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Back and Muscle Pain come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Back and Muscle Pain prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing NAPROXEN SODIUM?
Yes. 81 FDA drug label records list NAPROXEN SODIUM as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Back and Muscle Pain been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.