Drugplain

Back and Muscle Pain 220 mg/1

Naproxen Sodium · TABLET, FILM COATED · CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED

No Recall History
Plain English

Back and Muscle Pain is a tablet, film coated containing naproxen sodium at 220 mg/1, taken oral. Manufactured by CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED.

Key Facts

Brand Name
Back and Muscle Pain
Generic Name
Naproxen Sodium
NDC Code (Product)
51316-817
Manufacturer
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Strength
220 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
ANDA204872
Marketing Start
04/18/2022

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective19,814 reports
pain12,252 reports
fatigue11,376 reports
nausea10,542 reports
arthralgia10,330 reports
headache9,067 reports
off label use8,702 reports
diarrhoea8,353 reports
dizziness7,819 reports
vomiting7,328 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

Dosage & Administration

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

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 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

Frequently Asked Questions

What is Back and Muscle Pain used for?

Back and Muscle Pain contains Naproxen Sodium. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is Back and Muscle Pain a controlled substance?

Back and Muscle Pain is not classified as a controlled substance by the DEA.

What is the generic name for Back and Muscle Pain?

The generic name for Back and Muscle Pain is Naproxen Sodium. There are 12 other brand versions of Naproxen Sodium.

What is the NDC code for Back and Muscle Pain 220 mg/1?

The NDC (National Drug Code) for Back and Muscle Pain 220 mg/1 is 51316-817, listed by CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED.