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Naproxen Sodium (naproxen sodium 220 mg) Dailymed

  1. Human OTC
  2. Nonsteroidal Anti-inflammatory Drug
  3. MARKSANS PHARMA LIMITED

Generic: naproxen sodium, coated tablets is used for the treatment of Arthritis, Juvenile Arthritis, Rheumatoid Back Pain Bursitis Common Cold Dysmenorrhea Fever Gout Headache Inflammation Osteoarthritis Pain Pregnancy Trimester, Third Spondylitis, Ankylosing Toothache

Naproxen Sodium tablet - (naproxen sodium 220 mg) image

IMPRINT: 144     SHAPE: oval
    COLOR: blue

  1. FDA Adverse Reactions

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Active Ingredient(s)


For Tablets: Active ingredient (in each tablet) Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug

 

For Caplets: Active ingredient (in each caplet) 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: 

 • minor pain of arthritis • muscular aches • backache • menstrual cramps • headache • toothache • the common cold temporarily reduces fever

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 • bulers 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 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 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)

Directions


For Tablets:

• 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

For Caplets:

• 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 caplet every 8 to 12 hours while symptoms last • for the first dose you may take 2 caplets within the first hour • do not exceed 2 caplets in any 8- to 12-hour period • do not exceed 3 caplets in a 24-hour period
 Children under 12 years • ask a doctor

Other Information


For Tablets:

• each tablet contains: sodium 20 mg • store at 20-25ºC (68-77ºF). • avoid high humidity and excessive heat above 40°C (104°F).  

For Caplets:

• each caplet contains: sodium 20 mg • store at 20-25ºC (68-77ºF). • avoid high humidity and excessive heat above 40°C (104°F).  

Inactive Ingredients


colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2 Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide  

 

Questions Or Comments?


call toll free 1-877-376-4271

 

Manufactured for:

Time-Cap Labs, Inc.

7 Michael Avenue, Farmingdale,

NY 11735, USA

Manufactured by:

Marksans Pharma Ltd.

Plot No. L-82, L-83,

Verna Indl. Estate,

Verna, Goa - 403722, India.

Mfg. Lic. No.: GO/DRUGS/515

Principal Display Panel


NDC 25000-141-43 Naproxen Sodium Tablets, USP 220 mg 10’s count bottle label

NDC 25000-141-43 Naproxen Sodium Tablets, USP 220 mg 10’s count carton label NDC 25000-141-02 Naproxen Sodium Tablets, USP 220 mg 24’s count bottle label  

NDC 25000-141-02 Naproxen Sodium Tablets, USP 220 mg 24’s count carton label



NDC 25000-141-14 Naproxen Sodium Tablets, USP 220 mg 1000’s count bottle label  

NDC 25000-144-14 Naproxen Sodium Tablets, USP 220 mg (Capsule-shaped tablet)1000’s count bottle label

NDC 25000-144-43 Naproxen Sodium Tablets, USP 220 mg (Capsule-shaped tablet) 10’s count bottle label

  NDC 25000-144-43 Naproxen Sodium Tablets, USP 220 mg (Capsule-shaped tablet) 10’s count carton label

NDC 25000-144-02 Naproxen Sodium Tablets, USP 220 mg (Capsule-shaped tablet)24’s count bottle label  

NDC 25000-144-02 Naproxen Sodium Tablets, USP 220 mg (Capsule-shaped tablet)24’s count carton label

 

DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

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"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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