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← See all Naproxen Sodium brands

Naproxen Sodium by Polygen Pharmaceuticals LLC

Dosage form: tablet, coated
Ingredients: NAPROXEN SODIUM 220mg
Labeler: Polygen Pharmaceuticals LLC
NDC Code: 52605-141

Naproxen Sodium Tablets, USP 220 mg

Active ingredient(s)

 Naproxen Sodium 220 mg (naproxen 200 mg) (NSAID)*

 *nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/Fever reducer 


Use(s)

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
  • 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

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, or kidney disease
  • you are taking a diuretic
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • you have asthma

Ask a doctor or pharmacist before use if
  • under a doctor's care for any serious condition
  • taking any other drug

When using this product
  • take with food or milk if stomach upset occurs
  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

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
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present in the painful area
  • any new symptoms appear
  • you have difficulty swallowing
  • it feels like the pill is stuck in your throat

Pregnancy/Breastfeeding

ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of 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
  • 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

Storage

store at 20-25°C (68-77°F) avoid high humidity and excessive heat above 40°C (104°F).

Other information
  • each tablet contains: sodium 20 mg
  • side effects occur. You may report side effects to PolyGen at 1-888-291-7337 and/ or FDA at 1-800-FDA-1088.

Inactive ingredients

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

 

Questions or comments

1-800-291-7337


Principal Display Panel


NAPROXEN SODIUM TABLETS:
 

Carton PDP:

NDC: 52605-141-01

Compare to the active ingredient in Aleve®

ALL DAY PAIN RELIEF

NAPROXEN SODIUM TABLETS, USP 220 mg

PAIN RELIEVER/ FEVER REDUCER (NSAID)

 

STRENGTH TO LAST 12 HOURS

100 TABLETS




Bottle Label PDP:

NDC: 52605-141-01

ALL DAY PAIN RELIEF

NAPROXEN SODIUM TABLETS, USP 220 mg

PAIN RELIEVER/ FEVER REDUCER(NSAID)

 

STRENGTH TO LAST 12 HOURS

100 TABLETS




NAPROXEN SODIUM CAPLETS:
 

Carton PDP:
 
NDC: 52605-144-01
 
Compare to the active ingredient in Aleve®
 
ALL DAY PAIN RELIEF
NAPROXEN SODIUM TABLETS, USP 220 mg
PAIN RELIEVER/ FEVER REDUCER (NSAID)
 
STRENGTH TO LAST 12 HOURS
 
100 CAPLETS (CAPSULE- SHAPED TABLETS)
 

 

Bottle Label PDP:
 
NDC: 52605-144-01
 
 
ALL DAY PAIN RELIEF
NAPROXEN SODIUM TABLETS, USP 220 mg
PAIN RELIEVER/ FEVER REDUCER (NSAID)
 
STRENGTH TO LAST 12 HOURS
 
100 CAPLETS (CAPSULE- SHAPED TABLETS)
 
 




NAPROXEN SODIUM CAPLETS:
 

Carton PDP:
 
NDC: 52605-144-24
 
Compare to the active ingredient in Aleve®
 
ALL DAY PAIN RELIEF
NAPROXEN SODIUM TABLETS, USP 220 mg
PAIN RELIEVER/ FEVER REDUCER (NSAID)
 
STRENGTH TO LAST 12 HOURS
 
24 CAPLETS (CAPSULE- SHAPED TABLETS)



 


Bottle Label PDP:
 
NDC: 52605-144-24
 
 
ALL DAY PAIN RELIEF
NAPROXEN SODIUM TABLETS, USP 220 mg
PAIN RELIEVER/ FEVER REDUCER (NSAID)
 
STRENGTH TO LAST 12 HOURS
 
24 CAPLETS (CAPSULE- SHAPED TABLETS)








NAPROXEN SODIUM 
naproxen sodium tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52605-141
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPROXEN SODIUM (NAPROXEN) NAPROXEN SODIUM220 mg
Inactive Ingredients
Ingredient NameStrength
COLLOIDAL SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
FD&C BLUE NO. 2 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POVIDONE 
TITANIUM DIOXIDE 
POLYETHYLENE GLYCOLS 
Product Characteristics
ColorBLUEScoreno score
ShapeROUNDSize10mm
FlavorImprint Code141
Contains    
Packaging
#Item CodePackage Description
1NDC:52605-141-011 BOTTLE in 1 CARTON
1100 TABLET, COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09054506/11/2012
NAPROXEN SODIUM 
naproxen sodium tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52605-144
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPROXEN SODIUM (NAPROXEN) NAPROXEN SODIUM220 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
COLLOIDAL SILICON DIOXIDE 
FD&C BLUE NO. 2 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POVIDONE 
TITANIUM DIOXIDE 
POLYETHYLENE GLYCOLS 
Product Characteristics
ColorBLUEScoreno score
ShapeOVALSize12mm
FlavorImprint Code144
Contains    
Packaging
#Item CodePackage Description
1NDC:52605-144-011 BOTTLE in 1 CARTON
1100 TABLET, COATED in 1 BOTTLE
2NDC:52605-144-241 BOTTLE in 1 CARTON
224 TABLET, COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09054511/13/2012
Labeler - Polygen Pharmaceuticals LLC (962415720)
Registrant - Polygen Pharmaceuticals LLC (962415720)
Establishment
NameAddressID/FEIOperations
Marksans Pharma Limited925822975MANUFACTURE(52605-144)

 
Polygen Pharmaceuticals LLC

← See all Naproxen Sodium brands

Medically reviewed on Jun 25, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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