Your browser does not support JavaScript! NAPROXEN SODIUM TABLET, COATED [POLYGEN PHARMACEUTICALS LLC]
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RxNorm Names

NAPROXEN SODIUM tablet, coated
[Polygen Pharmaceuticals LLC]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL Abbreviated New Drug Application
Drug Label Sections

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



Naproxensodium

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



Naproxensodiumtablets

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)
 
Naproxensodium
 

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)
 
Naproxensodiumcaplets 




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)



 naproxensodium24


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)



naproxensodium24




NAPROXEN SODIUM 
naproxen sodium tablet, coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem 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 Code 141
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52605-141-011 in 1 CARTON
1100 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 DRUG LABELItem 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 Code 144
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52605-144-011 in 1 CARTON
1100 in 1 BOTTLE
2NDC:52605-144-241 in 1 CARTON
224 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/FEIBusiness Operations
Marksans Pharma Limited925822975MANUFACTURE(52605-144)

Revised: 6/2013
 
Polygen Pharmaceuticals LLC

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