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NAPROXEN SODIUM by SPIRIT PHARMACEUTICALS,LLC

Dosage form: tablet, film coated, extended release
Ingredients: NAPROXEN SODIUM 220mg
Labeler: SPIRIT PHARMACEUTICALS,LLC
NDC Code: 68210-0400

NAPROXEN SODIUM TABLETS, USP 220 mg

Drug Facts

Active ingredients (in each tablet)Purpose
Nonsteroidal anti-inflammatory drug
Naproxen Sodium 220 mgPain reliever
(Naproxen Sodium 200mg) (NSAID) Fever reducer

Uses
  • temporarily relieves minor aches and pain due to :
    • backache
    • headache
    • menstrul cramps
    • minor pain of arthritis
    • muscular aches
    • the common cold
    • toothache
  • temporarily reduces fever

Warnings

Allergy alert

Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin.  Symptoms may include:

  • asthma (wheezing)
  • blisters
  • facial swelling
  • hives
  • rash
  • shock
  • skin reddening

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning

This product contains a non steroidal anti-inflammatory drug(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 

NSAID's except aspirin increases 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 surgery

Ask a doctor before use if
  • the stomach bleeding warning applies to you
  • you have a history of stomach problems,such as a heartburn
  • you have a high blood pressure, heart disease, liver cirrhosis or kidney disease
  • you are taking a diuretic
  • you have problems or serious side effects taking pain relievers or fever reducers
  • you have asthma

Ask a doctor or pharmacist before use if you are
  • under a doctor 's care for any serious conditions
  • 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 a doctor if

you experience any of following sign 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


you have difficulty swallowing


it feel 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 profession 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 complication during the delivery.

Keep out of reach of children. In case of overdose, get medical help or contact a position control center right away (1-800-222-1222)

Direction
*Do not take more than as 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 table every 8 to 12 hours while symptoms last
- for the first dose you may have 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 any 24 hour period
*Children under 12 years- ask a doctor

Other information
  • each tablet contains: sodium 20 mg
  • store between 20°-25°C(68-77°F). 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*, maize starch*, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate*, stearic acid*, titanium dioxide.

*contains one or more of these ingredients

Distributed By: Greenbrier International, Inc. Chesapeake, VA 23320

PRINCIPAL DISPLAY PANEL - 220 mg Bottle Carton

ASSUR XED

SEE NEW WARNINGS INFORMATION

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

15 TABLETS (OVAL-SHAPED)

NAPROXEN SODIUM 
naproxen sodium tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-0400
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPROXEN SODIUM (NAPROXEN) NAPROXEN SODIUM220 mg
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 400 
POVIDONES 
CROSCARMELLOSE SODIUM 
CELLULOSE, MICROCRYSTALLINE 
SILICON DIOXIDE 
MAGNESIUM STEARATE 
HYPROMELLOSES 
TITANIUM DIOXIDE 
FD&C BLUE NO. 2 
Product Characteristics
ColorblueScoreno score
ShapeOVALSize18mm
FlavorImprint Code144
Contains    
Packaging
#Item CodePackage Description
1NDC:68210-0400-01 BOTTLE in 1 CARTON
115 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
2NDC:68210-0400-11 BOTTLE in 1 CARTON
250 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09054511/22/2017
Labeler - SPIRIT PHARMACEUTICALS,LLC (179621011)
Establishment
NameAddressID/FEIOperations
Marksans Pharma Ltd925822975manufacture(68210-0400)

Revised: 12/2017
 
SPIRIT PHARMACEUTICALS,LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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