NAPROXEN SODIUM- naproxen sodium tablet, film coated, extended release 
SPIRIT PHARMACEUTICALS,LLC

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NAPROXEN SODIUM TABLETS, USP 220 mg

Drug Facts

Naproxen sodium 220 mg

(naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

Pain reliever/

fever reducer

Uses

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

Ask a doctor before use if

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

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)

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 one tablet every 8 to 12 hours while symptoms last
  • for the first dose you may take within the first hour
  • do not exceed 2 tablets in any 8 to 12 hours period
  • do not exceed 3 tablets in 24 hour period
 Children under 12 years:
  •  Ask a doctor

Other information

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

Questions or comments?

1-888-333-9792

PRINCIPAL DISPLAY PANEL

CABINET

NAPROXEN SODIUM TABLETS, USP 220 mg

PAIN RELIEVER/FEVER REDUCER (NSAID)

image description

NAPROXEN SODIUM 
naproxen sodium tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-4096
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN SODIUM220 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
STARCH, CORN (UNII: O8232NY3SJ)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE K30 (UNII: U725QWY32X)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorblueScoreno score
ShapeOVALSize18mm
FlavorImprint Code 220
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68210-4096-1365 in 1 BOTTLE; Type 0: Not a Combination Product07/02/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09135307/02/2020
Labeler - SPIRIT PHARMACEUTICALS,LLC (179621011)

Revised: 12/2023
Document Id: 0bf2dd18-a81b-f8b0-e063-6394a90a575d
Set id: a690dc39-95f2-4853-a291-05d7dc9a1551
Version: 6
Effective Time: 20231207
 
SPIRIT PHARMACEUTICALS,LLC