NAPROXEN SODIUM 220MG- naproxen sodium 220mg tablet, coated 
Allegiant Health

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394 - Naproxen Sodium 220mg

Active ingredient(s)

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

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Use(s)

temporarily relieves minor aches and pains due to:

Warnings

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

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 a 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

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 (1-800-222-1222) right away

Other 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

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

Directions

Adults and children 12 years and older:

Children under 12 years: 

Other information

Storage

Inactive ingredients

Inactive ingredients FD&C blue #2 aluminum
lake, hypromellose, microcrystalline cellulose,
polyethylene glycol, povidone, titanium dioxide
May contain: corn starch, croscarmellose sodium,
magnesium stearate, purified water, silicon

Questions

Call 1-888-952-0050 Monday through Friday 9AM- 5PM EST.

Principal Display Panel

Naprozen

Naproxen



NAPROXEN SODIUM 220MG 
naproxen sodium 220mg tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-395
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
STARCH, CORN (UNII: O8232NY3SJ)  
FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
WATER (UNII: 059QF0KO0R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM STARCH GLYCOLATE TYPE B (UNII: SP4S77AHO6)  
Product Characteristics
ColorblueScoreno score
ShapeOVALSize12mm
FlavorImprint Code 220
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69168-395-17300 in 1 BOTTLE; Type 0: Not a Combination Product04/21/2021
2NDC:69168-395-5050 in 1 BOTTLE; Type 0: Not a Combination Product05/18/2022
3NDC:69168-395-0710 in 1 BOTTLE; Type 0: Not a Combination Product05/04/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09054505/04/2011
Labeler - Allegiant Health (079501930)

Revised: 4/2021
Document Id: 08dc5597-5820-47c7-aec4-72336b5b7089
Set id: 14554f05-14e1-4c52-99ce-94561c42c0da
Version: 9
Effective Time: 20210421
 
Allegiant Health