NAPROXEN CAPLETS- naproxen sodium 220 mg tablet 
Allegiant Health

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Analgen - Naproxen Sodium 220mg

Active ingredient

Naproxen sodium 220mg

Purpose

Pain reliever/fever reducer

Uses

temporarily relieves minor aches and pains due to:

Warnings

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

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

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.

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 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
  • 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 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
  • 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.

Directions

Adults and children 12 years and older: 

Children under 12 years:

Other information

Inactive ingredients

corn starch, FD&C blue #2 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, purified water, sodium starch glycolate, stearic acid, titanium dioxide

Questions or Comments?

Call 1-888-952-0050

Monday through Friday 9AM- 5PM EST.

Principal Display Panel

Analgen Naproxen

Analgen Naproxen


NAPROXEN CAPLETS 
naproxen sodium 220 mg tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-394
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 1000 (UNII: U076Q6Q621)  
POVIDONE (UNII: FZ989GH94E)  
WATER (UNII: 059QF0KO0R)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorblueScoreno score
ShapeOVALSize10mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69168-394-241 in 1 CARTON12/23/2014
124 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09054512/23/2014
Labeler - Allegiant Health (079501930)

Revised: 6/2019
Document Id: f6b88aa9-7608-49e8-9841-2cf702715869
Set id: 07120764-7c33-4c07-9367-40956d970c60
Version: 3
Effective Time: 20190606
 
Allegiant Health