EQUATE NAPROXEN SODIUM- naproxen sodium capsule, liquid filled 
Wal-Mart Stores Inc

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Active ingredient (in each capsule)

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

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

  • temporarily relieves minor aches and pains due to:
  • headache
  • muscular aches
  • minor pain of arthritis
  • toothache
  • backache
  • the common cold
  • menstrual cramps
  • 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 you are

  • 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 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
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • stomach pain or upset gets worse or lasts
  • redness or swelling is present in the painful area
  • any new symptoms appear
  • you have difficulty swallowing
  • it feels like the capsule is stuck in your throat

If pregnant or breast-feeding,

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
  • if taken with food, this product may take longer to work

adults and

children 12 years

and older:
  • take 1 capsule every 8 to 12 hours while symptoms last
  • for the first dose you may take 2 capsules within the first hour
  • do not exceed 2 capsules in any 8- to 12- hour period
  • do not exceed 3 capsules in a 24 hour period

children

under 12

years:
  • ask a doctor

Other information

  • each capsule contains: sodium 20 mg
  • store at 20-25°C (68-77°F) avoid high humidity and excessive heat above 40°C (104°F).
  • do not use if printed foil under cap is broken or missing
  • read all directions and warnings before use. Keep carton.

Inactive ingredients

FD&C Blue #1, gelatin, glycerin, lactic acid, mannitol, pharmaceutical ink, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol

Questions or comments?

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SEE NEW WARNINGS INFORMATION

Naproxen Sodium Capsules, 220 mg (NSAID)

Pain Reliever/Fever Reducer

Actual Size

220 mg

**Liquid Filled Capsules

Naproxen Sodium Capsules, 220 mg (NSAID) Carton Image 1

Naproxen Sodium Capsules, 220 mg (NSAID) Carton Image 1

Naproxen Sodium Capsules, 220 mg (NSAID) Carton Image 2

Naproxen Sodium Capsules, 220 mg (NSAID) Carton Image 2

EQUATE NAPROXEN SODIUM 
naproxen sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-742
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPROXEN SODIUM (NAPROXEN) NAPROXEN SODIUM220 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
GELATIN 
GLYCERIN 
LACTIC ACID 
MANNITOL 
POLYETHYLENE GLYCOLS 
POVIDONE 
PROPYLENE GLYCOL 
WATER 
SORBITAN 
SORBITOL 
Product Characteristics
ColorBLUE (Clear) Scoreno score
ShapeCAPSULESize20mm
FlavorImprint Code 742
Contains    
Packaging
#Item CodePackage Description
1NDC:49035-742-271 in 1 CARTON
180 in 1 BOTTLE
2NDC:49035-742-601 in 1 CARTON
220 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02192007/26/2011
Labeler - Wal-Mart Stores Inc (051957769)

Revised: 11/2011
Document Id: 414da4d8-919a-4441-8ac4-95c4870904c1
Set id: 414da4d8-919a-4441-8ac4-95c4870904c1
Version: 1
Effective Time: 20111128
 
Wal-Mart Stores Inc