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Name:Naproxen Sodium
Manufacturer:Western Family Foods Inc
Category:Over-the-counter (OTC) Marketed Drugs


Western Family Naproxen Sodium Capsules, 220 mg (NSAID) Drug Facts

NAPROXEN SODIUM - naproxen sodium capsule, liquid filled 
Western Family Foods Inc

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Western Family Naproxen Sodium Capsules, 220 mg (NSAID) Drug Facts

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?

1-800-719-9260

Package/Label Principal Display Panel

See New Warnings Information

Naproxen Sodium Capsules, 220 mg (NSAID)-

Pain Reliever/Fever Reducer

**Liquid Filled Capsules

Actual Size

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

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

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

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


NAPROXEN SODIUM 
naproxen sodium capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55312-742
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NAPROXEN SODIUM (NAPROXEN) NAPROXEN SODIUM 220 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1  
GELATIN  
GLYCERIN  
LACTIC ACID  
MANNITOL  
POLYETHYLENE GLYCOL  
POVIDONE  
PROPYLENE GLYCOL  
WATER  
SORBITAN  
SORBITOL  
Product Characteristics
Color BLUE (Clear) Score no score
Shape CAPSULE Size 20mm
Flavor Imprint Code 742
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55312-742-58 1 BOTTLE ( BOTTLE) in 1 CARTON contains a BOTTLE
1 40 CAPSULE, LIQUID FILLED ( CAPSULE) in 1 BOTTLE This package is contained within the CARTON (55312-742-58)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021920 01/18/2011

Labeler - Western Family Foods Inc (192166072)

Revised: 06/2011 Western Family Foods Inc



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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