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Naproxen Sodium by Shopko Stores Operating Co., LLC.

Medically reviewed on Jan 15, 2018

Dosage form: capsule, liquid filled
Ingredients: NAPROXEN SODIUM 220mg
Labeler: Shopko Stores Operating Co., LLC.
NDC Code: 37012-174

Drug Facts

Active ingredient (in each capsule)

Naproxen sodium 220 mg

(naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

Uses
  • temporarily relieves minor aches and pains due to:
    • minor pain of arthritis
    • backache
    • headache
    • the common cold
    • muscular aches
    • menstrual cramps
    • toothache
  • 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
    • have bloody or black stools
    • vomit blood
    • 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
  • 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
  • swallow whole; do not crush, chew, or dissolve
  • store at 20-25ºC (68-77ºF). Avoid high humidity and excessive heat above 40ºC (104ºF).
  • read all directions and warnings before use. Keep carton.

Inactive ingredients

FD&C blue #1, gelatin, glycerin, lactic acid, mannitol, pharmaceutical ink, polyethylene glycol 600, povidone K30, propylene glycol, purified water, sorbitan, sorbitol

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

**Compare to the active ingredient of Aleve® Liquid Gels

Naproxen Sodium

Capsules, 220 mg (NSAID)

Pain Reliever / Fever Reducer

Strength to Last 12 Hours

Liquid Gels†

†(Liquid Filled Capsules)

**This product is not manufactured or distributed by Bayer HealthCare, LLC., owner of the registered trademark Aleve® Liquid Gels.

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Packaged by: PL Developments

200 Hicks Street

Westbury, NY 11590, USA

©2014 Shopko Stores Operating Co., LLC

www.shopko.com

Product Label

Naproxen Sodium Pain Reliever/Fever Reducer

NAPROXEN SODIUM 
naproxen sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37012-174
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 GLYCOL 600 
POVIDONE K30 
PROPYLENE GLYCOL 
WATER 
SORBITAN 
SORBITOL 
Product Characteristics
ColorBLUEScoreno score
ShapeCAPSULESize21mm
FlavorImprint CodeNPX
Contains    
Packaging
#Item CodePackage Description
1NDC:37012-174-401 BOTTLE, PLASTIC in 1 BOX
140 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02192012/31/2014
Labeler - Shopko Stores Operating Co., LLC. (023252638)

 
Shopko Stores Operating Co., LLC.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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