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Naproxen Sodium by Kinray LLC

Medically reviewed on April 30, 2018

Dosage form: tablet, coated
Ingredients: NAPROXEN SODIUM 220mg
Labeler: Kinray LLC
NDC Code: 61715-098

Naproxen Sodium

Drug Facts

Active ingredient (in each tablet)

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:
    • minor pain of arthritis
    • muscular aches
    • backache
    • menstrual cramps
    • headache
    • toothache
    • the common cold
  • 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
  • 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 asthma
  • you have problems or serious side effects from taking pain relievers or fever reducers

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
  • long term continuous use may increase the risk of heart attack or stroke

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
  • you have difficulty swallowing
  • it feels like the pill is stuck in your throat
  • you develop heartburn
  • redness or swelling is present in the painful area
  • any new symptoms appear

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.

Directions
  • do not take more than directed
  • the smallest effective dose should be used
  • do not take longer than 10 days, unless directed by a doctor (see Warnings)
  • drink a full glass of water with each dose
adults and children 12 years and older
  • take 1 tablet every 8 to 12 hours while symptoms last
  • for the first dose you may take 2 tablets within the first hour
  • do not exceed 2 tablets in any 8- to 12-hour period
  • do not exceed 3 tablets in a 24-hour period
children under 12 years
  • ask a doctor

Other information
  • each tablet contains: sodium 20 mg
  • store at 20º-25ºC (68º-77ºF). Avoid high humidity and excessive heat above 40ºC (104ºF).
  • retain carton for complete product information

Inactive ingredients

croscarmellose sodium, FD&C blue #2, macrogol, magnesium stearate, polyvinyl alcohol, povidone, pregelatinized starch, talc, titanium dioxide

Questions or comments?

Call 844-705-4384

Distributed by: Kinray LLC., Whitestone, NY 11357

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Carton

Preferred
plus

Pharmacy
®

Pain Reliever/
Fever Reducer
(NSAID)

  • With 8 to 12
    Hour Dosing

NDC 61715-098-51
†Compare to Aleve® Tablets

Non-Prescription Strength

Naproxen
Sodium

Naproxen Sodium Tablets, 220mg

SATISFACTION
Preferred
plus

Pharmacy®
GUARANTEED

100 Tablets

NAPROXEN SODIUM 
naproxen sodium tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61715-098
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPROXEN SODIUM (NAPROXEN) NAPROXEN SODIUM220 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
FD&C BLUE NO. 2 
POLYETHYLENE GLYCOLS 
MAGNESIUM STEARATE 
POLYVINYL ALCOHOL 
POVIDONES 
STARCH, CORN 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorBLUEScoreno score
ShapeROUNDSize10mm
FlavorImprint CodeI3
Contains    
Packaging
#Item CodePackage Description
1NDC:61715-098-501 BOTTLE, PLASTIC in 1 CARTON
150 TABLET, COATED in 1 BOTTLE, PLASTIC
2NDC:61715-098-511 BOTTLE, PLASTIC in 1 CARTON
2100 TABLET, COATED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07909604/25/2014
Labeler - Kinray LLC (012574513)

 
Kinray 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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