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Naproxen Sodium by Kinray

Medically reviewed on May 30, 2018

Dosage form: tablet
Ingredients: NAPROXEN SODIUM 220mg
Labeler: Kinray
NDC Code: 61715-060

Drug Facts

Active ingredient (in each caplet)

Naproxen sodium, USP 220 mg (naproxen 200 mg) (NSAID)**
**nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/ fever reducer

Uses
  • temporarily relieves minor aches and pain 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 everyday 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
  • you have difficulty swallowing
  • it feels like the pill is stuck in your throat
  • 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. (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​​​
Adults and children 12 years and older
  • take 1 caplet every 8 to 12 hours while symptoms last
  • for the first dose you may take 2 caplets within the first hour
  • do not exceed 2 caplets in any 8 to 12 hour period
  • do not exceed 3 caplets in a 24-hour period
Children under 12 years
  • ask a doctor

Other Information
  • ​each caplet contains: ​sodium 20 mg 
  • store at 20o- 25oC (68o- 77oF). Avoid high humidity and excessive heat above 40°C (104°F)

Inactive Ingredients:

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

Questions or comments? 1-877-586-7979

PRINCIPAL DISPLAY PANEL - 220 mg TABLET CARTON

Preferred Plus Pharmacy

NDC 61715-060-50

SEE NEW WARNINGS INFORMATION

*Compare to the Active Ingredient in Aleve®

Naproxen Sodium Tablets, USP 220 mg

 Pain Reliever/Fever Reducer (NSAID)

50 COATED CAPLETS†

†CAPSULE-SHAPED TABLETS

Distributed By:

Kinray, Inc., Whitestone, NY 11357

(c) 2013 Kinray Inc., All Rights Reserved, PREFERRED PLUS, PREFERRED PLUS ++++ and the PREFERRED PLUS logo are trademarks and/or registered trademarks of Kinray Inc. All other marks are property of their respective owners.

NAPROXEN SODIUM 
naproxen sodium tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61715-060
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 
POVIDONE 
STARCH, PREGELATINIZED CORN 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorblueScoreno score
ShapeOVAL (Capsule-Shaped) Size12mm
FlavorImprint Code17
Contains    
Packaging
#Item CodePackage Description
1NDC:61715-060-501 BOTTLE, PLASTIC in 1 CARTON
150 TABLET (TABLET) in 1 BOTTLE, PLASTIC
2NDC:61715-060-511 BOTTLE, PLASTIC in 1 CARTON
2100 TABLET (TABLET) in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07909611/25/2009
Labeler - Kinray (012574513)
Registrant - Aphena Pharma Solutions - Kentucky, LLC (557054835)
Establishment
NameAddressID/FEIOperations
Aphena Pharma Solutions - Kentucky, LLC557054835repack(61715-060)
Establishment
NameAddressID/FEIOperations
Amneal Pharmaceuticals831227801manufacture(61715-060)

 
Kinray

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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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