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Naproxen Sodium by NuCare Pharmaceuticals,Inc.

Dosage form: tablet
Ingredients: NAPROXEN SODIUM 220mg
Labeler: NuCare Pharmaceuticals,Inc.
NDC Code: 68071-3223

gc 951

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 pain due to:

  • backache
  • muscular aches
  • minor pain of arthritis
  • 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
  • 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
  • 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 doctor if

  • you experience any of the following signs of stomach bleeding:
    • feel faint
    • vomit blood
    • have bloody or black stools
    • have a stomach pain that dose 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.

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 tablet every 8 to12 hours while symptoms last
  • for first dose you may take 2 tablets with in 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

Storage

 

  • Store at 20-25 oC (68-77 oF). Avoid high humidity and excessive heat above 40 0C (104 0F)

Other information
  • each tablet contains: sodium 20 mg
  • If side effects occur, you may report side effects to
    FDA at 1-800-FDA-1088

Inactive ingredients

Colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2 lake, Hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone,  titanium dioxide.

 

Questions or comments?

Call 1-800-540-3765

Principal Display Panel

NAPROXEN SODIUM 
naproxen sodium tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68071-3223(NDC:57896-951)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPROXEN SODIUM (NAPROXEN) NAPROXEN SODIUM220 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
FD&C BLUE NO. 2 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 
POVIDONE 
TITANIUM DIOXIDE 
Product Characteristics
ColorblueScoreno score
ShapeOVALSize12mm
FlavorImprint Code144
Contains    
Packaging
#Item CodePackage Description
1NDC:68071-3223-121 TABLET in 1 BOTTLE
2NDC:68071-3223-330 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09054505/01/2012
Labeler - NuCare Pharmaceuticals,Inc. (010632300)
Establishment
NameAddressID/FEIOperations
NuCare Pharmaceuticals,Inc.010632300repack(68071-3223)

 
NuCare Pharmaceuticals,Inc.

← See all Naproxen Sodium brands

Medically reviewed on Jan 22, 2018

Further information

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

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