NAPROXEN SODIUM description, usages, side effects, indications, overdosage, supplying and lots more!

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NAPROXEN SODIUM

SPIRIT PHARMACEUTICALS,LLC

NAPROXEN SODIUM TABLETS, USP 220 mg


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active ingredients (in each tablet) Purpose
Naproxen Sodium 220 mg Pain reliever
(Naproxen Sodium 200mg) (NSAID) Nonsteroidal anti-inflammatory drug Fever reducer

NAPROXEN SODIUM Uses

  • *temporarily relieves minor aches and pain due to :
    • *backache
    • *headache
    • *menstrul cramps
    • *minor pain of arthritis
    • *muscular aches
    • *the common cold
    • *toothache
  • *temporarily reduces fever

Warnings

Allergy alerts

Naproxen sodium may cause a severe allergic reaction; especially in people allergic to aspirin.

Symptoms may include:

  • *asthma(wheezing)
  • *blister
  • *facial swelling
  • *hives
  • *rash
  • *shock
  • *skin reddening

if an allergic reaction occurs, stop use and seek medical people right away

Stomach bleeding waring

This product contains a non steroidal anti-inflammatory drug(NASID), which may cause severe stomach bleeding. The chance is higher if you :

  • ❿are age 60 and older
  • ❿have had stomach ulcers or bleeding problems
  • ❿take a blood thinning (anticoagulant) or steroid drug
  • ❿take other drugs containing prescription or nonprescription NASIDs (Aspirin, ibuprofen,naproxen, or others)
  • ❿have 3 or more alcoholic drinks every day while using this product
  • ❿take 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 surgery

Ask a doctor before use if

  • *the stomach bleeding warning applies to you
  • ❿you have a history of stomach problems,such as a heartburn
  • ❿you have a high blood pressure,heart disease,liver cirrhosis or kidney disease
  • ❿you are taking diuretic
  • ❿you have a problem or serious side effects taking pain revilers or fever reducer
  • ❿you have asthma

Ask doctor or pharmacist before use if you are

  • *under a doctor 's care for any serious conditions
  • *taking any other drug

WHEN USING THIS PRODUCT

  • *take with food or milk if stomach upsets occur
  • *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

  • ❿you experience any of following sign of stomach bleeding feel faint , vomit blood , have a bloody or black sttols have a 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 feel 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 profession 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 complication during the delivery.

Keep out of reach of children : in case of overdose, get medical help or contact a position control center right away (1-800-222-1222)

Direction

*Do not take more than as directed
*the smallest effective does should be used
*drink a full glass of water with each dose adults and children 12 years of age and older  
-take 1 table every 8 to 12 hours while symptoms last
- for the first dose you may have 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 any 24 hour period
*Children under 12 years - ask a doctor

NAPROXEN SODIUM Other information

  • * each tablet contains : 20 mg sodium

Store at room temperature

Inactive ingredients

colloidal silicon dioxide,croscarmellose sodium, FD &C blue #2 lake,hypromellose, magnesium stearate, microcrystalline cellulose, polyethy lene glycol, povidone, titanium dioxide

Distributed By: Greenbrier International, Inc. Chesapeake, VA 23320

PRINCIPAL DISPLAY PANEL - 220 mg Bottle Carton

ASSURXED

SEE NEW WARNINGS INFORMATION

Compare to the active
ingredient in Aleve ®*

ALL DAY
PAIN RELIEF

NAPROXEN SODIUM TABLETS, USP 220 mg

PAIN RELIEVER/FEVER REDUCER (NSAID)

  • STRENGTH TO LAST 12 HOURS

15 TABLETS (OVAL-SHAPED)

NAPROXEN SODIUM

NAPROXEN SODIUM

NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68210-0400
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
naproxen sodium NAPROXEN 220 mg

Inactive Ingredients

Ingredient Name Strength
polyethylene glycol 400
povidone
CROSCARMELLOSE SODIUM
cellulose, microcrystalline
SILICON DIOXIDE
water
MAGNESIUM STEARATE
HYPROMELLOSES
titanium dioxide
FD&C BLUE NO. 2
ALUMINUM OXIDE

Product Characteristics

Color Size Imprint Code Shape
BLUE 18 mm 144 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68210-0400-0 15 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090545 2011-08-01


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Be sure to consult your doctor before taking any medication!
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