NAPROXEN SODIUM - naproxen sodium tablet, coated 
AAA Pharmaceutical, Inc.

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Naproxen Sodium Tablets

Drug Facts

Active ingredient (in each caplet)

Naproxen sodium 220 mg (naproxen 200 mg) (NSAID1)


1
nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

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

  • side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
  • 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
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

Inactive ingredients

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

Distributed by:
AAA Pharmaceutical, Inc.
681 Main Street
Lumberton, NJ 08048

PRINCIPAL DISPLAY PANEL - 24 Caplet Bottle Carton

RESTORE u

NDC 57344-145-01

COMPARE TO THE ACTIVE
INGREDIENT IN ALEVE®

Naproxen
Naproxen Sodium Tablets, 220 mg

Pain Reliever / Fever Reducer
(NSAID)

24 COATED CAPLETS** (**capsule shaped tablets)

Principal Display Panel
NAPROXEN SODIUM  
naproxen sodium tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:57344-145
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN SODIUM 220 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
POVIDONES (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Color BLUE Score no score
Shape OVAL (Biconvex) Size 12mm
Flavor Imprint Code I7
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:57344-145-01 1 in 1 CARTON
1 24 in 1 BOTTLE, PLASTIC
2 NDC:57344-145-02 1 in 1 CARTON
2 50 in 1 BOTTLE, PLASTIC
3 NDC:57344-145-03 1 in 1 CARTON
3 100 in 1 BOTTLE, PLASTIC
4 NDC:57344-145-04 1 in 1 CARTON
4 150 in 1 BOTTLE, PLASTIC
5 NDC:57344-145-05 1 in 1 CARTON
5 200 in 1 BOTTLE, PLASTIC
6 NDC:57344-145-06 1 in 1 CARTON
6 300 in 1 BOTTLE, PLASTIC
7 NDC:57344-145-07 500 in 1 BOTTLE, PLASTIC
8 NDC:57344-145-08 200 in 1 BOTTLE, PLASTIC
9 NDC:57344-145-10 400 in 1 BOTTLE, PLASTIC
10 NDC:57344-145-11 600 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079096 12/15/2012
Labeler - AAA Pharmaceutical, Inc. (181192162)

Revised: 1/2013
Document Id: 5d765fcc-bfa7-4791-b533-b28f73b01f40
Set id: 5ea3217d-845d-4781-b849-6b00babdc214
Version: 1
Effective Time: 20130104
 
AAA Pharmaceutical, Inc.