NAPROXEN SODIUM (NSAID) FEVER REDUCER/ PAIN RELIEVER - naproxen sodium tablet 
Amneal Pharmaceuticals

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Naproxen Sodium Tablets, USP (NSAID)
Pain Reliever/ Fever Reducer
220 mg

Compared to the active ingredient of Aleve® †

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

WARNINGS

Allergy alert:  Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if you:

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

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 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

Inactive ingredients

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

Questions or Comments?

Call 1-877-835-5472

Monday though Friday 9AM – 5PM EST.

Distributed by:

Amneal Pharmaceuticals

Glasgow, KY 42141

This product is not manufactured or distributed by Bayer Healthcare, LLC., distributor of Aleve®

Rev. 09-2008

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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160bed0a-figure-02

NAPROXEN SODIUM (NSAID)  FEVER REDUCER/ PAIN RELIEVER
naproxen sodium   tablet
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 53746-191
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NAPROXEN SODIUM (NAPROXEN) NAPROXEN SODIUM 220 mg
Inactive Ingredients
Ingredient Name Strength
No Inactive Ingredients Found
Product Characteristics
Color BLUE Score no score
Shape ROUND (Biconvex) Size 10mm
Flavor Imprint Code I3
Contains Naproxen Sodium 220 mg (Naproxen 200 mg)
Packaging
# NDC Package Description Multilevel Packaging
1 53746-191-24 24 TABLET In 1 BOTTLE None
2 53746-191-05 500 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079096 11/25/2009

NAPROXEN SODIUM (NSAID)  FEVER REDUCER/ PAIN RELIEVER
naproxen sodium   tablet
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 53746-192
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NAPROXEN SODIUM (NAPROXEN) NAPROXEN SODIUM 220 mg
Inactive Ingredients
Ingredient Name Strength
No Inactive Ingredients Found
Product Characteristics
Color BLUE Score no score
Shape OVAL (Biconvex) Size 12mm
Flavor Imprint Code I7
Contains Naproxen Sodium 220 mg (Naproxen 200 mg)
Packaging
# NDC Package Description Multilevel Packaging
1 53746-192-24 24 TABLET In 1 BOTTLE None
2 53746-192-05 500 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079096 11/25/2009

Labeler - Amneal Pharmaceuticals (831227801)
Registrant - Amneal Pharmaceuticals (831227801)
Establishment
Name Address ID/FEI Operations
Amneal Pharmaceuticals 831227801 ANALYSIS, MANUFACTURE
Establishment
Name Address ID/FEI Operations
Integrated Pharmaceutical Packaging 829375455 RELABEL, REPACK
Revised: 11/2009 Amneal Pharmaceuticals