NAPROXEN SODIUM - naproxen sodium tablet, coated 
Goldline Laboratories, Inc.

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NAPROXEN SODIUM 
TABLETS USP, 220 mg

PAIN RELIEVER / FEVER REDUCER (NSAID)

Drug Facts

Active ingredient (in each tablet)

Naproxen sodium 220 mg
(naproxen 200 mg) (NSAID)1


1
nonsteroidal anti-inflammatory drug

Purposes

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 no. 2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide

Questions?

call 1-888-838-2872, weekdays, 8 AM - 5 PM Eastern Time

**This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Aleve®.

Dist. by: GOLDLINE LABORATORIES, INC.
Sellersville, PA 18960
Dist. 1996 0409REV 21

PRINCIPAL DISPLAY PANEL - 24 Tablets Bottle

Goldline

TAMPER-EVIDENT
NDC 0182-1097-16

NAPROXEN
SODIUM
TABLETS USP, 220 mg

PAIN RELIEVER / FEVER REDUCER (NSAID)

STRENGTH TO LAST 12 HOURS

24 TABLETS

Principle Display Panel - 24 Tablets Bottle

PRINCIPAL DISPLAY PANEL - 24 Tablets Carton

Goldline

KEEP CARTON FOR REFERENCE

NDC 0182-1097-16
TAMPER-EVIDENT

NAPROXEN
SODIUM
TABLETS USP, 220 mg

PAIN RELIEVER / FEVER REDUCER (NSAID)

ALL DAY RELIEF
STRENGTH TO LAST 12 HOURS

24 TABLETS

ACTUAL SIZE

Compare to the active ingredient of Aleve®**

Principle Display Panel - 24 Tablets Carton

PRINCIPAL DISPLAY PANEL - 50 Tablets Bottle

Goldline

TAMPER-EVIDENT
NDC 0182-1097-19

NAPROXEN
SODIUM
TABLETS USP, 220 mg

PAIN RELIEVER / FEVER REDUCER (NSAID)

STRENGTH TO LAST 12 HOURS

50 TABLETS

Principle Display Panel - 50 Tablets Bottle

PRINCIPAL DISPLAY PANEL - 50 Tablets Carton

Goldline

KEEP CARTON FOR REFERENCE

NDC 0182-1097-19
TAMPER-EVIDENT

NAPROXEN
SODIUM
TABLETS USP, 220 mg

PAIN RELIEVER / FEVER REDUCER (NSAID)

ALL DAY RELIEF
STRENGTH TO LAST 12 HOURS

50 TABLETS

ACTUAL SIZE

Compare to the active ingredient of Aleve®**

Principle Display Panel - 50 Tablets Carton

NAPROXEN SODIUM 
naproxen sodium   tablet, coated
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 0182-1097
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
FD&C BLUE NO. 2  
hypromellose  
magnesium stearate  
cellulose, microcrystalline  
polyethylene glycol  
povidone  
talc  
titanium dioxide  
Product Characteristics
Color BLUE (Light Blue) Score no score
Shape ROUND Size 10mm
Flavor Imprint Code L490
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 0182-1097-16 1 BOTTLE In 1 CARTON contains a BOTTLE
1 30 TABLET In 1 BOTTLE This package is contained within the CARTON (0182-1097-16)
2 0182-1097-19 1 BOTTLE In 1 CARTON contains a BOTTLE
2 50 TABLET In 1 BOTTLE This package is contained within the CARTON (0182-1097-19)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074661 05/15/2009

Labeler - Goldline Laboratories, Inc. (032349292)
Revised: 05/2009 Goldline Laboratories, Inc.