NAPROXEN SODIUM TABLETS USP, 220 mg

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 TypeHUMAN OTC DRUGNDC Product Code (Source)0182-1097
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Naproxen Sodium (Naproxen) Naproxen Sodium220 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 2 
hypromellose 
magnesium stearate 
cellulose, microcrystalline 
polyethylene glycol 
povidone 
talc 
titanium dioxide 
Product Characteristics
ColorBLUE (Light Blue) Score no score
ShapeROUNDSize10mm
FlavorImprint Code L490
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
10182-1097-161 BOTTLE In 1 CARTONcontains a BOTTLE
130 TABLET In 1 BOTTLEThis package is contained within the CARTON (0182-1097-16)
20182-1097-191 BOTTLE In 1 CARTONcontains a BOTTLE
250 TABLET In 1 BOTTLEThis package is contained within the CARTON (0182-1097-19)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07466105/15/2009

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