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

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

Warnings

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

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

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:

• are age 60 or older
• have had stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug
• take other drugs containing an NSAID (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 you have

• problems or serious side effects from taking pain relievers or fever reducers
• stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain
• ulcers
• asthma
• high blood pressure
• taken a diuretic
• bleeding problems
• heart or kidney disease
• reached age 60 or older

Ask a doctor or pharmacist before use if you are

• taking any other drug containing an NSAID (prescription or nonprescription)
• taking a blood thinning (anticoagulant) or steroid drug
• 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
• 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

• you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding.
• 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
• stomach pain or upset gets worse or lasts
• 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

• do not take more than directed
• the smallest effective dose should be used
• do not take longer than 10 days, unless directed by a doctor (see Warnings)
• drink a full glass of water with each dose

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

• each tablet contains: sodium 20 mg
• store at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F).

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

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®**

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

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®**

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: 05/2009Goldline Laboratories, Inc.