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Name:Naproxen Sodium
Manufacturer:Goldline Laboratories, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


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

  • 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
  • high blood pressure
  • taken a diuretic
  • reached age 60 or older
  • bleeding problems
  • heart or kidney disease

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
  • long term continuous use may increase the risk of heart attack or stroke

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

carnauba wax, FD&C blue no. 2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide

phone image 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.
Miami, FL 33137
Dist. 1996 0908REV 21

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 Item Code (Source) NDC: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
Carnauba Wax  
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
# Item Code Package Description Multilevel Packaging
1 NDC:0182-1097-16 1 BOTTLE ( BOTTLE) in 1 CARTON contains a BOTTLE
1 24 TABLET, COATED ( TABLET) in 1 BOTTLE This package is contained within the CARTON (0182-1097-16)
2 NDC:0182-1097-19 1 BOTTLE ( BOTTLE) in 1 CARTON contains a BOTTLE
2 50 TABLET, COATED ( 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 12/01/2008

Labeler - Goldline Laboratories, Inc. (032349292)

Revised: 12/2009 Goldline Laboratories, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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