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Name:Naproxen Sodium (nsaid)fever Reducer/ Pain Reliever
Manufacturer:Amneal Pharmaceuticals
Category:Over-the-counter (OTC) Marketed Drugs


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

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

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

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

WARNINGS

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

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

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

Stomach bleeding warning: This product contains an (NSAID), which may cause severe 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 prescription or nonprescription NSAIDs (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

  • the stomach bleeding problems apply to you
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you are taking a diuretic
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • you have asthma

Ask a doctor or pharmacist before use if you are

  • 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 experience any of the following signs of stomach bleeding
  • feel faint
  • vomit blood
  • have bloody or black stools
  • have stomach pain that does not get better
  • 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
  • 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
  • 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 to 25°C (68 to77°F). Avoid high humidity and excessive heat above 40°C (104°F)

Inactive ingredients

croscarmellose sodium, FD&C Blue #2, 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. 06-2010

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

91f51db3-figure-01
91f51db3-figure-02

NAPROXEN SODIUM (NSAID)  FEVER REDUCER/ PAIN RELIEVER
naproxen sodium tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC: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
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
# Item Code Package Description Multilevel Packaging
1 NDC:53746-191-24 24 TABLET ( TABLET) in 1 BOTTLE None
2 NDC:53746-191-05 500 TABLET ( 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 Item Code (Source) NDC: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
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
# Item Code Package Description Multilevel Packaging
1 NDC:53746-192-24 24 TABLET ( TABLET) in 1 BOTTLE None
2 NDC:53746-192-05 500 TABLET ( 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: 07/2010 Amneal Pharmaceuticals



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


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