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Naproxen Sodium by Physicians Total Care, Inc.

Medically reviewed on July 16, 2018

Dosage form: tablet
Ingredients: NAPROXEN SODIUM 220mg
Labeler: Physicians Total Care, Inc.
NDC Code: 54868-5308

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.

Inactive ingredients

croscarmellose sodium, FD&C Blue #2, macrogol, magnesium stearate, polyvinyl alcohol, povidone, pregelatinized starch, talc and titanium dioxide.

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)

Questions or Comments?

Call 1-877-835-5472

Monday though Friday 9AM – 5PM EST.

Distributed by:

Amneal Pharmaceuticals

Glasgow, KY 42141


Relabeling of "Additional barcode label" by:

Physicians Total Care, Inc.
Tulsa, OK      74146

This product is not manufactured or distributed by Bayer Healthcare, LLC., distributor of Aleve®

Rev. 06-2010

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Naproxen sodium 220 mg

(naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

NDC 54868-5308-0
Bottle of 100
NAPROXEN SODIUM 
naproxen sodium tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-5308(NDC:53746-192)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPROXEN SODIUM (NAPROXEN) NAPROXEN SODIUM220 mg
Product Characteristics
ColorblueScoreno score
ShapeOVAL (Biconvex) Size12mm
FlavorImprint CodeI7
Contains    
Packaging
#Item CodePackage Description
1NDC:54868-5308-0100 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07909605/23/2005
Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIOperations
Physicians Total Care, Inc.194123980relabel

 
Physicians Total Care, Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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