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Naproxen Sodium by Family Dollar (FAMILY WELLNESS)

Medically reviewed on March 26, 2018

Dosage form: tablet
Ingredients: NAPROXEN SODIUM 220mg
Labeler: Family Dollar (FAMILY WELLNESS)
NDC Code: 55319-169

Drug Facts

Active ingredient (in each tablet)

Naproxen sodium, USP 220 mg

(naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

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

Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke.These can be fatal. The risk is higher if you use more than directed or for longer 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
  • the stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease, asthma or had a stroke
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • you are taking a diuretic

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

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
  • you have symptoms of heart problems or stroke:
    • chest pain
    • trouble breathing
    • slurred speech
    • leg swelling
    • weakness in one part or side of body
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present in the painful area
  • any new symptoms appear
  • you have difficulty swallowing
  • it feels like the pill is struck in your throat

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 20º to 25ºC (68º to 77ºF). Avoid high humidity and excessive heat above 40°C (104°F).
  • read all warnings and directions before use. Keep carton.

Inactive ingredients

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

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM - 5PM EST

Principal Display Panel

COMPARE TO THE ACTIVE INGREDIENT OF ALEVE®†

SEE NEW WARNINGS

STRENGTH TO LAST 12 HOURS

All Day Pain Relief

Naproxen Sodium Tablets, 220 mg

Pain Reliever/ Fever Reducer (NSAID)

TABLETS

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

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY: MIDWOOD BRANDS, LLC

10611 MONROE RD., MATTHEWS, NC 28105

Product Label

FAMILY WELLNESS All Day Pain Relief

NAPROXEN SODIUM 
naproxen sodium tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-169
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPROXEN SODIUM (NAPROXEN) NAPROXEN SODIUM220 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
FD&C BLUE NO. 2 
POLYETHYLENE GLYCOLS 
MAGNESIUM STEARATE 
POLYVINYL ALCOHOL, UNSPECIFIED 
POVIDONE 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorBLUEScoreno score
ShapeROUNDSize10mm
FlavorImprint CodeI3
Contains    
Packaging
#Item CodePackage Description
1NDC:55319-169-011 BOTTLE in 1 BOX
1100 TABLET in 1 BOTTLE
2NDC:55319-169-501 BOTTLE, PLASTIC in 1 BOX
250 TABLET in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07909611/01/2013
Labeler - Family Dollar (FAMILY WELLNESS) (024472631)

 
Family Dollar (FAMILY WELLNESS)

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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