Medique Mediproxen

Dosage form: tablet, film coated
Ingredients: NAPROXEN SODIUM 220mg
Labeler: Unifirst First Aid Corporation
NDC Code: 47682-237

237R UniFirst 47682 Medique Mediproxen Amneal

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 stomach ulcers or bleeding problems
  • take a blood thinner (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 ever have had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery

Ask a doctor before use if
  • 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
  • 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 for more than 10 days
  • fever gets worse or lasts for 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 accidental 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: (12 years of age 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 or 3 tablets in a 24 hour period.

Children under 12 years:   Do not give to children under 12 years of age.

Other information
  • each tablet contains: 20 mg of Sodium
  • store at room temperature 68-77ºF (20-25ºC)
  • avoid high humidity and excessive heat above 104ºF (40ºC)
  • tamper evident sealed packets
  • do not use any open or torn packets

Inactive ingredients

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

Questions or comments? 1-800-634-7680

237R Medique Mediproxen Label

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Mediproxen

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Naproxen Sodium (NSAID),

Pain Reliever/Fever Reducer

Pull to Open

Easy to Swallow

Film Coated Tablets

100 Tablets

(100 x 1)

Tamper Evident Unit Dose Packets

MEDIQUE MEDIPROXEN 
naproxen sodium tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-237
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 
MAGNESIUM STEARATE 
POLYETHYLENE GLYCOL 
POLYVINYL ALCOHOL 
POVIDONE 
STARCH, CORN 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
Colorblue (blue) Scoreno score
ShapeROUND (ROUND) Size9mm
FlavorImprint CodeI;3
Contains    
Packaging
#Item CodePackage Description
1NDC:47682-237-5050 PACKET (50 PACKET) in 1 BOX, UNIT-DOSE
1NDC:47682-237-461 TABLET, FILM COATED (1 TABLET) in 1 PACKET
2NDC:47682-237-33100 PACKET (100 PACKET) in 1 BOX, UNIT-DOSE
2NDC:47682-237-461 TABLET, FILM COATED (1 TABLET) in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07909612/30/2008
Labeler - Unifirst First Aid Corporation (832947092)

Revised: 12/2010
 
Unifirst First Aid Corporation

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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