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Ibuprofen by Medline industries, Inc.

Medically reviewed on September 29, 2017

Dosage form: tablet
Ingredients: IBUPROFEN 200mg
Labeler: Medline industries, Inc.
NDC Code: 53329-674

DRUG FACTS

Active ingredient

Ibuprofen UPS, 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

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

Warnings

Allergy alert

Ibuprofen 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

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.

Ask a doctor before use if

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

Ask a doctor or pharmacist before use if

  • under a doctor's care for any serious condition
  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • 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
  • slurred speech
  • leg swelling
  • trouble breathing
  • 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

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen 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.(1-800-222-1222)

Directions

  • do not take more than directed
  • the smallest effective dose should be used
  • adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist
  • if pain or fever does not respond to 1 tablet, 2 tablets may be used
  • do not exceed 6 tablets in 24 hours, unless directed by a doctor
  • children under 12 years: ask a doctor

Other Information

store between 20° to 25°C (68° to 77°F). Avoid excessive heat above 40° (104°F).

Inactive Ingredients

colloidal silicon dioxide, corn starch, iron oxide red, macrogol/PEG, polyvinyl alcohol-part. hydrolyzed, povidone k-30, pregelatinized starch, sodium starch glycolate, stearic acid, talc, titanium dioxide

Questions

Questions or comments?

Call Toll Free 1-800-MEDLINE (633-5463) Monday-Friday 9am-5pm CST

Principal Display Panel

Medline

NDC 53329-674-30

IbuprofenTablets USP

Pain Reliever/

Fever Reducer (NSAID)

200 mg

100 coated tablets - 200 mg each

IBUPROFEN 
ibuprofen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-674
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
STARCH, CORN 
FERRIC OXIDE RED 
POVIDONE K30 
SODIUM STARCH GLYCOLATE TYPE A CORN 
STEARIC ACID 
TITANIUM DIOXIDE 
TALC 
POLYVINYL ALCOHOL, UNSPECIFIED 
POLYETHYLENE GLYCOL, UNSPECIFIED 
Product Characteristics
ColorbrownScorescore with uneven pieces
ShapeROUNDSize10mm
FlavorImprint CodeG2
Contains    
Packaging
#Item CodePackage Description
1NDC:53329-674-301 BOTTLE in 1 CARTON
1100 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07917409/29/2017
Labeler - Medline industries, Inc. (025460908)

 
Medline industries, 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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