IBUPROFEN - ibuprofen tablet, film coated 
Major Pharmaceuticals

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DRUG FACTS

ACTIVE INGREDIENT

(in each white tablet)

Ibuprofen USP, 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

PURPOSE

Pain reliever/fever reducer

USES

WARNINGS SECTION

 SEE NEW WARNINGS INFORMATION

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 perscription or nonperscription 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

  • 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 or asthma 
  • 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 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
  • 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
  • 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.

DIRECTIONS

 Do not take more than directed

The smallest effective dose must 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

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed
  • the smallest effective dose should be used
  • do not take longer than 10 days, unless directed by a doctor (see WARNINGS )
  • 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

INACTIVE INGREDIENTS

 

cellulose, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, polyethylene glycol, povidone, sodium starch glycolate, stearic acid, triacetin

Questions or comments?

call 1-800-616-2471

PRINCIPAL DISPLAY PANEL

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

Major Pharmaceuticals

Ibuprofen Tablets USP, 200 mg

Pain Reliever / Fever Reducer (NSAID)

100 Film Coated Tablets Color Free - Dye Free

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

Distributed by:    Major Pharmaceuticals, Livonia, MI 48150  USA

Ibuprofen 200 mg Tablets


IBUPROFEN 
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-7914
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
HYPROMELLOSES 
LACTOSE 
MAGNESIUM STEARATE 
POLYDEXTROSE 
POLYETHYLENE GLYCOLS 
POVIDONE 
STEARIC ACID 
TRIACETIN 
Product Characteristics
ColorWHITEScore no score
ShapeROUNDSize10mm
FlavorImprint Code 44438
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:0904-7914-591 BOTTLE, PLASTIC (1 BOTTLE) in 1 CARTONcontains a BOTTLE, PLASTIC
1100 TABLET, FILM COATED (100 TABLET) in 1 BOTTLE, PLASTICThis package is contained within the CARTON (0904-7914-59)
2NDC:0904-7914-5150 BOTTLE, PLASTIC (50 TABLET) in 1 CARTONcontains a BOTTLE, PLASTIC
250 TABLET, FILM COATED (50 TABLET) in 1 BOTTLE, PLASTICThis package is contained within the CARTON (0904-7914-51)
3NDC:0904-7914-61100 TABLET, FILM COATED (100 TABLET) in 1 BOX, UNIT-DOSENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07513911/06/2007

Labeler - Major Pharmaceuticals (191427277)

Revised: 08/2012 Major Pharmaceuticals