IBUPROFEN- ibuprofen tablet, film coated 
Major Pharmaceuticals

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Ibuprofen Tablets USP, 200 mg

DRUG FACTS

ACTIVE INGREDIENT

(in each white tablet)

Ibuprofen USP, 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

PURPOSE

Pain reliever/fever reducer

USES

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

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.  (1-800-222-1222)

DIRECTIONS

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

DOSAGE & ADMINISTRATION SECTION

  • 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 Do Not Use

OTHER INFORMATION

Read all warnings and directions before use.  Store at 20-25ºC (68º-77ºF); excursions permitted to 15º-30ºC (59º-86ºF).  [See USP Controlled Room Temperature].

INACTIVE INGREDIENTS

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

Questions or comments?

(800) 616-2471

Distributed by:

MAJOR® PHARMACEUTICALS

31778 Enterprise Drive

Livonia, MI  48150 USA

Re-Order No. 301559

PRINCIPAL DISPLAY PANEL IBUPROFEN TABLETS, USP 200MG

 IBUPROFEN TABLETS, USP 200MG

IBUPROFEN 
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0904-7914(NDC:50844-438)
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 
POVIDONES 
STEARIC ACID 
TRIACETIN 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize10mm
FlavorImprint Code 44438
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-7914-61100 in 1 BOX, UNIT-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07513911/06/2007
Labeler - Major Pharmaceuticals (191427277)

Revised: 8/2012
 
Major Pharmaceuticals