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RxNorm Names

IBUPROFEN tablet
[MARKSANS PHARMA LIMITED]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL Abbreviated New Drug Application
Drug Label Sections

Active ingredient(s)


Ibuprofen 200 mg (NSAID)*

·        nonstreoidal anti-inflammatory drug

Purpose


Pain reliever / fever reducer

Use(s)


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

Warnings


Allergy alerts: Ibuprofen may cause a severe allergy reaction, especially in people allergic to aspirin.
Symptoms may include: 

  • asthma (wheezing)
  • blisters
  • facial swelling
  • hives
  • rash
  • shock
  • skin reddening

If an allergic reaction occurs, stop use and seek medical help right away.
Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if you:

  • are age 60 or older
  • have bad stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drug containing prescription NSAID (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks every day while using this product
  • the 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


 you have

  • problems or serious side effects from taking pain relievers or fever reducers
  • stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain
  • ulcers
  • bleeding problems
  • high blood pressure
  • heart or kidney disease
  • taken a diuretics
  • reached age 60 or older

Ask a doctor or pharmacist before use if


you are

  • taking any other drugs containg an NSAID (prescription or nonprescription)
  • taking a blood thining (anticoagulant) or steriod drug
  • under a doctor’s care for any serious condition
  • taking aspirin for heart attacks 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
  • long term continuous use may increase the risk of heart attack or stroke

Stop use and ask doctor if


  • you feel faint, vomit blood, or have bloody or black stools.

        These are signs of stomach bleeding.

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • stomach pain or upset gets worse or lasts
  • redness or swelling is present in painful area
  • any new symptoms appear

Pregnancy/Breastfeeding


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 a 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 PoisonControlCenter right away.

Directions

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

         
adults and children 12 years and older
  • 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

 
 
 

Inactive ingredient(s)


Microcrystalline sodium, Crosscarmellose Sodium, Pregelatinised starch, talc, Colloidal silicon dioxide, Magnesium stearate.

Storage

  • store between 20-25 0c (68-77 0 F).
  • do not use if seal under bottle cap imprinted with” SEALED for YOUR PROTECTION” is broken or missing.

 

Manufactured for:


Marksans Pharma Inc.

3-Phillips Ln,
Lake Grove, NY 11755, USA

Manufactured by:

Marksans Pharma Ltd.


Plot No. L-82, L-83, Verna Indl. Estate,
Verna, Goa-403 722, India. 

Principal Display Panel

1000's count coated Tablets:

Ibuprofen Tablets, USP 200mg


(Round Shape)
 
Ibuprofen round shape

 

1000's count coated Tablets:

Ibuprofen Tablets, USP 200mg


(Caplet Shape)
 

Ibuprofen capsule shape

 
 
  
 
 
 
 
 
IBUPROFEN 
ibuprofen tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:25000-115
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
CROSCARMELLOSE SODIUM 
STARCH, CORN 
TALC 
COLLOIDAL SILICON DIOXIDE 
MAGNESIUM STEARATE 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize10mm
FlavorImprint Code 115
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:25000-115-0330 in 1 BOTTLE
2NDC:25000-115-141000 in 1 BOTTLE
3NDC:25000-115-306 in 1 BOX
36500 in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09123707/04/2012
IBUPROFEN 
ibuprofen tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:25000-120
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
CROSCARMELLOSE SODIUM 
STARCH, CORN 
TALC 
COLLOIDAL SILICON DIOXIDE 
MAGNESIUM STEARATE 
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULESize15mm
FlavorImprint Code 120
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:25000-120-0330 in 1 BOTTLE
2NDC:25000-120-141000 in 1 BOTTLE
3NDC:25000-120-306 in 1 BOX
36500 in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09123707/04/2012
Labeler - MARKSANS PHARMA LIMITED (925822975)
Establishment
NameAddressID/FEIBusiness Operations
MARKSANS PHARMA LIMITED925822975MANUFACTURE(25000-115, 25000-120)

Revised: 11/2012
 
MARKSANS PHARMA LIMITED

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