IBUPROFEN - ibuprofen tablet 
MARKSANS PHARMA LIMITED

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Ibuprofen Tablets 200mg (White-Round and Caplet) 

Active ingredient(s)


Ibuprofen 200 mg (NSAID)*

·        nonstreoidal anti-inflammatory drug

Purpose


Pain reliever / fever reducer

Use(s)


Warnings


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

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:

Do not use


Ask a doctor before use if


 you have

Ask a doctor or pharmacist before use if


you are

When using this product


Stop use and ask doctor if


        These are signs of stomach bleeding.

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


         
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


 

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
Document Id: 7cb4f325-b9a8-4f42-b585-a51ac2d33dda
Set id: a991ef53-a633-476a-bb7c-1479aef2eb3b
Version: 4
Effective Time: 20121130
 
MARKSANS PHARMA LIMITED