IBUPROFEN  - ibuprofen tablet 
MARKSANS PHARMA LIMITED

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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 DRUGItem 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
ColorWHITEScore no score
ShapeROUNDSize10mm
FlavorImprint Code 115
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:25000-115-0330 TABLET (30 TABLET) in 1 BOTTLENone
2NDC:25000-115-141000 TABLET (1000 TABLET) in 1 BOTTLENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09123707/04/2012

IBUPROFEN 
ibuprofen tablet
Product Information
Product TypeHUMAN OTC DRUGItem 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
ColorWHITEScore no score
ShapeCAPSULESize15mm
FlavorImprint Code 120
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:25000-120-0330 TABLET (30 TABLET) in 1 BOTTLENone
2NDC:25000-120-141000 TABLET (1000 TABLET) in 1 BOTTLENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09123707/04/2012

Labeler - MARKSANS PHARMA LIMITED (925822975)
Establishment
NameAddressID/FEIOperations
MARKSANS PHARMA LIMITED925822975MANUFACTURE

Revised: 07/2012 MARKSANS PHARMA LIMITED