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 Type HUMAN OTC DRUG Item Code (Source) NDC:25000-115
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 10mm
Flavor Imprint Code 115
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:25000-115-03 30 in 1 BOTTLE
2 NDC:25000-115-14 1000 in 1 BOTTLE
3 NDC:25000-115-30 6 in 1 BOX
3 6500 in 1 BAG
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091237 07/04/2012
IBUPROFEN 
ibuprofen tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:25000-120
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 15mm
Flavor Imprint Code 120
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:25000-120-03 30 in 1 BOTTLE
2 NDC:25000-120-14 1000 in 1 BOTTLE
3 NDC:25000-120-30 6 in 1 BOX
3 6500 in 1 BAG
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091237 07/04/2012
Labeler - MARKSANS PHARMA LIMITED (925822975)
Establishment
Name Address ID/FEI Business Operations
MARKSANS PHARMA LIMITED 925822975 MANUFACTURE(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