IBUPROFEN - ibuprofen tablet, film coated 
Chain Drug Consortium LLC

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ACTIVE INGREDIENT(S)

Ibuprofen 200 mg (NSAID)*

·        nonsteroidal 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)

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

STORAGE

PRINCIPAL DISPLAY PANEL

Carton Label PDP

NDC# 68016-295-01

DYE FREE
Ibuprofen Tablets 200 mg

PAIN RELIEVER/FEVER REDUCER (NSAID)

SEE NEW WARNINGS INFORMATION

100 COATED TABLETS

Carton label - 100 count



Bottle Label PDP

NDC# 68016-295-01

DYE FREE
Ibuprofen Tablets 200 mg

PAIN RELIEVER/FEVER REDUCER (NSAID)

SEE NEW WARNINGS INFORMATION

100 COATED TABLETS


bottle-label-100ct


Carton Label PDP

NDC# 68016-295-50

DYE FREE
Ibuprofen Tablets 200 mg

PAIN RELIEVER/FEVER REDUCER (NSAID)

SEE NEW WARNINGS INFORMATION

50 COATED TABLETS

carton label-50 ct



Bottle Label PDP

NDC# 68016-295-50

DYE FREE
Ibuprofen Tablets 200 mg

PAIN RELIEVER/FEVER REDUCER (NSAID)

SEE NEW WARNINGS INFORMATION

50 COATED TABLETS


bottle-label-50 ct




IBUPROFEN 
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-295
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITEScoreno score
ShapeROUNDSize10mm
FlavorImprint Code 115
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-295-011 in 1 CARTON
1100 in 1 BOTTLE
2NDC:68016-295-501 in 1 CARTON
250 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09123705/07/2013
Labeler - Chain Drug Consortium LLC (101668460)
Registrant - Chain Drug Consortium LLC (101668460)
Establishment
NameAddressID/FEIBusiness Operations
Marksans Pharma Limited925822975MANUFACTURE(68016-295)

Revised: 4/2013
Document Id: 733d3671-2924-49d3-ad1d-c577a441ace8
Set id: 733d3671-2924-49d3-ad1d-c577a441ace8
Version: 1
Effective Time: 20130429
 
Chain Drug Consortium LLC