IBUPROFEN - ibuprofen tablet 
Discount Drug Mart

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ACTIVE INGREDIENT(S)

Ibuprofen 200 mg (NSAID)*

·        Non-steroidal 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

STORAGE

INACTIVE INGREDIENTS

Microcrystalline cellulose, Croscarmellose Sodium, Pregelatinized starch, Talc, Colloidal Silicon Dioxide, Magnesium stearate, polyethylene glycol, polyvinyl alcohol, titanium dioxide.

PRINCIPAL DISPLAY PANEL

Carton Label PDP

Drug mart
IBUPROFEN TABLETS, USP 200 mg
Pain Reliever/ Fever Reducer (NSAID)

100 COATED TABLETS

DDM-IBU-wht-carton



Bottle Label PDP

Drug mart

IBUPROFEN TABLETS, USP 200 mg
Pain Reliever/ Fever Reducer (NSAID)

100 COATED TABLETS

DDM-IBU-wht-bottle




IBUPROFEN 
ibuprofen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53943-115
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)  
COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize10mm
FlavorImprint Code 115
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53943-115-011 in 1 CARTON
1100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09123706/20/2013
Labeler - Discount Drug Mart (047741335)
Registrant - Discount Drug Mart (047741335)
Establishment
NameAddressID/FEIBusiness Operations
Marksans Pharma Limited925822975MANUFACTURE(53943-115)

Revised: 6/2013
Document Id: f5312ee8-5fef-4c62-af83-0f8ef81bdd53
Set id: f5312ee8-5fef-4c62-af83-0f8ef81bdd53
Version: 1
Effective Time: 20130618
 
Discount Drug Mart