IBUPROFEN - ibuprofen tablet, coated 
Weeks & Leo Co., Inc.

----------

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 Poison Control Center right away. (1-800-222-1222)

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

colloidal silicon dioxide, croscarmellose sodium, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinised starch, talc, titanium dioxide.

PRINCIPAL DISPLAY PANEL

Carton Label PDP

Ibuprofen 200mg CAPLET

PAIN RELIEVER/ FEVER REDUCER (NSAID)

ibubr cap



Ibu-cap-br


Ibu-cap-br


Ibu-cap-br


ibu-cap-br


IBUPROFEN 
ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11383-151
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
STARCH, CORN (UNII: O8232NY3SJ)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
Product Characteristics
ColorBROWNScoreno score
ShapeCAPSULESize15mm
FlavorImprint Code 117
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11383-151-501 in 1 CARTON
150 in 1 BOTTLE
2NDC:11383-151-111 in 1 CARTON
2100 in 1 BOTTLE
3NDC:11383-151-211 in 1 CARTON
3200 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09123905/17/2013
Labeler - Weeks & Leo Co., Inc. (005290028)
Registrant - Weeks & Leo Co., Inc. (005290028)
Establishment
NameAddressID/FEIBusiness Operations
Marksans Pharma Limited925822975MANUFACTURE(11383-151)

Revised: 5/2013
Document Id: 70453c76-7f71-4edb-9c67-3741dc21d1d1
Set id: 70453c76-7f71-4edb-9c67-3741dc21d1d1
Version: 1
Effective Time: 20130517
 
Weeks & Leo Co., Inc.