IBUPROFEN- ibuprofen tablet, film coated 
REMEDYREPACK INC.

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HOW SUPPLIED

400mg (white to of white, round, biconvex, film coated tablets debossed with '121' on one side and plain on the other side) Bottles of 100 & 500

HOW SUPPLIED

600mg (white to off white, capsule shaped, biconvex, film coated tablets debossed with '122' on one side and plain on the other side) Bottles of 30, 50, 100 & 500

800mg (white to off white, capsule shaped, biconvex, film coated tablets debossed with '123' on one side and plain on the other side) Bottles of 30, 50, 100 & 500

PRINCIPAL DISPLAY PANEL

MM5DRUG: IBUPROFEN

GENERIC: IBUPROFEN

DOSAGE: TABLET, FILM COATED

ADMINSTRATION: ORAL

NDC: 61786-953-03

NDC: 61786-953-02

NDC: 61786-953-05

NDC: 61786-953-06

NDC: 61786-953-15

COLOR: white

SHAPE: CAPSULE

SCORE: No score

SIZE: 18 mm

IMPRINT: 122

PACKAGING: 20 in 1 BLISTER PACK

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 21 in 1 BLISTER PACK

PACKAGING: 28 in 1 BLISTER PACK

PACKAGING: 15 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • IBUPROFEN 600mg in 1

INACTIVE INGREDIENT(S):

  • COLLOIDAL SILICON DIOXIDE
  • STARCH, PREGELATINIZED CORN
  • POLYVINYL ALCOHOL
  • TALC
  • POLYETHYLENE GLYCOLS
  • CELLULOSE, MICROCRYSTALLINE
  • CROSCARMELLOSE SODIUM
  • MAGNESIUM STEARATE
  • TITANIUM DIOXIDE

Remedy_Label

MM2

MM3

MM4

MM6

IBUPROFEN 
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:61786-953(NDC:49483-603)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN600 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULESize18mm
FlavorImprint Code 122
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61786-953-0320 in 1 BLISTER PACK; Type 0: Not a Combination Product10/24/201606/21/2018
2NDC:61786-953-0230 in 1 BLISTER PACK; Type 0: Not a Combination Product10/24/201606/27/2018
3NDC:61786-953-0521 in 1 BLISTER PACK; Type 0: Not a Combination Product10/24/201607/06/2018
4NDC:61786-953-0628 in 1 BLISTER PACK; Type 0: Not a Combination Product10/24/201607/16/2018
5NDC:61786-953-0810 in 1 BLISTER PACK; Type 0: Not a Combination Product10/24/201601/09/2018
6NDC:61786-953-1515 in 1 BLISTER PACK; Type 0: Not a Combination Product10/24/201607/10/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09079610/24/201607/16/2018
Labeler - REMEDYREPACK INC. (829572556)

Revised: 11/2018
Document Id: 7bd6cf75-ab41-f61a-e053-2991aa0a4486
Set id: 28535587-b6d6-4f0f-a77d-4f0eca0ba8f1
Version: 7
Effective Time: 20181129
 
REMEDYREPACK INC.