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

DRUG: IBUPROFEN

GENERIC: IBUPROFEN

DOSAGE: TABLET, FILM COATED

ADMINSTRATION: ORAL

NDC: 61786-947-02

COLOR: white

SHAPE: ROUND

SCORE: No score

SIZE: 13 mm

IMPRINT: 121

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • IBUPROFEN 400mg 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

IBUPROFEN 
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:61786-947(NDC:49483-602)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN400 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
ShapeROUNDSize13mm
FlavorImprint Code 121
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61786-947-0230 in 1 BLISTER PACK; Type 0: Not a Combination Product10/19/201604/23/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09079610/19/201604/23/2018
Labeler - REMEDYREPACK INC. (829572556)

Revised: 1/2020
Document Id: 7bd5c3b3-fdfb-f29a-e053-2a91aa0aa9ae
Set id: 88dd9ae0-f93c-4f8e-9d96-49776144a834
Version: 2
Effective Time: 20200128
 
REMEDYREPACK INC.