IBUPROFEN- ibuprofen tablet, film coated 
REMEDYREPACK INC.

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IBUPROFEN 400 MG - 600 MG AND 800 MG TABLETS

ibuprofen tablets 400 mg - 600 mg- 800 mg medguide

MEDGUIDE IBUPROFEN TABLETS

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

800 mg (white to off-white, capsule shaped, biconvex, film-coated​ tablets debossed with ‘123’ on one side and plain on other side)

PRINCIPAL DISPLAY PANEL

DRUG: IBUPROFEN

GENERIC: IBUPROFEN

DOSAGE: TABLET, FILM COATED

ADMINSTRATION: ORAL

NDC: 70518-0005-0

NDC: 70518-0005-1

NDC: 70518-0005-2

NDC: 70518-0005-3

NDC: 70518-0005-4

NDC: 70518-0005-5

COLOR: white

SHAPE: CAPSULE

SCORE: No score

SIZE: 19 mm

IMPRINT: 123

PACKAGING: 21 in 1 BLISTER PACK

PACKAGING: 14 in 1 BLISTER PACK

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 10 in 1 BLISTER PACK

PACKAGING: 90 in 1 BOTTLE PLASTIC

PACKAGING: 30 in 1 BOTTLE PLASTIC

ACTIVE INGREDIENT(S):

  • IBUPROFEN 800mg in 1

INACTIVE INGREDIENT(S):

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

Remedy_Label

MM2

MM3

MM4

MM5

MM6

IBUPROFEN 
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70518-0005(NDC:49483-604)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN800 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
ShapeCAPSULESize19mm
FlavorImprint Code 123
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70518-0005-021 in 1 BLISTER PACK; Type 0: Not a Combination Product11/17/201606/04/2019
2NDC:70518-0005-114 in 1 BLISTER PACK; Type 0: Not a Combination Product12/05/201606/01/2019
3NDC:70518-0005-230 in 1 BLISTER PACK; Type 0: Not a Combination Product12/13/201605/11/2019
4NDC:70518-0005-310 in 1 BLISTER PACK; Type 0: Not a Combination Product01/27/201706/11/2019
5NDC:70518-0005-490 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/06/201707/12/2019
6NDC:70518-0005-530 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/04/201706/28/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09079611/17/201607/12/2019
Labeler - REMEDYREPACK INC. (829572556)

Revised: 3/2020
 
REMEDYREPACK INC.