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: 70518-2432-0

COLOR: white

SHAPE: ROUND

SCORE: No score

SIZE: 13 mm

IMPRINT: 121

PACKAGING: 21 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

INACTIVE INGREDIENT(S):

Remedy_Label

IBUPROFEN 
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70518-2432(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:70518-2432-021 in 1 BLISTER PACK; Type 0: Not a Combination Product11/18/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09079611/18/2019
Labeler - REMEDYREPACK INC. (829572556)

Revised: 11/2019
Document Id: 97abd3c0-c77d-9140-e053-2a95a90a788b
Set id: a7756b22-73cf-4262-aa8e-0577ddecd03b
Version: 1
Effective Time: 20191118
 
REMEDYREPACK INC.