IBUPROFEN- ibuprofen tablet, film coated 
TIME CAP LABORATORIES, 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)

400mg Ibuprofen 100 count label

400 mg label

400 mg 500 count label

400 mg 500 count label

600 mg 100 count label

600 mg 100 count label

800 mg 100 count label

800 mg 100 count label

600 MG 500 COUNT LABEL

600 MG 500 CT LABEL

800 MG 500 COUNT LABEL

800 MG 500 COUNT LABEL

IBUPROFEN 
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)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:49483-602-01100 in 1 BOTTLE; Type 0: Not a Combination Product12/30/2015
2NDC:49483-602-50500 in 1 BOTTLE; Type 0: Not a Combination Product12/30/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09079612/30/2015
IBUPROFEN 
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)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:49483-603-0330 in 1 BOTTLE; Type 0: Not a Combination Product12/30/2015
2NDC:49483-603-0550 in 1 BOTTLE; Type 0: Not a Combination Product12/30/2015
3NDC:49483-603-01100 in 1 BOTTLE; Type 0: Not a Combination Product12/30/2015
4NDC:49483-603-50500 in 1 BOTTLE; Type 0: Not a Combination Product12/30/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09079612/30/2015
IBUPROFEN 
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)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:49483-604-0330 in 1 BOTTLE; Type 0: Not a Combination Product12/30/2015
2NDC:49483-604-0550 in 1 BOTTLE; Type 0: Not a Combination Product12/30/2015
3NDC:49483-604-01100 in 1 BOTTLE; Type 0: Not a Combination Product12/30/2015
4NDC:49483-604-50500 in 1 BOTTLE; Type 0: Not a Combination Product12/30/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09079612/30/2015
Labeler - TIME CAP LABORATORIES, INC (037052099)
Registrant - TIME CAP LABORATORIES, INC (037052099)
Establishment
NameAddressID/FEIBusiness Operations
MARKSANS PHARMA LIMITED925822975manufacture(49483-602, 49483-603, 49483-604)

Revised: 12/2019
Document Id: 9af0c38e-0340-926c-e053-2995a90a30c8
Set id: ec3e8443-d742-4c25-8516-f0df4ebfccdc
Version: 7
Effective Time: 20191230
 
TIME CAP LABORATORIES, INC