IBUPROFEN

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

ibuprofen tablets 400 mg — 600 mg- 800 mg medguide

MEDGUIDE IBUPROFEN TABLETS
(click image for full-size original)

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
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400 mg 500 count label

400 mg 500 count label
(click image for full-size original)

600 mg 100 count label

600 mg 100 count label
(click image for full-size original)

800 mg 100 count label

800 mg 100 count label
(click image for full-size original)

600 MG 500 COUNT LABEL

600 MG 500 CT LABEL
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800 MG 500 COUNT LABEL

800 MG 500 COUNT LABEL
(click image for full-size original)

IBUPROFEN
ibuprofen tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49483-602
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 400 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL
STARCH, PREGELATINIZED CORN
TALC
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape ROUND Size 13mm
Flavor Imprint Code 121
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49483-602-01 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:49483-602-50 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090796 12/30/2015
IBUPROFEN
ibuprofen tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49483-603
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 600 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL
STARCH, PREGELATINIZED CORN
TALC
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code 122
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49483-603-03 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:49483-603-05 50 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:49483-603-01 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:49483-603-50 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090796 12/30/2015
IBUPROFEN
ibuprofen tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49483-604
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 800 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL
STARCH, PREGELATINIZED CORN
TALC
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code 123
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49483-604-03 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:49483-604-05 50 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:49483-604-01 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:49483-604-50 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090796 12/30/2015
Labeler — TIME CAP LABORATORIES, INC (037052099)
Registrant — TIME CAP LABORATORIES, INC (037052099)
Establishment
Name Address ID/FEI Operations
MARKSANS PHARMA LIMITED 925822975 manufacture (49483-602), manufacture (49483-603), manufacture (49483-604)

Revised: 12/2019 TIME CAP LABORATORIES, INC

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