IBUPROFEN tablet, film coated

Ibuprofen by

Drug Labeling and Warnings

Ibuprofen by is a Prescription medication manufactured, distributed, or labeled by Contract Pharmacy Services-PA, Coupler Enterprises Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PATIENT MEDICATION INFORMATION

TIME CAP LABORATORIES, INC TIME CAP LABORATORIES, INC MARKSANS PHARMA LIMITED IBUPROFEN IBUPROFEN IBUPROFEN IBUPROFEN COLLOIDAL SILICON DIOXIDE CROSCARMELLOSE SODIUM MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOLS POLYVINYL ALCOHOL STARCH, PREGELATINIZED CORN TALC TITANIUM DIOXIDE 121 IBUPROFEN IBUPROFEN IBUPROFEN IBUPROFEN COLLOIDAL SILICON DIOXIDE CROSCARMELLOSE SODIUM MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOLS POLYVINYL ALCOHOL STARCH, PREGELATINIZED CORN TALC TITANIUM DIOXIDE 122 IBUPROFEN IBUPROFEN IBUPROFEN IBUPROFEN COLLOIDAL SILICON DIOXIDE CROSCARMELLOSE SODIUM MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOLS POLYVINYL ALCOHOL STARCH, PREGELATINIZED CORN TALC TITANIUM DIOXIDE 123 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 400mg Ibuprofen Package Label image description 600mg Ibuprofen Package Label image description 800mg Ibuprofen Package Label image description ​REPACKAGED BY: COUPLER ENTERPRISES INC. NDJA 4/19/18

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

IBUPROFEN 
ibuprofen tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 67046-688(NDC:49483-603)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	600 mg

Product Characteristics
Color	white	Score	no score
Shape	CAPSULE	Size	18mm
Flavor		Imprint Code	122
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67046-688-30	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	02/15/2018
2	NDC: 67046-688-60	60 in 1 BLISTER PACK; Type 0: Not a Combination Product	02/15/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090796	02/15/2018

Labeler - Contract Pharmacy Services-PA (945429777)

Establishment
Name	Address	ID/FEI	Business Operations
Coupler Enterprises Inc.		945429777	repack(67046-688)