IBUPROFEN tablet, film coated

IBUPROFEN by

Drug Labeling and Warnings

IBUPROFEN by is a Prescription medication manufactured, distributed, or labeled by NuCare Pharmaceuticals,Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HOW SUPPLIED

NDC: 68071-3362-0 Bottles of 12

NDC: 68071-3362-5 Bottles of 15

NDC: 68071-3362-2 Bottles of 20

NDC: 68071-3362-2 Bottles of 21

NDC: 68071-3362-3 Bottles of 30

NDC: 68071-3362-4 Bottles of 40

NDC: 68071-3362-6 Bottles of 60

NDC: 68071-3362-9 Bottles of 90

800mg Ibuprofen Package Label

INGREDIENTS AND APPEARANCE

IBUPROFEN 
ibuprofen tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 68071-3362(NDC:49483-604)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	800 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score	no score
Shape	CAPSULE	Size	19mm
Flavor		Imprint Code	123
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68071-3362-5	15 in 1 BOTTLE; Type 0: Not a Combination Product	07/26/2017
2	NDC: 68071-3362-0	12 in 1 BOTTLE; Type 0: Not a Combination Product	07/26/2017
3	NDC: 68071-3362-2	20 in 1 BOTTLE; Type 0: Not a Combination Product	07/26/2017
4	NDC: 68071-3362-1	21 in 1 BOTTLE; Type 0: Not a Combination Product	07/26/2017
5	NDC: 68071-3362-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	07/26/2017
6	NDC: 68071-3362-4	40 in 1 BOTTLE; Type 0: Not a Combination Product	07/26/2017
7	NDC: 68071-3362-6	60 in 1 BOTTLE; Type 0: Not a Combination Product	07/26/2017
8	NDC: 68071-3362-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	07/26/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090796	12/30/2015

Labeler - NuCare Pharmaceuticals,Inc. (010632300)

Establishment
Name	Address	ID/FEI	Business Operations
NuCare Pharmaceuticals,Inc.		010632300	repack(68071-3362)