IBUPROFEN- ibuprofen tablet, film coated
A-S Medication Solutions

----------

IBUPROFEN 400 MG - 600 MG AND 800 MG TABLETS

ibuprofen tablets 400 mg - 600 mg- 800 mg medguide

MEDGUIDE IBUPROFEN TABLETS

HOW SUPPLIED

Product: 50090-5160

NDC: 50090-5160-0 16 TABLET, FILM COATED in a BOTTLE

IBUPROFEN TABLET, FILM COATED

Label Image

IBUPROFEN
ibuprofen tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:50090-5160(NDC:49483-602)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	400 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	13mm
Flavor		Imprint Code	121
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50090-5160-4	20 in 1 BOTTLE; Type 0: Not a Combination Product	09/21/2020	01/31/2023
2	NDC:50090-5160-0	16 in 1 BOTTLE; Type 0: Not a Combination Product	09/21/2020
3	NDC:50090-5160-3	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/21/2020	09/30/2022
4	NDC:50090-5160-1	30 in 1 BOTTLE; Type 0: Not a Combination Product	09/21/2020	09/30/2022
5	NDC:50090-5160-8	60 in 1 BOTTLE; Type 0: Not a Combination Product	09/21/2020	04/30/2022

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

Labeler - A-S Medication Solutions (830016429)

Name	Address	ID/FEI	Business Operations
Establishment
A-S Medication Solutions		830016429	RELABEL(50090-5160) , REPACK(50090-5160)

Revised: 2/2023

Document Id: 9f5574a1-bd50-4db0-8a05-8d3968825ca0

Set id: 1d1a6120-068b-4863-a85a-8ac9e433fcb3

Version: 7

Effective Time: 20230206

A-S Medication Solutions