IBUPROFEN by REMEDYREPACK INC.

IBUPROFEN by

Drug Labeling and Warnings

IBUPROFEN by is a Prescription medication manufactured, distributed, or labeled by REMEDYREPACK INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

IBUPROFEN- ibuprofen tablet, film coated 
REMEDYREPACK INC.

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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

PRINCIPAL DISPLAY PANEL

DRUG: IBUPROFEN

GENERIC: IBUPROFEN

DOSAGE: TABLET, FILM COATED

ADMINSTRATION: ORAL

NDC: 61786-947-02

COLOR: white

SHAPE: ROUND

SCORE: No score

SIZE: 13 mm

IMPRINT: 121

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

• IBUPROFEN 400mg in 1

INACTIVE INGREDIENT(S):

• COLLOIDAL SILICON DIOXIDE
• STARCH, PREGELATINIZED CORN
• POLYVINYL ALCOHOL
• TALC
• POLYETHYLENE GLYCOLS
• CELLULOSE, MICROCRYSTALLINE
• CROSCARMELLOSE SODIUM
• MAGNESIUM STEARATE
• TITANIUM DIOXIDE

IBUPROFEN 
ibuprofen tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 61786-947(NDC: 49483-602)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	400 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	ROUND	Size	13mm
Flavor		Imprint Code	121
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61786-947-02	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	10/19/2016	04/23/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090796	10/19/2016	04/23/2018

Labeler - REMEDYREPACK INC. (829572556)

Revised: 1/2020

Document Id: 7bd5c3b3-fdfb-f29a-e053-2a91aa0aa9ae

34391-3

Set id: 88dd9ae0-f93c-4f8e-9d96-49776144a834

Version: 2

Effective Time: 20200128