COMPRESSO IBU 66- ibuprofen directly compressible granules 66% powder

COMPRESSO IBU 66 by

Drug Labeling and Warnings

COMPRESSO IBU 66 by is a Other medication manufactured, distributed, or labeled by Granules India Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COMPRESSO IBU 66 
ibuprofen directly compressible granules 66% powder

Product Information
Product Type	BULK INGREDIENT	Item Code (Source)	NDC: 62207-300
Route of Administration	NOT APPLICABLE

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	66 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
POVIDONE K30 (UNII: U725QWY32X)
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

Product Characteristics
Color	white (White free flowing granules with characteristic odor.)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62207-300-13	50000000 mg in 1 DRUM	02/16/2011
2	NDC: 62207-300-04	50000000 mg in 1 DRUM	02/16/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		02/16/2011

Labeler - Granules India Limited (915000087)

Establishment
Name	Address	ID/FEI	Business Operations
Granules India Limited		918609236	analysis(62207-300) , label(62207-300) , manufacture(62207-300) , pack(62207-300)