COMPRESSO GGF 95 SA by Granules India Limited COMPRESSO GGF 95 SA

COMPRESSO GGF 95 SA by

Drug Labeling and Warnings

COMPRESSO GGF 95 SA by is a Other medication manufactured, distributed, or labeled by Granules India Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

COMPRESSO GGF 95 SA- guaifenesin directly compressible granules 95% powder 
Granules India Limited

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COMPRESSO GGF 95 SA

COMPRESSO GGF 95 SA 
guaifenesin directly compressible granules 95% powder

Product Information
Product Type	BULK INGREDIENT	Item Code (Source)	NDC: 62207-503
Route of Administration	NOT APPLICABLE

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	95 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
POVIDONE K30 (UNII: U725QWY32X)

Product Characteristics
Color	white (White free flowing granular powder)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62207-503-13	50000000 mg in 1 DRUM	05/04/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		05/04/2012

COMPRESSO GGF 95 SA 
guaifenesin directly compressible granules 95% powder

Product Information
Product Type	BULK INGREDIENT	Item Code (Source)	NDC: 62207-500
Route of Administration	NOT APPLICABLE

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	95 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
POVIDONE K30 (UNII: U725QWY32X)

Product Characteristics
Color	white (White free flowing granular powder)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62207-500-04	50000000 mg in 1 DRUM	08/17/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		08/17/2017

Labeler - Granules India Limited (915000087)

Establishment
Name	Address	ID/FEI	Business Operations
Granules India Limited		918609236	analysis(62207-503, 62207-500) , label(62207-503, 62207-500) , manufacture(62207-503, 62207-500) , pack(62207-503, 62207-500)

Revised: 2/2023

Document Id: f4e571a4-3018-0585-e053-2a95a90a88c5

53409-9

Set id: 4a4da6a2-9318-04d0-e054-00144ff8d46c

Version: 6

Effective Time: 20230217