GIALAX- polyethylene glycol 3350 kit

GIALAX by

Drug Labeling and Warnings

GIALAX by is a Prescription medication manufactured, distributed, or labeled by Phlight Pharma, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PATIENT PACKAGE INSERT

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GIALAX 
polyethylene glycol 3350 kit

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70569-840

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70569-840-01	1 in 1 CARTON; Type 1: Convenience Kit of Co-Package	05/19/2016

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	527 g
Part 2	1 PACKET	3 g  in 3

Part 1 of 2

POLYETHYLENE GLYCOL 3350 
polyethylene glycol 3350 powder, for solution

Product Information
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P)	POLYETHYLENE GLYCOL 3350	1 g  in 1 g

Product Characteristics
Color	white (White to Off-White)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		527 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076652	10/01/2011

Part 2 of 2

ALL SPORT MIX 
sport drink mix powder, for solution

Product Information
Route of Administration	ORAL

Inactive Ingredients
Ingredient Name	Strength
ASCORBIC ACID (UNII: PQ6CK8PD0R)
XANTHAN GUM (UNII: TTV12P4NEE)
PIGMENT BLUE 1 (UNII: 4SBE571RQF)
ASPARTAME (UNII: Z0H242BBR1)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
CALCIUM SILICATE (UNII: S4255P4G5M)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
MONOPOTASSIUM PHOSPHITE (UNII: 59RSS63D8J)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Product Characteristics
Color		Score
Shape		Size
Flavor	BLUEBERRY ("Blue Raz")	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		3 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
DIETARY SUPPLEMENT

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/01/2011

Labeler - Phlight Pharma, LLC (080168751)

Registrant - Phlight Pharma, LLC (080168751)

Establishment
Name	Address	ID/FEI	Business Operations
Phlight Pharma, LLC		080168751	label(70569-840)