GIALAX- polyethylene glycol 3350 
Phlight Pharma, LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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GIALAX

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GIALAX layout

GIALAX 
polyethylene glycol 3350 kit
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70569-840
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70569-840-011 in 1 CARTON; Type 1: Convenience Kit of Co-Package05/19/2016
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 527 g
Part 21 PACKET 3 g  in 3 
Part 1 of 2
POLYETHYLENE GLYCOL 3350 
polyethylene glycol 3350 powder, for solution
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P) POLYETHYLENE GLYCOL 33501 g  in 1 g
Product Characteristics
Colorwhite (White to Off-White) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1527 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07665210/01/2011
Part 2 of 2
ALL SPORT MIX 
sport drink mix powder, for solution
Product Information
Route of AdministrationORAL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorBLUEBERRY ("Blue Raz") Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
13 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
DIETARY SUPPLEMENT
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/01/2011
Labeler - Phlight Pharma, LLC (080168751)
Registrant - Phlight Pharma, LLC (080168751)
Establishment
NameAddressID/FEIBusiness Operations
Phlight Pharma, LLC080168751label(70569-840)

Revised: 12/2018
Document Id: 7d4f7ed4-f456-562f-e053-2a91aa0a2a6b
Set id: 321e94ba-4ba9-4392-e054-00144ff88e88
Version: 2
Effective Time: 20181218
 
Phlight Pharma, LLC