GIALAX

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
polyethylene glycol 3350 kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70569-840
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70569-840-01 1 KIT in 1 CARTON None
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POLYETHYLENE GLYCOL 3350 (POLYETHYLENE GLYCOL 3350) 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 Multilevel Packaging
1 527 g in 1 BOTTLE None
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 DEA Schedule
Inactive Ingredients
Ingredient Name Strength
ASCORBIC ACID
XANTHAN GUM
PIGMENT BLUE 1
ASPARTAME
SODIUM CHLORIDE
POTASSIUM CITRATE
MALTODEXTRIN
ACESULFAME POTASSIUM
CALCIUM SILICATE
ANHYDROUS CITRIC ACID
MONOPOTASSIUM PHOSPHITE
FD&C YELLOW NO. 5
Product Characteristics
Color Score
Shape Size
Flavor BLUEBERRY (“Blue Raz”) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 3 g in 1 PACKET None
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 Operations
Phlight Pharma, LLC 080168751 label (70569-840)

Revised: 12/2018 Phlight Pharma, LLC

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