Prescription Drug Information: Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride – Unflavored (Page 4 of 4)

PRINCIPAL DISPLAY PANEL — UNFLAVORED PACK

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PRINCIPAL DISPLAY PANEL — LEMON FLAVORED PACK

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PRINCIPAL DISPLAY PANEL — ORANGE FLAVORED PACK

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POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE — UNFLAVORED
polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride — unflavored powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64380-768
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 420 g in 4 L
SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE 11.2 g in 4 L
SODIUM BICARBONATE (SODIUM CATION and BICARBONATE ION) SODIUM BICARBONATE 5.72 g in 4 L
POTASSIUM CHLORIDE (POTASSIUM CATION and CHLORIDE ION) POTASSIUM CHLORIDE 1.48 g in 4 L
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64380-768-21 4 L in 1 JUG None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204559 04/14/2015
POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE WITH LEMON FLAVOR
polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride with lemon flavor powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64380-769
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 420 g in 4 L
SODIUM CHLORIDE (CHLORIDE ION and SODIUM CATION) SODIUM CHLORIDE 11.2 g in 4 L
SODIUM BICARBONATE (BICARBONATE ION and SODIUM CATION) SODIUM BICARBONATE 5.72 g in 4 L
POTASSIUM CHLORIDE (CHLORIDE ION and POTASSIUM CATION) POTASSIUM CHLORIDE 1.48 g in 4 L
Inactive Ingredients
Ingredient Name Strength
ACESULFAME POTASSIUM
LEMON
LIME (CITRUS)
Product Characteristics
Color WHITE Score
Shape Size
Flavor LEMON Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64380-769-21 4 L in 1 JUG None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204559 04/14/2015
POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE WITH ORANGE FLAVOR
polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride with orange flavor powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64380-770
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 420 g in 4 L
SODIUM CHLORIDE (CHLORIDE ION and SODIUM CATION) SODIUM CHLORIDE 11.2 g in 4 L
SODIUM BICARBONATE (BICARBONATE ION and SODIUM CATION) SODIUM BICARBONATE 5.72 g in 4 L
POTASSIUM CHLORIDE (CHLORIDE ION and POTASSIUM CATION) POTASSIUM CHLORIDE 1.48 g in 4 L
Inactive Ingredients
Ingredient Name Strength
ACESULFAME POTASSIUM
ORANGE
Product Characteristics
Color WHITE Score
Shape Size
Flavor ORANGE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64380-770-21 4 L in 1 JUG None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204559 04/14/2015
Labeler — Strides Pharma Science Limited (650738743)
Registrant — Strides Pharma Science Limited (650738743)
Establishment
Name Address ID/FEI Operations
Strides Pharma Science Limited 918513263 ANALYSIS (64380-768), ANALYSIS (64380-769), ANALYSIS (64380-770), MANUFACTURE (64380-768), MANUFACTURE (64380-769), MANUFACTURE (64380-770)

Revised: 11/2019 Strides Pharma Science Limited

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