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

PRINCIPAL DISPLAY PANEL — UNFLAVORED PACK

unflavored.jpg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — LEMON FLAVORED PACK

lemon.jpg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — ORANGE FLAVORED PACK

orange.jpg
(click image for full-size original)
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: 11/2022 Strides Pharma Science Limited

Page 4 of 4 1 2 3 4

RxDrugLabels.com provides trustworthy package insert and label information about marketed prescription drugs as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by RxDrugLabels.com. Every individual prescription drug label and package insert entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

As a leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. RxDrugLabels.com provides the full prescription-only subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2024. All Rights Reserved.