POLYETHYLENE GLYCOL 3350 - polyethylene glycol 3350 powder, for solution 
Aurohealth LLC

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Polyethylene Glycol 3350 Powder for Oral Solution

Drug Facts

Active ingredient (in each dose)

Polyethylene Glycol 3350, USP 17 g (cap filled to line)

Purpose

Osmotic Laxative

Use

Warnings

Allergy alert: Do not use if you are allergic to polyethylene glycol

Do not use if you have kidney disease, except under the advice and supervision of a doctor

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are taking a prescription drug

When using this product you may have loose, watery, more frequent stools

Stop use and ask a doctor if

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Other information

Inactive ingredients

none

Questions or comments?

call 1-855-274-4122

Distributed by:
AUROHEALTH LLC
279 Princeton-Hightstown Road
East Windsor, NJ 08520

Made in India


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 119 g Bottle Label

AUROHEALTH

NDC 58602-805-01

Compare to active ingredient
of MiraLax®*

Polyethylene Glycol 3350
Powder for Oral Solution

Osmotic Laxative

UNFLAVORED POWDER - GRIT FREE

7 ONCE-DAILY DOSES        
NET WT 4.1 OZ (119 g)
 
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 119 g Bottle Label
 

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 17 g Sachet Label

AUROHEALTH

NDC 58602-805-26

Compare to active ingredient
of MiraLax®*

Polyethylene Glycol 3350
Powder for Oral Solution

Osmotic Laxative

UNFLAVORED POWDER - GRIT FREE

1 DOSE

NET WT 0.5 oz (17 g)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 17 g Sachet Carton Label

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 17 g Sachet Carton Label

AUROHEALTH

NDC 58602-805-27

Compare to active ingredient
of MiraLax®*

Polyethylene Glycol 3350
Powder for Oral Solution

Osmotic Laxative

Polyethylene Glycol 3350 powder for
oral solution increases frequency of
bowel movements and softness the stool.

14 ONCE-DAILY DOSES

UNFLAVORED POWDER - GRIT FREE

14 PRE-MEASURED, SINGLE DOSES

14 Packets
NET WT 0.5 oz
(17 g) Each

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 17 g Sachet Label

POLYETHYLENE GLYCOL 3350 
polyethylene glycol 3350 powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-805
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P) POLYETHYLENE GLYCOL 335017 g  in 17 g
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58602-805-01119 g in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package04/09/2018
2NDC:58602-805-02238 g in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package04/09/2018
3NDC:58602-805-03510 g in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package04/09/2018
4NDC:58602-805-04850 g in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package04/09/2018
5NDC:58602-805-25765 g in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package04/23/2024
6NDC:58602-805-2714 in 1 CARTON04/23/2024
617 g in 1 PACKET; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20901704/09/2018
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited918917642ANALYSIS(58602-805) , MANUFACTURE(58602-805)
Establishment
NameAddressID/FEIBusiness Operations
APL HEALTHCARE LIMITED650844777ANALYSIS(58602-805) , MANUFACTURE(58602-805)

Revised: 5/2025
Document Id: 3b9ce08d-1242-4f1e-89a4-65fc2825d365
Set id: d3c77f3f-57aa-4e2d-88aa-731cbb22af70
Version: 7
Effective Time: 20250508
 
Aurohealth LLC