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 grams (cup filled to the indicated 17 grams 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

Code: TS/DRUGS/19/1993

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
 

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
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)

Revised: 6/2021
Document Id: 3e8f5acd-e6b3-405d-afb3-b94691c522fe
Set id: d3c77f3f-57aa-4e2d-88aa-731cbb22af70
Version: 4
Effective Time: 20210608
 
Aurohealth LLC