POLYETHYLENE GLYCOL 3350 NF- polyethylene glycol 3350 powder, for solution 
Woodward Pharma Services LLC

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Polyethylene Glycol 3350 powder, for solution

Drug Facts

Active ingredient

Polyethylene Glycol 3350, 17 g

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 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 right away.

Directions

Other information

Inactive ingredient

none

Questions or comments?

1-888-514-4727

PRINCIPAL DISPLAY PANEL

NDC 69784-180-01

Compare to MiraLAX®

Original Prescription Strength

PEG3350

Polyethylene Glycol 3350

Powder for Oral Solution, Osmotic Laxative

Relieves Occasional Constipation (irregularity)

Softens Stool

NET WT 0.5 OZ (17gm)

1 DOSE

2ffddd92-figure-03

PRINCIPAL DISPLAY PANEL

NDC 69784-180-14

Compare to MiraLAX®

Original Prescription Strength

PEG3350

Polyethylene Glycol 3350

Powder for Oral Solution, Osmotic Laxative

Relieves Occasional Constipation (irregularity)

Softens Stool

14 ct Unit-Dose Packets
0.5 OZ (17 gm) each

2ffddd92-figure-03

POLYETHYLENE GLYCOL 3350 NF 
polyethylene glycol 3350 powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69784-180(NDC:11534-180)
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:69784-180-1414 in 1 CARTON06/06/2018
1NDC:69784-180-0117 g in 1 POUCH; Type 0: Not a Combination Product
2NDC:69784-180-3030 in 1 CARTON06/06/2018
2NDC:69784-180-0117 g in 1 POUCH; Type 0: Not a Combination Product
3NDC:69784-180-10100 in 1 CARTON06/06/2018
3NDC:69784-180-0117 g in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20610506/06/2018
Labeler - Woodward Pharma Services LLC (080406260)
Registrant - Woodward Pharma Services LLC (080406260)
Establishment
NameAddressID/FEIBusiness Operations
Future Pak, Ltd.087737672repack(69784-180)

Revised: 7/2022
Document Id: 41a32cdc-41d3-4f7c-9cff-d2847dc52b12
Set id: 657a51f5-f12f-4b7a-b8fa-2d75d7289f2a
Version: 5
Effective Time: 20220729
 
Woodward Pharma Services LLC