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NDC 69784-0180-14 POLYETHYLENE GLYCOL 3350 NF 17 g/17g Details

POLYETHYLENE GLYCOL 3350 NF 17 g/17g

POLYETHYLENE GLYCOL 3350 NF is a ORAL POWDER, FOR SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Woodward Pharma Services LLC. The primary component is POLYETHYLENE GLYCOL 3350.

MedlinePlus Drug Summary

Polyethylene glycol 3350 is used to treat occasional constipation. Polyethylene glycol 3350 is in a class of medications called osmotic laxatives. It works by causing water to be retained with the stool. This increases the number of bowel movements and softens the stool so it is easier to pass.

Related Packages: 69784-0180-14
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Polyethylene Glycol 3350

Product Information

NDC	69784-0180
Product ID	69784-180_41a32cdc-41d3-4f7c-9cff-d2847dc52b12
Associated GPIs	46600033003020
GCN Sequence Number	034313
GCN Sequence Number Description	polyethylene glycol 3350 POWD PACK 17 G ORAL
HIC3	D6S
HIC3 Description	LAXATIVES AND CATHARTICS
GCN	86211
HICL Sequence Number	022819
HICL Sequence Number Description	POLYETHYLENE GLYCOL 3350
Brand/Generic	Generic
Proprietary Name	POLYETHYLENE GLYCOL 3350 NF
Proprietary Name Suffix	n/a
Non-Proprietary Name	polyethylene glycol 3350
Product Type	HUMAN OTC DRUG
Dosage Form	POWDER, FOR SOLUTION
Route	ORAL
Active Ingredient Strength	17
Active Ingredient Units	g/17g
Substance Name	POLYETHYLENE GLYCOL 3350
Labeler Name	Woodward Pharma Services LLC
Pharmaceutical Class	Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA206105
Listing Certified Through	2024-12-31

Package

Package Images

NDC 69784-0180-14 (69784018014)

Pricing Information
NDC Package Code	69784-180-14
Billing NDC	69784018014
Package	14 POUCH in 1 CARTON (69784-180-14) / 17 g in 1 POUCH (69784-180-01)
Marketing Start Date	2018-06-06
NDC Exclude Flag	N
Price Per Unit	1.13705
Pricing Unit	EA
Effective Date	2024-02-21
NDC Description	POLYETHYLENE GLYCOL 3350 POWD
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 657a51f5-f12f-4b7a-b8fa-2d75d7289f2a Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Polyethylene Glycol 3350, 17 g

Purpose

Osmotic Laxative

Use

relieves occasional constipation (irregularity)
generally produces a bowel movement in 1 to 3 days

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

SPL UNCLASSIFIED SECTION

Ask a doctor before use if you have

nausea, vomiting or abdominal pain
a sudden change in bowel habits that lasts over 2 weeks
irritable bowel syndrome

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

you have rectal bleeding or your nausea, bloating, cramping or abdominal pain gets worse. These may be signs of a serious condition.
you get diarrhea
you need to use a laxative for longer than 1 week

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

do not take more than directed unless advised by your doctor
adults and children 17 years of age and older:
○ stir and dissolve one packet in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink

○ use once a day

○ use no more than 7 days
children 16 years of age or under: ask a doctor

Other information

store at 20° - 25°C (68° - 77°F)
tamper- evident: do not use if printed foil pouch is open or broken

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

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

INGREDIENTS AND APPEARANCE

POLYETHYLENE GLYCOL 3350 NF

polyethylene glycol 3350 powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69784-180(NDC:11534-180)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P)	POLYETHYLENE GLYCOL 3350	17 g in 17 g

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69784-180-14	14 in 1 CARTON	06/06/2018
1	NDC:69784-180-01	17 g in 1 POUCH; Type 0: Not a Combination Product
2	NDC:69784-180-30	30 in 1 CARTON	06/06/2018
2	NDC:69784-180-01	17 g in 1 POUCH; Type 0: Not a Combination Product
3	NDC:69784-180-10	100 in 1 CARTON	06/06/2018
3	NDC:69784-180-01	17 g in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA206105	06/06/2018

Labeler - Woodward Pharma Services LLC (080406260)

Registrant - Woodward Pharma Services LLC (080406260)

Name	Address	ID/FEI	Business Operations
Establishment
Future Pak, Ltd.		087737672	repack(69784-180)

Revised: 7/2022

Document Id: 41a32cdc-41d3-4f7c-9cff-d2847dc52b12

Set id: 657a51f5-f12f-4b7a-b8fa-2d75d7289f2a

Version: 5

Effective Time: 20220729

Search by Drug Name or NDC

NDC 69784-0180-14 POLYETHYLENE GLYCOL 3350 NF 17 g/17g Details

POLYETHYLENE GLYCOL 3350 NF 17 g/17g

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 69784-0180-14 (69784018014)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 657a51f5-f12f-4b7a-b8fa-2d75d7289f2a Details

SPL UNCLASSIFIED SECTION

Active ingredient

Purpose

Use

Warnings

SPL UNCLASSIFIED SECTION

Ask doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Directions

Other information

Inactive ingredient

Questions or comments?

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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