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NDC 51991-0961-58 Polyethylene Glycol 3350 17 g/17g Details

Polyethylene Glycol 3350 17 g/17g

Polyethylene Glycol 3350 is a ORAL POWDER, FOR SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Breeckenridge Pharmaceutical, Inc.. 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: 51991-0961-58
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Polyethylene Glycol 3350

Product Information

NDC	51991-0961
Product ID	51991-961_5f8f9f53-2c72-4a5c-9e50-894154140bcc
Associated GPIs	46600033002910
GCN Sequence Number	041843
GCN Sequence Number Description	polyethylene glycol 3350 POWDER 17 G/DOSE ORAL
HIC3	D6S
HIC3 Description	LAXATIVES AND CATHARTICS
GCN	86212
HICL Sequence Number	022819
HICL Sequence Number Description	POLYETHYLENE GLYCOL 3350
Brand/Generic	Generic
Proprietary Name	Polyethylene Glycol 3350
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	Breeckenridge Pharmaceutical, Inc.
Pharmaceutical Class	Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA090812
Listing Certified Through	n/a

Package

Package Images

NDC 51991-0961-58 (51991096158)

Pricing Information
NDC Package Code	51991-961-58
Billing NDC	51991096158
Package	238 g in 1 BOTTLE (51991-961-58)
Marketing Start Date	2019-03-27
NDC Exclude Flag	N
Price Per Unit	0.02425
Pricing Unit	GM
Effective Date	2024-02-21
NDC Description	POLYETHYLENE GLYCOL 3350 POWD
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1, 5
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 2b97ad05-989e-47b4-bb9a-60139c13d33b Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each dose)

Polyethylene Glycol 3350, 17 g (cup filled to the indicated "17 GRAMS" line)

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

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 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

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
this product is supplied with a dosing cup marked to contain 17 grams of powder when filled to the indicated line
adults and children 17 years of age and older:
- use once a day
- fill to the indicated "17 GRAMS" line on cup which is marked to indicate the correct dose 17 g
- stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
- do not combine with starch-based thickeners used for difficulty swallowing
- ensure that the powder is fully dissolved before drinking
- do not drink if there are any clumps
- do not use 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 foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken

Inactive ingredients

none

Questions or Comments?

call: 1-800-367-3395

SPL UNCLASSIFIED SECTION

Manufactured by:

LGM Pharma Solutions, LLC

Irvine, CA 92614

Distributed by:

Breckenridge Pharmaceutical, Inc.

Berlin, CT 06037

PRINCIPAL DISPLAY PANEL - 238 g Bottle Label

NDC 51991-961-58

Polyethylene Glycol

3350, NF

Powder for Solution,

Osmotic Laxative

Relieves Occasional

Constipation / Irregularity
Softens Stool
Unflavored Powder
Sugar Free

NET WT. 8.3 OZ (238 g)

14 ONCE - DAILY DOSES

breckenridge

A Towa

Company

Principal Display Panel - 238 g Bottle Label

PRINCIPAL DISPLAY PANEL - 510 g Bottle Label

NDC 51991-962-57

Polyethylene Glycol

3350, NF

Powder for Solution,

Osmotic Laxative

Relieves Occasional

Constipation/ Irregularity
Softens Stool
Unflavored Powder
Sugar Free

NET WT 17.9 OZ (510 g)

30 ONCE - DAILY DOSES

breckenridge

A Towa

Company

Principal Display Panel - 510 g Bottle Label

INGREDIENTS AND APPEARANCE

POLYETHYLENE GLYCOL 3350

polyethylene glycol 3350 powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51991-961
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	Marketing End Date
Packaging
1	NDC:51991-961-58	238 g in 1 BOTTLE; Type 0: Not a Combination Product	03/27/2019	09/30/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA090812	03/27/2019	09/30/2024

POLYETHYLENE GLYCOL 3350

polyethylene glycol 3350 powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51991-962
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	Marketing End Date
Packaging
1	NDC:51991-962-57	510 g in 1 BOTTLE; Type 0: Not a Combination Product	03/27/2019	07/31/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA090812	03/27/2019	09/30/2024

Labeler - Breeckenridge Pharmaceutical, Inc. (150554335)

Name	Address	ID/FEI	Business Operations
Establishment
LGM Pharma Solutions, LLC		117549200	MANUFACTURE(51991-961, 51991-962)

Revised: 10/2022

Document Id: 5f8f9f53-2c72-4a5c-9e50-894154140bcc

Set id: 2b97ad05-989e-47b4-bb9a-60139c13d33b

Version: 7

Effective Time: 20221004

Search by Drug Name or NDC

NDC 51991-0961-58 Polyethylene Glycol 3350 17 g/17g Details

Polyethylene Glycol 3350 17 g/17g

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 51991-0961-58 (51991096158)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 2b97ad05-989e-47b4-bb9a-60139c13d33b Details

SPL UNCLASSIFIED SECTION

Active ingredient (in each dose)

Purpose

Use

Warnings

Allergy alert

Ask a doctor before use if you have

Stop use and ask a doctor if

Directions

Other information

Inactive ingredients

Questions or Comments?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 238 g Bottle Label

PRINCIPAL DISPLAY PANEL - 510 g Bottle Label

INGREDIENTS AND APPEARANCE

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