Search by Drug Name or NDC

NDC 63739-0198-61 SKY PEG3350 17 g/17g Details

SKY PEG3350 17 g/17g

SKY PEG3350 is a ORAL POWDER, FOR SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by McKesson Corporation dba SKY Packaging. 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: 63739-0198-61
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Polyethylene Glycol 3350

Product Information

NDC	63739-0198
Product ID	63739-198_79c20e03-f175-4502-81b1-58d833ca4ec9
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	SKY PEG3350
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	McKesson Corporation dba SKY Packaging
Pharmaceutical Class	Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA090685
Listing Certified Through	2024-12-31

Package

Package Images

NDC 63739-0198-61 (63739019861)

Pricing Information
NDC Package Code	63739-198-61
Billing NDC	63739019861
Package	30 POUCH in 1 CARTON (63739-198-61) / 17 g in 1 POUCH (63739-198-62)
Marketing Start Date	2020-06-08
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 9f80bf15-af0b-4a6d-84cd-f5fc317e3318 Details

Active ingredient (in each dose)

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

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 (1-800-222-1222).

Directions

•: do not take more than directed unless advised by your doctor
•: adults and children 17 years of age and older:
•: use once a day
•: stir and dissolve one packet of powder (17 g) 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
•: 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 ingredients

none

Questions or comments?

1-800-719-9260

Principal Display Panel

SKY

Compare to MiraLAX® active ingredient

PEG3350

Polyethylene Glycol 3350 Powder for Solution, Osmotic Laxative

- Relieves Occasional Constipation (Irregularity) –

- Softens Stool -

Unflavored Powder ● Grit Free

Unflavored Powder Dissolves In Any Beverage!

30 Once-Daily Doses

30 Packets – NET WT 0.5 OZ (17g) Each

INGREDIENTS AND APPEARANCE

SKY PEG3350

polyethylene glycol 3350 powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63739-198
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:63739-198-61	30 in 1 CARTON	06/08/2020
1	NDC:63739-198-62	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	ANDA090685	06/08/2020

Labeler - McKesson Corporation dba SKY Packaging (140529962)

Revised: 4/2022

Document Id: 79c20e03-f175-4502-81b1-58d833ca4ec9

Set id: 9f80bf15-af0b-4a6d-84cd-f5fc317e3318

Version: 3

Effective Time: 20220414