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NDC 68001-0505-55 Polyethylene Glycol 17 g/17g Details

Polyethylene Glycol 17 g/17g

Polyethylene Glycol is a ORAL POWDER, FOR SUSPENSION in the HUMAN OTC DRUG category. It is labeled and distributed by BluePoint Laboratories. 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: 68001-0505-55
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Polyethylene Glycol 3350

Product Information

NDC	68001-0505
Product ID	68001-505_cc6e2865-14e2-1ac7-e053-2a95a90acbc0
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
Proprietary Name Suffix	n/a
Non-Proprietary Name	Polyethylene Glycol
Product Type	HUMAN OTC DRUG
Dosage Form	POWDER, FOR SUSPENSION
Route	ORAL
Active Ingredient Strength	17
Active Ingredient Units	g/17g
Substance Name	POLYETHYLENE GLYCOL 3350
Labeler Name	BluePoint Laboratories
Pharmaceutical Class	Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA091077
Listing Certified Through	2024-12-31

Package

Package Images

NDC 68001-0505-55 (68001050555)

Pricing Information
NDC Package Code	68001-505-55
Billing NDC	68001050555
Package	238 g in 1 BOTTLE (68001-505-55)
Marketing Start Date	2021-06-18
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 c4cae70c-68da-0bbc-e053-2a95a90a395a Details

ACTIVE INGREDIENT

Polyethylene Glycol 3350, 17 g (cap filled to 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 THE 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
the bottle top is a measuring cap 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 top of line in cap 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?

1-866-403-7592

Package Label - Principal Display Panel

NDC: 68001-505-55

Original Prescription Strength

Polyethylene Glycol 3350

Powder for Solution, 17g/dose

Osmotic Laxative

14 ONCE-DAILY DOSES

NET WT 8.3 OZ (238 g)

INGREDIENTS AND APPEARANCE

POLYETHYLENE GLYCOL

polyethylene glycol powder, for suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68001-505
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

Ingredient Name	Strength
Inactive Ingredients
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:68001-505-55	238 g in 1 BOTTLE; Type 0: Not a Combination Product	06/18/2021
2	NDC:68001-505-69	510 g in 1 BOTTLE; Type 0: Not a Combination Product	06/18/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA091077	06/18/2021

Labeler - BluePoint Laboratories (985523874)

Name	Address	ID/FEI	Business Operations
Establishment
Novel Laboratories Inc.		793518643	analysis(68001-505) , manufacture(68001-505) , pack(68001-505)

Revised: 9/2021

Document Id: cc6e2865-14e2-1ac7-e053-2a95a90acbc0

Set id: c4cae70c-68da-0bbc-e053-2a95a90a395a

Version: 3

Effective Time: 20210920