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NDC 11534-0180-19 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 SUNRISE 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: 11534-0180-19
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Polyethylene Glycol 3350

Product Information

NDC	11534-0180
Product ID	11534-180_020b7f87-0f3a-4223-a402-dea12a6c53d2
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 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	SUNRISE 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	ANDA206105
Listing Certified Through	2024-12-31

Package

Package Images

NDC 11534-0180-19 (11534018019)

Pricing Information	N/A
NDC Package Code	11534-180-19
Billing NDC	11534018019
Package	119 g in 1 BOTTLE (11534-180-19)
Marketing Start Date	2017-06-13
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ce5197a1-2677-4ffb-aef2-9221b28ebd23 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each dose)

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

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 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
the bottle top is a measuring cap marked to contain 17 grams of powder when filled to the indicated line (clear section in cap)
adults and children 17 years of age and older:
○ fill to top of clear section 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

○ 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 foil seal under cap, printed with “SEALED for YOUR PROTECTION” is missing, open or broken

Inactive ingredient

none

Questions or comments?

1-800-FDA-1088

Manufactured & Distributed by:

Sunrise Pharmaceutical, Inc.

Rahway, NJ 07065

PRINCIPAL DISPLAY PANEL

NDC 11534-180-19

Polyethylene Glycol

3350

Powder for Solution, Osmotic Laxative

Relieves Occasional
Constipation/Irregularity
Softens Stool
Dissolves in Any Beverage
Unflavored Powder Grit Free

Polyethylene Glycol 3350 increases frequency of bowel movements and softens the stool.

NDC 11534-180-28

Polyethylene Glycol

3350

Powder for Solution, Osmotic Laxative
Relieves Occasional
Constipation/Irregularity
Softens Stool
Dissolves in Any Beverage
Unflavored Powder Grit Free

Polyethylene Glycol 3350 increases frequency of bowel movements and softens the stool.

NDC 11534-180-50

Polyethylene Glycol

3350

Powder for Solution, Osmotic Laxative
Relieves Occasional
Constipation/Irregularity
Softens Stool
Dissolves in Any Beverage

: Unflavored Powder Grit Free

Polyethylene Glycol 3350 increases frequency of bowel movements and softens the stool.

INGREDIENTS AND APPEARANCE

POLYETHYLENE GLYCOL 3350 NF

polyethylene glycol 3350 powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	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:11534-180-19	119 g in 1 BOTTLE; Type 0: Not a Combination Product	06/13/2017
2	NDC:11534-180-28	238 g in 1 BOTTLE; Type 0: Not a Combination Product	06/13/2017
3	NDC:11534-180-50	510 g in 1 BOTTLE; Type 0: Not a Combination Product	06/13/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA206105	06/13/2017

Labeler - SUNRISE PHARMACEUTICAL, INC (168522378)

Registrant - SUNRISE PHARMACEUTICAL, INC (168522378)

Name	Address	ID/FEI	Business Operations
Establishment
SUNRISE PHARMACEUTICAL INC.		168522378	MANUFACTURE(11534-180) , ANALYSIS(11534-180) , PACK(11534-180)

Revised: 1/2020

Document Id: 020b7f87-0f3a-4223-a402-dea12a6c53d2

Set id: ce5197a1-2677-4ffb-aef2-9221b28ebd23

Version: 2

Effective Time: 20200122

Search by Drug Name or NDC

NDC 11534-0180-19 POLYETHYLENE GLYCOL 3350 NF 17 g/17g Details

POLYETHYLENE GLYCOL 3350 NF 17 g/17g

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 11534-0180-19 (11534018019)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL ce5197a1-2677-4ffb-aef2-9221b28ebd23 Details

SPL UNCLASSIFIED SECTION

Active ingredient (in each dose)

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

INGREDIENTS AND APPEARANCE

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