Polyethylene Glycol 3350

Manufacturer: Marlex Pharmaceuticals Inc
Effective date: 2019-05-21
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:59:29

Label at a glance#

ProductPolyethylene Glycol 3350

Active ingredientPOLYETHYLENE GLYCOL 3350

Label structure12 sections

Dosage and administration

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 d...

Contacts and useful links#

PhoneFDA MedWatch1-800-FDA-1088

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

MARLEX PHARMACEUTICALS, INC

----------

Polyethylene Glycol 3350 powder, for solution

Drug Facts

Active ingredient (in each dose)

OTC - ACTIVE INGREDIENT SECTION

Polyethylene Glycol 3350, 17 g (cap filled to line)

Purpose

OTC - PURPOSE SECTION

Osmotic Laxative

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Allergy alert:

Do not use if you are allergic to polyethylene glycol

Do not use

OTC - DO NOT USE SECTION

if you have kidney disease, except under the advice and supervision of a doctor

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

taking a prescription drug

When using this product

OTC - WHEN USING SECTION

you may loose, watery, more frequent stools

Stop use and ask a doctor if

OTC - STOP USE SECTION

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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

SAFE HANDLING WARNING SECTION

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

INACTIVE INGREDIENT SECTION

none

Questions or comments?

OTC - QUESTIONS SECTION

1-800-FDA-1088

Manufactured for & Distributed by:

Marlex Pharmaceuticals, Inc.

New Castle, DE 19720

Rev. 04/19IT

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 10135-0683-04
Polyethylene Glycol
3350
Powder for Solution, Osmotic Laxative
Net Wt 4.1 oz (119 g)
7 Once-Daily Doses

PRINCIPAL DISPLAY PANEL NDC 10135-0683-04 Polyethylene Glycol 3350 Powder for Solution, Osmotic Laxative Net Wt 4.1 oz (119 g) 7 Once-Daily Doses

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 10135-0683-08
Polyethylene Glycol
3350
Powder for Solution, Osmotic Laxative
Net Wt 8.3 oz (238 g)
14 Once-Daily Doses

PRINCIPAL DISPLAY PANEL NDC 10135-0683-08 Polyethylene Glycol 3350 Powder for Solution, Osmotic Laxative Net Wt 8.3 oz (238 g) 14 Once-Daily Doses

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 10135-0683-12
Polyethylene Glycol
3350
Powder for Solution, Osmotic Laxative
Net Wt 17.9 oz (510 g)
30 Once-Daily Doses

PRINCIPAL DISPLAY PANEL NDC 10135-0683-12 Polyethylene Glycol 3350 Powder for Solution, Osmotic Laxative Net Wt 17.9 oz (510 g) 30 Once-Daily Doses

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
876193	polyethylene glycol 3350 17 GM Powder for Oral Solution	PSN	2
876193	polyethylene glycol 3350 17000 MG Powder for Oral Solution	SCD	2
876193	polyethylene glycol 3350 17 GM Powder for Oral Solution	SY	2

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
POLYETHYLENE GLYCOL 3350 Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
10135-683-04	2021-01-29	C162847	48780-1	ba0f9c33-1230-a910-e053-dadaa90a0b85	Polyethylene Glycol 3350
10135-683-08	2021-01-29	C162847	48780-1	ba0f9c33-1230-a910-e053-dadaa90a0b85	Polyethylene Glycol 3350
10135-683-12	2021-01-29	C162847	48780-1	ba0f9c33-1230-a910-e053-dadaa90a0b85	Polyethylene Glycol 3350

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
10135-683-04	Polyethylene Glycol 3350	119 g in 1 BOTTLE	POWDER, FOR SOLUTION	119	2
10135-683-08	Polyethylene Glycol 3350	238 g in 1 BOTTLE	POWDER, FOR SOLUTION	238	2
10135-683-12	Polyethylene Glycol 3350	510 g in 1 BOTTLE	POWDER, FOR SOLUTION	510	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10135-683	POLYETHYLENE GLYCOL 3350 POWDER, FOR SOLUTION [MARLEX PHARMACEUTICALS INC]	2	Legacy NDC, 3 package rows	20190518_5d2b2570-444b-4263-b339-bd81171979d6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10135-683-04	GM - Gram	10135-683	b525cf0c-7183-4e9c-9e52-a662880619d9	1	2019-06-19
10135-683-08	GM - Gram	10135-683	fa58e979-8efc-4b73-ac89-9e6294571618	1	2019-06-19
10135-683-12	GM - Gram	10135-683	c61bfa76-3956-44d9-83df-158d29a42dc1	1	2019-06-19

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 1 matching rows.

Polyethylene Glycol 3350

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
10135-683	10135-683-04, 10135-683-08, 10135-683-12

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
POLYETHYLENE GLYCOL 3350	G2M7P15E5P	ACTIB

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A202071-001	POLYETHYLENE GLYCOL 3350	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL			2012-12-28

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A202071-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2012-12-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202071-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2012-12-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202071-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2012-12-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202071-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2012-12-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202071-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2012-12-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202071-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2012-12-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202071-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2012-12-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202071-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2012-12-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202071-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2012-12-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202071-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2012-12-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202071-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2012-12-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202071-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2012-12-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202071-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2012-12-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202071-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2012-12-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202071-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2012-12-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202071-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2012-12-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202071-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2012-12-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202071-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2012-12-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202071-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2012-12-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202071-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2012-12-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202071-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2012-12-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202071-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2012-12-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202071-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2012-12-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202071-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2012-12-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202071-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2012-12-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202071-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2012-12-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202071-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2012-12-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202071-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2012-12-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202071-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2012-12-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202071-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2012-12-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202071-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2012-12-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202071-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2012-12-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202071-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2012-12-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202071-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2012-12-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202071-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2012-12-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202071-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2012-12-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202071-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2012-12-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202071-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2012-12-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202071-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2012-12-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202071-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2012-12-28	`f41ea6bd6efb…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
d29eb471-03ff-4fee-b97e-ea68cbbe5aab			5d2b2570-444b-4263-b339-bd81171979d6	2019-05-21	Warnings	Exact identifier spl id: d29eb471-03ff-4fee-b97e-ea68cbbe5aab spl set id: 5d2b2570-444b-4263-b339-bd81171979d6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.