Polyethylene Glycol 3350

Manufacturer: Kesin Pharma Corporation
Effective date: 2025-06-12
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 01:02:52

Label at a glance#

ProductPolyethylene Glycol 3350

Active ingredientPOLYETHYLENE GLYCOL 3350

Label structure13 sections

Dosage and administration

do not take more than directed unless advised by your doctor adults and children 17 yearsof age and older: use once a day stir and dissolve one packet of powder (17 g) in any 4 to 8 ounce of beverage (cold, hot or room temperature) then drink do not combine with starch-based thickners used for difficulty swallowing ensure that the powder is fully dissolved before drinking do not drink if there are any clumps do no...

Contacts and useful links#

PhoneLabel contact1-833-537-4679

Label contents#

Full prescribing information#

Polyethylene Glycol 3350 increases frequency of bowel movements and softens stools

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each dose)

OTC - ACTIVE INGREDIENT SECTION

Polyethlene Glycol 3350, 17 g

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:

SPL UNCLASSIFIED SECTION

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 a doctor or pharmacist before use if you are taking

OTC - ASK DOCTOR/PHARMACIST SECTION

a prescription drug

When using this product

OTC - WHEN USING SECTION

you may have 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 need to use a laxative for longer than 1 week
you get diarrhea

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.

OVERDOSAGE 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
adults and children 17 yearsof age and older:
use once a day
stir and dissolve one packet of powder (17 g) in any 4 to 8 ounce of beverage (cold, hot or room temperature) then drink
do not combine with starch-based thickners 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

OTHER SAFETY INFORMATION

store at 20°C to 25°C (68°F to 77°F)
tamper-evident: do not use if printed foil pouch is open or broken
this package is not child-resistant

Inactive ingredients

INACTIVE INGREDIENT SECTION

none

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-833-537-4679

SPL UNCLASSIFIED SECTION

TAMPER-EVIDENT: DO NOT USE IF PRINTED FOIL POUCH IS OPEN OR BROKEN

*This product is not manufactured by Bay HealthCare LLC, owner of the registered trademark MiraLAX ^®

Distributed by:

Kesin Pharma

Oldsmar, FL 34677

Kesin Pharma Logo

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 81033-762-14

Polyethylene Glycol 3350 Powder for Oral Solution

Osmotic Laxative

14 Packets

(14 once-daily-doses)

PEG3350Powder_14count_Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 81033-762-30

Polyethylene Glycol 3350 Powder for Oral Solution

Osmotic Laxative

30 Packets

(30 once-daily doses)

PEG3350Powder_30count_Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 81033-762-01

Polyethylene Glycol 3350 Powder for Oral Solution

Osmotic laxative

100 Packets

(100 once-daily doses)

PEG3350Powder_100count_Carton

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
81033-762-01	Polyethylene Glycol 3350	100 in 1 CARTON	POWDER, FOR SOLUTION	100	2
81033-762-14	Polyethylene Glycol 3350	14 in 1 CARTON	POWDER, FOR SOLUTION	14	2
81033-762-17	Polyethylene Glycol 3350	17 g in 1 PACKET	POWDER, FOR SOLUTION	17	2
81033-762-30	Polyethylene Glycol 3350	30 in 1 CARTON	POWDER, FOR SOLUTION	30	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
81033-762-01	EA - Each	81033-762	71a0d755-2781-4985-b446-2cc15ab39a95	1	2025-12-16
81033-762-14	EA - Each	81033-762	96cdaf44-ed1c-404a-a7d2-1d354a6aec66	1	2025-12-16
81033-762-17	EA - Each	81033-762	f15f6648-d6e0-4858-b729-51d65f37570e	1	2025-12-16
81033-762-30	EA - Each	81033-762	7d10dbdb-1dea-420b-a796-9d352aeb238a	1	2025-12-16

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
81033-762	81033-762-17, 81033-762-14, 81033-762-30, 81033-762-01
59556-762

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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A203928-001	POLYETHYLENE GLYCOL 3350	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL			2016-08-24
A203928-002	POLYETHYLENE GLYCOL 3350	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL			2016-08-24

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 3 · 86 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	A203928-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203928-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2016-08-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203928-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203928-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2016-08-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203928-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203928-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2016-08-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203928-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203928-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2016-08-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203928-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203928-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2016-08-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203928-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203928-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2016-08-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203928-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203928-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2016-08-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203928-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-08-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203928-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2016-08-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203928-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-08-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203928-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2016-08-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203928-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-08-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203928-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2016-08-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203928-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-08-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203928-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2016-08-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203928-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-08-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203928-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2016-08-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203928-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-08-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203928-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2016-08-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203928-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-08-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203928-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2016-08-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203928-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-08-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203928-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2016-08-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203928-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-08-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203928-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2016-08-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203928-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-08-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203928-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2016-08-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203928-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-08-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203928-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2016-08-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203928-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-08-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203928-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2016-08-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203928-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-08-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203928-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2016-08-24	`74a2ff9319b5…`

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
Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	Kesin Pharma Corporation	3729a1d2-4c98-dfdf-e063-6394a90a5a87	2025-06-12	Warnings	Exact identifier ndc (package): 81033-762-30 ndc (package): 81033-762-01 ndc (package): 81033-762-17 ndc (package): 81033-762-14 ndc (product): 81033-762 ndc11 (package): 81033076201 ndc11 (package): 81033076217 ndc11 (package): 81033076230 ndc11 (package): 81033076214 spl id: 3765aba8-f541-9e31-e063-6394a90a80eb spl set id: 3729a1d2-4c98-dfdf-e063-6394a90a5a87

Reported adverse events (FAERS/openFDA)#

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