Polyethylene Glycol 3350

Manufacturer: Lannett Company, Inc.
Effective date: 2010-03-05
Label type: HUMAN OTC DRUG LABEL
Version: 6
Source: legacy-cache
Hydrated at: 2026-08-01 23:43:17

Label at a glance#

ProductPolyethylene Glycol 3350

Active ingredientPOLYETHYLENE GLYCOL 3350

Label structure9 sections

Indications and uses

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

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 adults and children 17 years of age and older: fill to 17 grams line in cap for the correct dose stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink use once daily use no more than 7 days children 16 years of ...

Contacts and useful links#

PhoneLabel contact1-800-477-7877

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Laxative

Uses

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/PHARMACIST 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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

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
adults and children 17 years of age and older:
- fill to 17 grams line in cap for the correct dose
- stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
- use once daily
- use no more than 7 days
children 16 years of age or under: ask a doctor

Other information

SPL UNCLASSIFIED SECTION

store at 20° - 25°C (68° - 77°F)
tamper-evident: do not use if printed foil seal under cap is missing, open or broken

Inactive ingredients

INACTIVE INGREDIENT SECTION

none

Questions or comments?

OTC - QUESTIONS SECTION

1-800-477-7877

Distributed by

Kremers Urban, LLC

Princeton, NJ 08540 USA

Rev. 1E

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Original Prescription Strength

Relieves Occasional Constipation
Softens Stool
4.1 oz Label. Drug Facts on ECL.
8.9 oz Label. Drug Facts on ECL.
18.5 oz Label. Drug Facts on ECL.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62175-195-07	GM - Gram	62175-195	0ac52f97-b16b-40d6-a7ee-78346bf7b6b9	1	2012-07-24
62175-195-15	GM - Gram	62175-195	430c52a4-016e-40b8-8ac1-aaec81f1c2be	1	2012-07-24
62175-195-31	GM - Gram	62175-195	b19de735-957b-4f2e-b222-53190685be4d	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version	Uploaded
POLYETHYLENE GLYCOL 3350	ACTIVE INGREDIENT	G2M7P15E5P	4
POLYETHYLENE GLYCOL 3350	ACTIVE MOIETY	G2M7P15E5P	4

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
62175-195	62175-195-07, 62175-195-15, 62175-195-31

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
A090600-001	GLYCOLAX	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL			2009-10-06
A090600-002	GLYCOLAX	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL			2009-10-06

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	A090600-001	GLYCOLAX	17GM/PACKET	FOR SOLUTION / ORAL	2009-10-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090600-002	GLYCOLAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090600-001	GLYCOLAX	17GM/PACKET	FOR SOLUTION / ORAL	2009-10-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090600-002	GLYCOLAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090600-001	GLYCOLAX	17GM/PACKET	FOR SOLUTION / ORAL	2009-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090600-002	GLYCOLAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090600-001	GLYCOLAX	17GM/PACKET	FOR SOLUTION / ORAL	2009-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090600-002	GLYCOLAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090600-001	GLYCOLAX	17GM/PACKET	FOR SOLUTION / ORAL	2009-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090600-002	GLYCOLAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090600-001	GLYCOLAX	17GM/PACKET	FOR SOLUTION / ORAL	2009-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090600-002	GLYCOLAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090600-001	GLYCOLAX	17GM/PACKET	FOR SOLUTION / ORAL	2009-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090600-002	GLYCOLAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090600-001	GLYCOLAX	17GM/PACKET	FOR SOLUTION / ORAL	2009-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090600-002	GLYCOLAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090600-001	GLYCOLAX	17GM/PACKET	FOR SOLUTION / ORAL	2009-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090600-002	GLYCOLAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090600-001	GLYCOLAX	17GM/PACKET	FOR SOLUTION / ORAL	2009-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090600-002	GLYCOLAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090600-001	GLYCOLAX	17GM/PACKET	FOR SOLUTION / ORAL	2009-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090600-002	GLYCOLAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090600-001	GLYCOLAX	17GM/PACKET	FOR SOLUTION / ORAL	2009-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090600-002	GLYCOLAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090600-001	GLYCOLAX	17GM/PACKET	FOR SOLUTION / ORAL	2009-10-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090600-002	GLYCOLAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090600-001	GLYCOLAX	17GM/PACKET	FOR SOLUTION / ORAL	2009-10-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090600-002	GLYCOLAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090600-001	GLYCOLAX	17GM/PACKET	FOR SOLUTION / ORAL	2009-10-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090600-002	GLYCOLAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090600-001	GLYCOLAX	17GM/PACKET	FOR SOLUTION / ORAL	2009-10-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090600-002	GLYCOLAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090600-001	GLYCOLAX	17GM/PACKET	FOR SOLUTION / ORAL	2009-10-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090600-002	GLYCOLAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090600-001	GLYCOLAX	17GM/PACKET	FOR SOLUTION / ORAL	2009-10-06	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090600-002	GLYCOLAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090600-001	GLYCOLAX	17GM/PACKET	FOR SOLUTION / ORAL	2009-10-06	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090600-002	GLYCOLAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090600-001	GLYCOLAX	17GM/PACKET	FOR SOLUTION / ORAL	2009-10-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090600-002	GLYCOLAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`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
65489485-97fb-43e4-b582-6d9feeba2e0a			17d62f30-c6c6-49fe-bbf6-fed0f36e2b16	2010-03-05	Warnings	Exact identifier spl set id: 17d62f30-c6c6-49fe-bbf6-fed0f36e2b16

Reported adverse events (FAERS/openFDA)#

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