Polyethylene Glycol 3350, Powder for Solution

Manufacturer: Gericare Pharmaceuticals
Effective date: 2022-10-28
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-05-31 23:51:13

Label at a glance#

ProductPolyethylene Glycol 3350

Active ingredientPOLYETHYLENE GLYCOL 3350

Label structure10 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 (white section in cap) adults and children 17 years of age and older: use once a day fill to top of white 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 temperat...

Contacts and useful links#

PhoneLabel contact1-800-540-3765

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each dose)

OTC - ACTIVE INGREDIENT SECTION

Polyethylene Glycol 3350, 17 grams (cap filled to the indicated 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

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

OTC - ASK DOCTOR/PHARMACIST SECTION

if you are 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

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 childreen

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 (white section in cap)
adults and children 17 years of age and older:
- use once a day
- fill to top of white 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
- do not combine with the 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

OTHER SAFETY 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

INACTIVE INGREDIENT SECTION

none

OTC - QUESTIONS SECTION

Questions or comments?

1-800-540-3765

Manufactured for:

Geri-Care Pharmaceuticals

1295 Townbin Ave. Lakewood, NJ 08701

Product of India

Issued: 07/2022

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Original

Prescription

Strength

Polyethylene Glycol 3350

Powder for Solution

Osmotic Laxative

Relieves Occasional Constipation (Irregularity)
Softens Stool

TAMPER-EVIDENT: DO NOT USE IF PRINTED FOIL SEAL UNDER CAP IS MISSING, OPEN OR BROKEN

Dissolves in any beverage
Sugar Free

NDC 57896-490-01

1 DOSE

NET WT 0.5 OZ (17 g)

NDC 57896-490-03

30 PACKETS

NET WT 0.5 OZ (17 g) Each

NDC 57896-490-07

7 ONCE-DAILY DOSES

NET WT 4.15 OZ (119 g)

NDC 57896-490-14

14 ONCE-DAILY DOSES

NET WT 8.3 OZ (238 g)

NDC 57896-490-30

30 ONCE-DAILY DOSES

NET WT 17.9 OZ (510 g)

NDC 57896-490-45

45 ONCE-DAILY DOSES

NET WT 26.9 OZ (765 g)

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	5
876193	polyethylene glycol 3350 17000 MG Powder for Oral Solution	SCD	5
876193	polyethylene glycol 3350 17 GM Powder for Oral Solution	SY	5

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
57896-490-01	Polyethylene Glycol 3350	17 g in 1 PACKET	POWDER, FOR SOLUTION	17	5
57896-490-03	Polyethylene Glycol 3350	30 in 1 CARTON	POWDER, FOR SOLUTION	30	5
57896-490-07	Polyethylene Glycol 3350	119 g in 1 CAN	POWDER, FOR SOLUTION	119	5
57896-490-14	Polyethylene Glycol 3350	238 g in 1 CAN	POWDER, FOR SOLUTION	238	5
57896-490-30	Polyethylene Glycol 3350	510 g in 1 CAN	POWDER, FOR SOLUTION	510	5
57896-490-45	Polyethylene Glycol 3350	765 g in 1 CAN	POWDER, FOR SOLUTION	765	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57896-490	POLYETHYLENE GLYCOL 3350 POWDER, FOR SOLUTION [GERICARE PHARMACEUTICALS]	5	Current NDC, Legacy NDC, 6 package rows	20221029_5d0d2c14-24e6-45b4-92f6-4eaf5da72cdd.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57896-490-01	EA - Each	57896-490	ede5bbcf-1589-40bf-a1b7-fe5092aaf064	1	2023-06-06
57896-490-03	EA - Each	57896-490	fa65e357-a4c0-4189-8032-3c4329957a53	1	2023-06-06

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
57896-490	57896-490-07, 57896-490-14, 57896-490-30, 57896-490-45, 57896-490-01, 57896-490-03

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 · Source PDF

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	Gericare Pharmaceuticals	5d0d2c14-24e6-45b4-92f6-4eaf5da72cdd	2022-10-28	Warnings	Exact identifier ndc (package): 57896-490-01 ndc (package): 57896-490-45 ndc (package): 57896-490-03 ndc (package): 57896-490-14 ndc (package): 57896-490-30 ndc (package): 57896-490-07 ndc (product): 57896-490 ndc11 (package): 57896049003 ndc11 (package): 57896049014 ndc11 (package): 57896049007 ndc11 (package): 57896049001 ndc11 (package): 57896049030 ndc11 (package): 57896049045 spl id: f0c44850-fe07-4c48-bb9c-ded2c7fb822b spl set id: 5d0d2c14-24e6-45b4-92f6-4eaf5da72cdd

Reported adverse events (FAERS/openFDA)#

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