Drug Facts Polyethylene Glycol 3350, Powder for Oral Solution

Manufacturer: American Health Packaging
Effective date: 2026-02-18
Label type: HUMAN OTC DRUG LABEL
Version: 6
Source: full-release
Hydrated at: 2026-06-01 01:46:24

Label at a glance#

ProductPolyethylene Glycol 3350

Active ingredientPOLYETHYLENE GLYCOL 3350

Label structure11 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 adults and children 17 years of age and older: use once a day stir and dissolve one sachet of powder (17 g) in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink do not combine with starch-based thickeners used for difficulty swallowing. ensure that the powder is fully dissolved before drinking do not drink if there are any clumps d...

Contacts and useful links#

PhoneLabel contact1-800-707-4621

Websitewww.americanhealthpackaging.com

www.americanhealthpackaging.com

Label contents#

Full prescribing information#

Active Ingredient (in each sachet)

OTC - ACTIVE INGREDIENT SECTION

Polyethylene Glycol 3350, NF 17g

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 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 of pharmacist

OTC - ASK DOCTOR/PHARMACIST SECTION

before use 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

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 the 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
adults and children 17 years of age and older:
use once a day
stir and dissolve one sachet of powder (17 g) in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
do not combine with 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

SPL UNCLASSIFIED SECTION

store at 20° - 25°C (68° - 77°F)
do not use if foil is open or broken.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

none

Questions or comments?

OTC - QUESTIONS SECTION

1-800-707-4621 or www.americanhealthpackaging.com

1047662/1047664/1049041/1046550

Package/Label Display Panel - Carton - 17 g - 14UD

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

17 g Healthylax Carton (14 Sachet)

NDC 60687- 431-98

healthylax ^®
POLYETHYLENE GLYCOL 3350 NF
Powder for Oral Laxative Solution

14 SACHETS
Net Wt. 0.6 OZ (17g) EACH

Distributed by American Health Packaging, Columbus, Ohio 43217

PACKAGE/LABEL DISPLAY PANEL - CARTON - 17 G - 30UD

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

17 g healthylax Carton - 30UD

NDC 60687- 431-27

healthylax ^®
POLYETHYLENE GLYCOL 3350 NF
Powder for Oral Laxative Solution

30 SACHETS
Net Wt. 18 OZ (510g)

Distributed by American Health Packaging, Columbus, Ohio 43217

Package/Label Display Panel - Carton - 17 g - 100UD

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

100 Ct Healthylax Carton

NDC 60687- 431-92

healthylax ^®
P OLYETHYLENE GLYCOL 3350 NF
Powder for Oral Laxative Solution

100 - 17 g SACHETS
Net Wt. 0.6 OZ (1700g)

Distributed by American Health Packaging, Columbus, Ohio 43217

Package/Label Display Panel – Sachet – 17 g

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

17 g HealthyLax Sachet

NDC 60687- 431-99

healthylax ^®
POLYETHYLENE GLYCOL 3350 NF
Powder for Oral Laxative Solution

Net Wt. 0.6 OZ (17g)

Distributed by American Health Packaging, Columbus, Ohio 43217

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	6
876193	polyethylene glycol 3350 17000 MG Powder for Oral Solution	SCD	6
876193	polyethylene glycol 3350 17 GM Powder for Oral Solution	SY	6

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	DataBar Limited	(01)00360687431994	GTIN-14: 00360687431994 GTIN-12: 360687431994 UPC-A: 360687431994 EAN-13: 0360687431994 GTIN storage (14 digits): 00360687431994	Sachet_HealthyLax_0219.jpg

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
60687-431-27	Polyethylene Glycol 3350	30 in 1 CARTON	POWDER, FOR SOLUTION	30	6
60687-431-92	Polyethylene Glycol 3350	100 in 1 CARTON	POWDER, FOR SOLUTION	100	6
60687-431-98	Polyethylene Glycol 3350	14 in 1 CARTON	POWDER, FOR SOLUTION	14	6
60687-431-99	Polyethylene Glycol 3350	17 g in 1 POUCH	POWDER, FOR SOLUTION	17	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60687-431-27	EA - Each	60687-431	a45e2a1e-1e0f-48ae-9277-9787532f64e8	1	2023-10-16
60687-431-92	EA - Each	60687-431	039fb68e-505e-4c6a-a901-cff7d9792e80	1	2020-03-10
60687-431-98	EA - Each	60687-431	a62b1823-5483-454d-8430-eedb0677b7e3	1	2019-05-02
60687-431-99	EA - Each	60687-431	6c1de407-c6a8-4ca1-9aca-c2c9b74340bf	1	2019-05-02

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
60687-431	60687-431-99, 60687-431-98, 60687-431-92, 60687-431-27

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	American Health Packaging	81374641-e54c-4b41-a3ad-49b19a097666	2026-02-18	Warnings	Exact identifier ndc (package): 60687-431-27 ndc (package): 60687-431-99 ndc (package): 60687-431-98 ndc (package): 60687-431-92 ndc (product): 60687-431 ndc11 (package): 60687043192 ndc11 (package): 60687043199 ndc11 (package): 60687043198 ndc11 (package): 60687043127 spl id: 4b1bc1a8-dcf3-f253-e063-6394a90a2bb1 spl set id: 81374641-e54c-4b41-a3ad-49b19a097666

Reported adverse events (FAERS/openFDA)#

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