Polyethylene Glycol 3350, NF Powder for Oral Solution

Manufacturer: ATLANTIC BIOLOGICALS CORP.
Effective date: 2024-06-04
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: legacy-cache
Hydrated at: 2026-08-01 21:01:12

Label at a glance#

ProductPolyethylene Glycol 3350

Active ingredientPOLYETHYLENE GLYCOL 3350

Label structure11 sections

Dosage and administration

do not take more than directed unless advised by your doctor this product is supplied with a dosing cup marked to contain 17 grams of powder when filled to the indicated line. adults and children 17 years of age and older: fill to the indicated "17 GRAMS" line on cup which is marked to indicate the correct dose 17 grams stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink E...

Storage and handling

store at 20° - 25°C (68° - 77°F) tamper-evident: do not use if seal under cap printed with "SEALED for YOUR PROTECTION" is missing, open or broken.

Contacts and useful links#

PhoneLabel contact1-800-367-3395

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each dose)

OTC - ACTIVE INGREDIENT SECTION

Polyethylene Glycol 3350, 17 grams (cup filled to the indicated "17 GRAMS" 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

SPL UNCLASSIFIED SECTION

Do not use if you are allergic to polyethylene glycol

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking a prescription drug.

OTC - WHEN USING SECTION

When using this product 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 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
this product is supplied with a dosing cup marked to contain 17 grams of powder when filled to the indicated line.
adults and children 17 years of age and older:
- fill to the indicated "17 GRAMS" line on cup which is marked to indicate the correct dose 17 grams
- stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
- Ensure that the powder is fully dissolved before drinking.
- Do not drink if there are any clumps.
- use once a day
- use no more than 7 days
children 16 years of age or younger: ask a doctor

Other information

STORAGE AND HANDLING SECTION

store at 20° - 25°C (68° - 77°F)
tamper-evident: do not use if seal under cap printed with "SEALED for YOUR PROTECTION" is missing, open or broken.

Inactive ingredients

INACTIVE INGREDIENT SECTION

none

Questions or Comments?

OTC - QUESTIONS SECTION

call: 1-800-367-3395

SPL UNCLASSIFIED SECTION

Manufactured by:
LGM Pharma Solutions, LLC
Irvine, CA 92614

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

PRINCIPAL DISPLAY PANEL - 510 g Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Polyethylene Glycol

3350 NF

Powder For Solution,
Osmotic Laxative

Relieves Occasional
Constipation/ Irregularity
Softens stool

image 1

image 2

image 3

image 4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
17856-0962-1	2024-06-04	C162847	48780-1	f386c649-bd27-0266-e053-dadaa90a7c1a	Polyethylene Glycol 3350, NF Powder for Oral Solution
17856-0962-2	2024-06-04	C162847	48780-1	f386c649-bd27-0266-e053-dadaa90a7c1a	Polyethylene Glycol 3350, NF Powder for Oral Solution
17856-0962-3	2024-06-04	C162847	48780-1	f386c649-bd27-0266-e053-dadaa90a7c1a	Polyethylene Glycol 3350, NF Powder for Oral Solution
17856-0962-4	2024-06-04	C162847	48780-1	f386c649-bd27-0266-e053-dadaa90a7c1a	Polyethylene Glycol 3350, NF Powder for Oral Solution
17856-0962-5	2024-06-04	C162847	48780-1	f386c649-bd27-0266-e053-dadaa90a7c1a	Polyethylene Glycol 3350, NF Powder for Oral Solution
17856-0962-1	2023-01-30	C162847	48780-1	f386c649-bd27-0266-e053-dadaa90a7c1a	Polyethylene Glycol 3350, NF Powder for Oral Solution
17856-0962-2	2023-01-30	C162847	48780-1	f386c649-bd27-0266-e053-dadaa90a7c1a	Polyethylene Glycol 3350, NF Powder for Oral Solution
17856-0962-3	2023-01-30	C162847	48780-1	f386c649-bd27-0266-e053-dadaa90a7c1a	Polyethylene Glycol 3350, NF Powder for Oral Solution
17856-0962-4	2023-01-30	C162847	48780-1	f386c649-bd27-0266-e053-dadaa90a7c1a	Polyethylene Glycol 3350, NF Powder for Oral Solution
17856-0962-5	2023-01-30	C162847	48780-1	f386c649-bd27-0266-e053-dadaa90a7c1a	Polyethylene Glycol 3350, NF Powder for Oral Solution

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
17856-0962-1	EA - Each	17856-0962	6ce26531-ef46-4e0a-a50d-64d078092554	1	2021-09-07
17856-0962-2	EA - Each	17856-0962	aa213cf6-523a-4e76-876a-2cf5f4e8fc84	1	2021-09-07
17856-0962-3	EA - Each	17856-0962	34e075a0-8703-41fe-b2d8-1fc08ba1dcc3	1	2021-09-07
17856-0962-4	EA - Each	17856-0962	0cac435c-32af-4c8c-b09d-98bd58dc5daf	1	2021-09-07
51991-962-57	GM - Gram	51991-962	c81a1d5c-2ee6-42f1-bea6-becc5c3ae4f5	1	2019-07-02

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
17856-0962	17856-0962-1, 17856-0962-2, 17856-0962-3, 17856-0962-4, 17856-0962-5
51991-962

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 44.

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
A090812-001	POLYETHYLENE GLYCOL 3350	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL			2009-10-07

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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`3a93d1ddd44b…`

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
b7c44b51-e393-4a5a-820b-756b08798400			4ef870f7-2f9f-4170-bc8d-6e9c52884c20	2024-06-04	Warnings	Exact identifier spl id: b7c44b51-e393-4a5a-820b-756b08798400 spl set id: 4ef870f7-2f9f-4170-bc8d-6e9c52884c20

Reported adverse events (FAERS/openFDA)#

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