Polyethylene Glycol 3350, NF Powder for Solution, Laxative

Manufacturer
Rebel Distributors Corp
Effective date
2010-12-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:27:53

Label at a glance#

ProductPolyethylene Glycol 3350, NF Powder for Solution, Laxative
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 cup designed to contain 17 grams of powder when filled to the top rim. adults and children 17 years of age and older fill to the top of the bottle cap which will provide the correct dose (17 g) stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink. use once a day use no more than 7 day...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Polyethylene Glycol 3350, 17g (cap filled to the top)

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

  • 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 a prescription drug

When using this product 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, 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed unless advised by your doctor
  • The bottle top is a measuring cup designed to contain 17 grams of powder when filled to the top rim.
  • adults and children 17 years of age and older
    • fill to the top of the bottle cap which will provide the correct dose (17 g)
    • stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink.
    • use once a day
    • use no more than 7 days
  • children 16 years of age or younger, ask a doctor

Other Information

SPL UNCLASSIFIED SECTION

  • Store at 20O - 25O C (68O - 77O 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

Questions or Comments?

SPL UNCLASSIFIED SECTION

For serious adverse events call: 

1-888-710-0006

Principal Display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Polyethylene Glycol 3350 NF
Polyethylene Glycol 3350 NF

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSN1
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCD1
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
POLYETHYLENE GLYCOL 3350 Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-598-252019-09-24C16284748780-1934fe258-487b-48b1-e053-8cdaa90a720aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-598-25Polyethylene Glycol 3350, NF Powder for Solution, Laxative255 g in 1 BOTTLEPOWDER, FOR SOLUTION2551

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-598POLYETHYLENE GLYCOL 3350, NF POWDER FOR SOLUTION, LAXATIVE POWDER, FOR SOLUTION [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110502_7546518f-b90f-477f-8f94-9ed76f98f1d7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-598-25GM - Gram21695-598baeaf50b-6dcd-4e96-b832-6a65524e980d12012-07-24
0722-7116-01GM - Gram0722-7116473bc880-16df-4d3b-a436-1b55a5f6f9da12012-07-24
0722-7116-02GM - Gram0722-7116597d615e-874a-429e-956c-cbfd90d0e20812012-07-24
0722-7116-03GM - Gram0722-7116bb77f060-d264-454f-a02b-58e8a83a882b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
POLYETHYLENE GLYCOL 3350ACTIVE INGREDIENTG2M7P15E5P1
POLYETHYLENE GLYCOL 3350ACTIVE MOIETYG2M7P15E5P1
AIRINACTIVE INGREDIENTK21NZZ5Y0B1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
21695-59821695-598-25
0722-7116

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYETHYLENE GLYCOL 3350G2M7P15E5PACTIB
AIRK21NZZ5Y0BIACT

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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090812-001POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-07

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-0784e616aacf4f…
2026-08-18 06:07:402026-07A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-0787673890dc5c…
2021-03-12 10:30 UTC2021-03A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-075aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-078869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-07c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-073f01610625f2…
2019-09-15 20:21 UTC2019-09A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-07b00525d2431f…
2019-07-19 19:46 UTC2019-07A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-07ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-073f0d92c62455…
2023-05-13 08:27 UTC2023-05A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-07053a50430f4f…
2023-01-26 05:58 UTC2023-01A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-073a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-07f41ea6bd6efb…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
7546518f-b90f-477f-8f94-9ed76f98f1d77546518f-b90f-477f-8f94-9ed76f98f1d72010-12-01WarningsExact identifier
spl id: 7546518f-b90f-477f-8f94-9ed76f98f1d7
spl set id: 7546518f-b90f-477f-8f94-9ed76f98f1d7

Reported adverse events (FAERS/openFDA)#

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