FDA.reportPublic FDA data

Polyethylene Glycol 3350

Manufacturer
ANI Pharmaceuticals, Inc.
Effective date
2025-12-10
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:20:48

Label at a glance#

ProductPolyethylene Glycol 3350
Active ingredientPOLYETHYLENE GLYCOL 3350
Label structure17 sections

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 packet 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...

Label contents#

Full prescribing information#

Active Ingredient (in each dose)

OTC - ACTIVE INGREDIENT SECTION

Polyethylene Glycol 3350 USP, 17g

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

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 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.

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 packet 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° to 25°C (68° to 77°F)
  • tamper-evident: do not use if printed foil pouch is open or broken

Inactive ingredients

INACTIVE INGREDIENT SECTION

None

Questions or comments?

OTC - QUESTIONS SECTION

1-855-204-1431

SPL UNCLASSIFIED SECTION

Distributed by:
ANI Pharmaceuticals, Inc.
Baudette, MN 56623

10198 Rev 04/25

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 62559-157-30
Polyethylene Glycol 3350
Powder for Solution,
Osmotic Laxative

  • Relieves Occasional Constipation/Irregularity
  • Softens Stool

Dissolves in any Beverage
Sugar free

30 Once-Daily Doses
30 Packets NET WT 0.5 oz (17 g) Each
30 Single Doses
Compare to MiraLAX® Active Ingredient
Carton-30pktCarton-30pkt

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSN8
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCD8
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSY8

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62559-157-10Polyethylene Glycol 3350100 in 1 CARTONPOWDER, FOR SOLUTION1008
62559-157-17Polyethylene Glycol 335017 g in 1 PACKETPOWDER, FOR SOLUTION178
62559-157-30Polyethylene Glycol 335030 in 1 CARTONPOWDER, FOR SOLUTION308

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62559-157-10EA - Each62559-157b68bdddd-f9cc-4703-bd00-3ea7d384f95d12020-04-20
62559-157-30EA - Each62559-15708831411-fd0b-47a9-bfa5-6742dde443c012020-04-20

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62559-15762559-157-17, 62559-157-30, 62559-157-10

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
NameUNIIKind
POLYETHYLENE GLYCOL 3350G2M7P15E5PACTIB

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202850-001POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2015-12-15
A202850-002POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2021-11-30

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 · 48 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A202850-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2015-12-1584e616aacf4f…
2026-09-14 22:38:342026-08A202850-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2021-11-3084e616aacf4f…
2026-08-18 06:07:402026-07A202850-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2015-12-15caaa826d4ba7…
2026-08-18 06:07:402026-07A202850-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2021-11-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202850-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2015-12-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202850-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2021-11-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202850-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2015-12-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202850-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2021-11-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A202850-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2015-12-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202850-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2015-12-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202850-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2015-12-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202850-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2015-12-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202850-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2015-12-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202850-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2015-12-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202850-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2015-12-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202850-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2015-12-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202850-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2015-12-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202850-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2015-12-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202850-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2015-12-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202850-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2015-12-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202850-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2015-12-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202850-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2015-12-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202850-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2015-12-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202850-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2015-12-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202850-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2015-12-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202850-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2015-12-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202850-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2015-12-1587673890dc5c…
2021-03-12 10:30 UTC2021-03A202850-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2015-12-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202850-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2015-12-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202850-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2015-12-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202850-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2015-12-153f01610625f2…
2019-09-15 20:21 UTC2019-09A202850-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2015-12-15b00525d2431f…
2019-07-19 19:46 UTC2019-07A202850-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2015-12-15ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202850-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2015-12-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202850-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2015-12-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202850-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2015-12-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202850-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2015-12-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202850-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2015-12-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202850-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2015-12-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202850-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2015-12-153f0d92c62455…

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
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350ANI Pharmaceuticals, Inc.1afff730-b2d3-4e01-8403-97f2ecef3a742025-12-10WarningsExact identifier
ndc (package): 62559-157-30
ndc (package): 62559-157-10
ndc (package): 62559-157-17
ndc (product): 62559-157
ndc11 (package): 62559015717
ndc11 (package): 62559015730
ndc11 (package): 62559015710
spl id: 62f5ef8d-cbde-464f-8dd6-c087053dfd42
spl set id: 1afff730-b2d3-4e01-8403-97f2ecef3a74

Reported adverse events (FAERS/openFDA)#

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