FDA.reportPublic FDA data

Polyethylene Glycol 3350 powder for solution

Manufacturer
Harmon Stores, Inc | Strides Shasun Limited
Effective date
2017-05-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:49:54

Label at a glance#

ProductPolyethylene Glycol
Active ingredientPOLYETHYLENE GLYCOL 3350
Label structure12 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: 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...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each dose)

OTC - ACTIVE INGREDIENT SECTION

Polyethylene Glycol 3350, 17 g (cap filled to 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 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 of 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.

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:
    • 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
    • use once a day
    • use no more than 7 days
  • children 16 years of age or under: ask a doctor

Other information

ACCESSORIES

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

Inactive Ingredient

INACTIVE INGREDIENT SECTION

none

Questions or comments?

OTC - QUESTIONS SECTION

1-877-753-3935

Made in India

*Miralax® is a registered trademark of Bayer Consumer Care Holdings LLC

Distributed by Liberty

Procurement, Inc.650 Liberty

Ave. Union, NJ 07083 USA

Visit us at: www.facevalues.com

Revised: 01/2017

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 63940-762-03

Polyethylene Glycol 3350

Powder for Solution

OSMOTIC LAXATIVE

Polyethylene Glycol 3350 powder for solution increases frequency of bowel movements and softens the stool.

  • Relieves Occasional Constipation (Irregularity)
  • Softens Stool
  • Dissolves in any beverage
  • Sugar Free

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

7 Once-Daily Doses

NET WT 4.15 OZ (119 g)

peg-119g
peg-119g

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 63940-762-04

Polyethylene Glycol 3350

Powder for Solution

OSMOTIC LAXATIVE

Polyethylene Glycol 3350 powder for solution increases frequency of bowel movements and softens the stool.

  • Relieves Occasional Constipation (Irregularity)
  • Softens Stool
  • Dissolves in any beverage
  • Sugar Free

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

14 Once-Daily Doses

NET WT 8.3 OZ (238 g)

peg-238g
peg-238g

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 63940-762-05

Polyethylene Glycol 3350

Powder for Solution

OSMOTIC LAXATIVE

Polyethylene Glycol 3350 powder for solution increases frequency of bowel movements and softens the stool.

  • Relieves Occasional Constipation (Irregularity)
  • Softens Stool
  • Dissolves in any beverage
  • Sugar Free

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

30 Once-Daily Doses

NET WT 17.9 OZ (510 g)

peg-510g
peg-510g

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
63940-762-032020-01-31C16284748780-19d75b9d0-da17-f424-e053-dadaa90a57cePolyethylene Glycol 3350 powder for solution
63940-762-042020-01-31C16284748780-19d75b9d0-da17-f424-e053-dadaa90a57cePolyethylene Glycol 3350 powder for solution
63940-762-052020-01-31C16284748780-19d75b9d0-da17-f424-e053-dadaa90a57cePolyethylene Glycol 3350 powder for solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63940-762-03Polyethylene Glycol119 g in 1 BOTTLEPOWDER, FOR SOLUTION1191
63940-762-04Polyethylene Glycol238 g in 1 BOTTLEPOWDER, FOR SOLUTION2381
63940-762-05Polyethylene Glycol510 g in 1 BOTTLEPOWDER, FOR SOLUTION5101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63940-762POLYETHYLENE GLYCOL POWDER, FOR SOLUTION [HARMON STORES, INC]1Legacy NDC, 3 package rows20170522_3fd415b7-3d17-47ff-86b1-9eeac5f20271.zip

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63940-76263940-762-03, 63940-762-04, 63940-762-05

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
A203928-001POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-24
A203928-002POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-24

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A203928-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-2484e616aacf4f…
2026-09-14 22:38:342026-08A203928-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-2484e616aacf4f…
2026-08-18 06:07:402026-07A203928-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-24caaa826d4ba7…
2026-08-18 06:07:402026-07A203928-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203928-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203928-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203928-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203928-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A203928-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203928-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203928-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203928-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203928-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203928-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203928-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203928-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203928-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203928-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203928-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203928-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203928-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203928-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203928-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A203928-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203928-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203928-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203928-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203928-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203928-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203928-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203928-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-248072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203928-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203928-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-245c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203928-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203928-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-245d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203928-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203928-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-244b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203928-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203928-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-2474a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203928-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-2474a2ff9319b5…

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
6b9592f2-983d-462f-90a2-c288bc8f66573fd415b7-3d17-47ff-86b1-9eeac5f202712017-05-04WarningsExact identifier
spl id: 6b9592f2-983d-462f-90a2-c288bc8f6657
spl set id: 3fd415b7-3d17-47ff-86b1-9eeac5f20271

Reported adverse events (FAERS/openFDA)#

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