FDA.reportPublic FDA data

Polyethylene Glycol 3350 powder, for solution

Manufacturer
Woodward Pharma Services LLC | Future Pak, Ltd.
Effective date
2022-07-29
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:56:04

Label at a glance#

ProductPOLYETHYLENE GLYCOL 3350 NF
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: ○ stir and dissolve one packet 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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Polyethylene Glycol 3350, 17 g

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

SPL UNCLASSIFIED SECTION

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 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:

    ○ stir and dissolve one packet 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

SPL UNCLASSIFIED SECTION

  • store at 20° - 25°C (68° - 77°F)
  • tamper- evident: do not use if printed foil pouch is open or broken

Inactive ingredient

INACTIVE INGREDIENT SECTION

none

Questions or comments?

OTC - QUESTIONS SECTION

1-888-514-4727

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69784-180-01

Compare to MiraLAX®

Original Prescription Strength

PEG3350

Polyethylene Glycol 3350

Powder for Oral Solution, Osmotic Laxative

Relieves Occasional Constipation (irregularity)

Softens Stool

NET WT 0.5 OZ (17gm)

1 DOSE

2ffddd92-figure-032ffddd92-figure-03

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69784-180-14

Compare to MiraLAX®

Original Prescription Strength

PEG3350

Polyethylene Glycol 3350

Powder for Oral Solution, Osmotic Laxative

Relieves Occasional Constipation (irregularity)

Softens Stool

14 ct Unit-Dose Packets
0.5 OZ (17 gm) each

2ffddd92-figure-032ffddd92-figure-03

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69784-180-102022-07-31C16284748780-1d6a99b39-5d22-a426-e053-dadaa90af4c2Polyethylene Glycol 3350 powder, for solution
69784-180-142022-07-31C16284748780-1d6a99b39-5d22-a426-e053-dadaa90af4c2Polyethylene Glycol 3350 powder, for solution
69784-180-302022-07-31C16284748780-1d6a99b39-5d22-a426-e053-dadaa90af4c2Polyethylene Glycol 3350 powder, for solution
69784-180-102022-01-28C16284748780-1d6a99b39-5d22-a426-e053-dadaa90af4c2Polyethylene Glycol 3350 powder, for solution
69784-180-142022-01-28C16284748780-1d6a99b39-5d22-a426-e053-dadaa90af4c2Polyethylene Glycol 3350 powder, for solution
69784-180-302022-01-28C16284748780-1d6a99b39-5d22-a426-e053-dadaa90af4c2Polyethylene Glycol 3350 powder, for solution

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69784-180POLYETHYLENE GLYCOL 3350 NF (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [WOODWARD PHARMA SERVICES LLC]5Legacy NDC20220801_657a51f5-f12f-4b7a-b8fa-2d75d7289f2a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69784-180-01EA - Each69784-18078a4e98c-5116-4332-b705-d475b856ff3c12018-08-13
69784-180-10EA - Each69784-1805b11c9f7-84fb-4be9-b8cd-32129bdb348112018-09-05
69784-180-14EA - Each69784-1809abf5ff4-e079-4b71-a8e6-b2b50bdea1c512018-09-05
69784-180-30EA - Each69784-18025e8da83-8418-4c5c-98e3-ce4cf2b7354b12018-12-13
11534-180-19GM - Gram11534-18073b4d364-9253-4269-9fd3-1f5fc3aeaab012018-12-13
11534-180-28GM - Gram11534-1802718a569-b762-40d2-811b-3db3feb6fe7a12017-08-11
11534-180-50GM - Gram11534-1803d141a0c-b9a4-42c1-98aa-de9e7c90828312018-06-11

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
69784-18069784-180-01, 69784-180-14, 69784-180-30, 69784-180-10
11534-180

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 44.

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
A206105-001POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-28

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-28c2088c7a36db…
2026-09-14 22:38:342026-08A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-2884e616aacf4f…
2026-08-18 06:07:402026-07A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-283f01610625f2…
2019-09-15 20:21 UTC2019-09A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-283a93d1ddd44b…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
04bcf286-b374-4c28-a20e-e7ac54f10467657a51f5-f12f-4b7a-b8fa-2d75d7289f2a2025-09-18WarningsExact identifier
spl set id: 657a51f5-f12f-4b7a-b8fa-2d75d7289f2a
POLYETHYLENE GLYCOL 3350 NFPOLYETHYLENE GLYCOL 3350SUNRISE PHARMACEUTICAL, INCce5197a1-2677-4ffb-aef2-9221b28ebd232020-01-22WarningsExact identifier
ndc (product): 11534-180

Reported adverse events (FAERS/openFDA)#

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