POLYTHYLENE GLYCOL

Manufacturer
DIRECT RX
Effective date
2023-09-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:26:15

Label at a glance#

ProductPOLYTHYLENE GLYCOL
Active ingredientPOLYETHYLENE GLYCOL 3350
Label structure11 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

Osmotic Laxative

USE IN SPECIFIC POPULATIONS SECTION

relieves occasional constipation (irregularity)
generally produces a bowel movement in 1 to 3 days

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.

SPL MEDGUIDE 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 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
use once a day
use no more than 7 days

children 16 years of age or younger: ask a doctor

OTHER SAFETY INFORMATION

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 INGREDIENT SECTION

none

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.

INDICATIONS & USAGE SECTION

relieves occasional constipation (irregularity)
generally produces a bowel movement in 1 to 3 days

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

067067

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-879-51GM - Gram61919-8792148fc5d-d816-43c4-9455-e6023eeecdc912022-10-06
51991-961-58GM - Gram51991-9612855f3fe-9049-4fe9-9179-0986247b277112019-07-02

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
61919-87961919-879-51
51991-961

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
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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-07c2088c7a36db…
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…

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
074ccc3d-5abd-3171-e063-6394a90a4ace9ab23521-8eeb-5740-e053-2a95a90a14112023-10-09WarningsExact identifier
spl set id: 9ab23521-8eeb-5740-e053-2a95a90a1411

Reported adverse events (FAERS/openFDA)#

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