Drug Facts

Manufacturer
Mylan Institutional Inc.
Effective date
2026-04-08
Label type
HUMAN OTC DRUG LABEL
Version
16
Source
full-release
Hydrated at
2026-06-01 01:53:50

Label at a glance#

ProductPolyethylene Glycol (3350)
Active ingredientPOLYETHYLENE GLYCOL 3500
Label structure16 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 the contents of one pouch (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 no drink if there...

Label contents#

Full prescribing information#

Active ingredient (in each dose)

OTC - ACTIVE INGREDIENT SECTION

Polyethylene Glycol 3350, USP, 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

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 the contents of one pouch (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 no 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 pouch is damaged or torn
  • for institutional use only

Inactive ingredients

INACTIVE INGREDIENT SECTION

none

Questions or comments?

OTC - QUESTIONS SECTION

1-877-4-INFO-RX (1-877-446-3679)

Distributed by:
Mylan Pharmaceuticals Inc.,
a Viatris Company

Rockford, IL 61103 U.S.A.
Viatris.com

MII306-30:R9

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 51079-306-30

Polyethylene Glycol 3350, USP
Powder for Solution,
Osmotic Laxative

  • Relieves Occasional Constipation/Irregularity
  • Softens Stool

 

  • Unflavored
  • Powder
  • Grit Free
  • Sugar Free
  • Dissolves in Any Beverage

This carton contains 30 single-dose pouches.
Each pouch contains 17 grams of
polyethylene glycol 3350, USP powder.

30 Single-Dose Pouches
For institutional use only.

Drug Facts

Active ingredient (in each dose)     Purpose

Polyethylene Glycol 3350, USP, 17 g . . . . . . . . . Osmotic Laxative

Use

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

Warnings

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

Drug Facts (continued)

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

  • 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 the contents of one pouch (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

  • store at 20° to 25°C (68° to 77°F)
  • tamper-evident: do not use if pouch is damaged or torn

Inactive ingredients     none

Questions or comments?

1-877-4-INFO-RX (1-877-446-3679)

Distributed by:
Mylan Pharmaceuticals Inc.,
a Viatris Company
Rockford, IL 61103 U.S.A.

Viatris.com

Polyethylene Glycol 3350 Carton Label
Polyethylene Glycol 3350 Carton Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSN16
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCD16
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSY16

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51079-306-01Polyethylene Glycol (3350)17 g in 1 POUCHPOWDER, FOR SOLUTION1716
51079-306-30Polyethylene Glycol (3350)30 in 1 CARTONPOWDER, FOR SOLUTION3016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51079-306-01EA - Each51079-3066edd47d6-585c-4aec-9825-167d6c26d04812012-07-24
51079-306-30EA - Each51079-30664c4049d-cf71-4b4d-85d3-81506f8bc6f412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
POLYETHYLENE GLYCOL 3500ACTIVE INGREDIENTFVS1AZD90Y2
POLYETHYLENE GLYCOL 3500ACTIVE MOIETYFVS1AZD90Y2

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
51079-30651079-306-01, 51079-306-30

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 3500FVS1AZD90YACTIB

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
A078915-001POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-06
A078915-002POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06

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 22:38:342026-08A078915-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-0684e616aacf4f…
2026-09-14 22:38:342026-08A078915-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-0684e616aacf4f…
2026-08-18 06:07:402026-07A078915-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-06caaa826d4ba7…
2026-08-18 06:07:402026-07A078915-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078915-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078915-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078915-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078915-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A078915-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078915-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078915-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078915-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078915-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078915-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078915-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078915-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078915-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078915-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078915-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078915-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078915-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078915-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078915-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A078915-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078915-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078915-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078915-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078915-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078915-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078915-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078915-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-068072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078915-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078915-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-065c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078915-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078915-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-065d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078915-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078915-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-064b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078915-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078915-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-0674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078915-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-0674a2ff9319b5…

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 (3350)POLYETHYLENE GLYCOL (3350)Mylan Institutional Inc.219bcbc4-b84a-4209-9f34-ef2b0ef0d2732026-04-08WarningsExact identifier
ndc (package): 51079-306-01
ndc (package): 51079-306-30
ndc (product): 51079-306
ndc11 (package): 51079030630
ndc11 (package): 51079030601
spl id: e67ef7f0-6cb2-4f99-b29c-e4f122e2e250
spl set id: 219bcbc4-b84a-4209-9f34-ef2b0ef0d273

Reported adverse events (FAERS/openFDA)#

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