FDA.reportPublic FDA data

Polyethylene Glycol 3350 Powder for Oral Solution

Manufacturer
CARDINAL HEALTH 110, LLC. DBA LEADER | Aurohealth LLC | Aurobindo Pharma Limited | APL HEALTHCARE LIMITED
Effective date
2026-04-23
Label type
Human OTC Drug Label
Version
5
Source
full-release
Hydrated at
2026-06-01 01:55:03

Label at a glance#

ProductPOLYETHYLENE GLYCOL 3350
Active ingredientPOLYETHYLENE GLYCOL 3350
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 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...

Storage and handling

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

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each dose)

Polyethylene Glycol 3350, USP 17 grams

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

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

  • nausea, vomiting or abdominal pain
  • a sudden change in bowel habits that lasts over 2 weeks
  • irritable bowel syndrome

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking a prescription drug

OTC - WHEN USING SECTION

When using this product 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, 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 (1-800-222-1222) 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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

none

Questions or comments?
call 1-855-274-4122
DISTRIBUTED BY
CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com  1-800-200-6313
Essential to Care™ since 1979

Made in India

Code: TS/DRUGS/16/2014

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 17 g Pouch Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADERTM

NDC 70000-0699-1

Grit-Free | Unflavored Powder Packet
Polyethylene
Glycol 3350
Powder for Oral Solution
Osmotic Laxative

Relieves Occasional
Constipation/Irregularity
Softens Stool
Sugar-Free
Dissolves in any Beverage

COMPARE TO
MiraLAX®
active ingredient*

100% Money
Back Guarantee

1 DOSE
NET WT 0.5 OZ (17g)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 17 g Pouch LabelPACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 17 g Pouch Label

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 17 g Pouch Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADERTM

NDC 70000-0699-2

Grit-Free | Unflavored Powder Packets
Polyethylene Glycol 3350
Powder for Oral Solution | Osmotic Laxative

Relieves Occasional Constipation/Irregularity
Softens Stool
Sugar-Free
Dissolves in Any Beverage

COMPARE TO
MiraLAX®
active ingredient*

100% Money
Back Guarantee

10 PRE-MEASURED, SINGLE DOSES                            10 PACKETS
10 ONCE-DAILY DOSES                                                    NET WT 0.5 OZ (17g) EACH

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 17 g Pouch Carton LabelPACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 17 g Pouch Carton Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSN5
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCD5
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSY5

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
70000-0699-1POLYETHYLENE GLYCOL 335017 g in 1 PACKETPOWDER, FOR SOLUTION175
70000-0699-2POLYETHYLENE GLYCOL 335010 in 1 CARTONPOWDER, FOR SOLUTION105

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
70000-069970000-0699-1, 70000-0699-2

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

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42025-12-12monthly-update2026-06-03 17:53:04

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
A209017-001POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2018-04-09
A209017-002POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2024-04-23

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 22:38:342026-08A209017-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2018-04-0984e616aacf4f…
2026-09-14 22:38:342026-08A209017-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2024-04-2384e616aacf4f…
2026-08-18 06:07:402026-07A209017-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2018-04-09caaa826d4ba7…
2026-08-18 06:07:402026-07A209017-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2024-04-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209017-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2018-04-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209017-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2024-04-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209017-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2018-04-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209017-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2024-04-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A209017-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2018-04-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209017-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2018-04-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209017-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2018-04-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209017-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2018-04-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209017-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2018-04-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209017-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2018-04-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209017-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2018-04-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209017-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2018-04-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209017-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2018-04-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209017-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2018-04-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209017-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2018-04-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209017-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2018-04-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209017-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2018-04-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209017-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2018-04-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209017-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2018-04-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209017-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2018-04-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209017-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2018-04-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209017-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2018-04-09782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209017-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2018-04-0987673890dc5c…
2021-03-12 10:30 UTC2021-03A209017-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2018-04-095aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209017-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2018-04-098869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209017-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2018-04-09c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209017-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2018-04-093f01610625f2…
2019-09-15 20:21 UTC2019-09A209017-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2018-04-09b00525d2431f…
2019-07-19 19:46 UTC2019-07A209017-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2018-04-09ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209017-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2018-04-096a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209017-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2018-04-091c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209017-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2018-04-09ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209017-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2018-04-09a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209017-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2018-04-099b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209017-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2018-04-09a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209017-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2018-04-093f0d92c62455…

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 3350CARDINAL HEALTH 110, LLC. DBA LEADER04cc4f2e-1725-4710-8cfb-73a6bdf52e4f2026-04-23WarningsExact identifier
ndc (package): 70000-0699-1
ndc (package): 70000-0699-2
ndc (product): 70000-0699
ndc11 (package): 70000069902
ndc11 (package): 70000069901
spl id: 048ca2e6-2e71-49f6-81b5-0e34a8f36b77
spl set id: 04cc4f2e-1725-4710-8cfb-73a6bdf52e4f

Reported adverse events (FAERS/openFDA)#

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