FDA.reportPublic FDA data

Polyethylene Glycol 3350 Powder for Oral Solution

Manufacturer
Aurohealth LLC | Aurobindo Pharma Limited | APL HEALTHCARE LIMITED
Effective date
2026-04-23
Label type
Human OTC Drug Label
Version
9
Source
full-release
Hydrated at
2026-06-01 01:54:58

Label at a glance#

ProductPolyethylene Glycol 3350
Active ingredientPOLYETHYLENE GLYCOL 3350
Label structure17 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: use once a day fill to top of white section in cap which is marked to indicate the correct dose (17g) stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperatu...

Storage and handling

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

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each dose)

Polyethylene Glycol 3350, USP 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

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
  • 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:
    • use once a day
    • fill to top of white section in cap which is marked to indicate the correct dose (17g)
    • stir and dissolve 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 seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken

Inactive ingredients

INACTIVE INGREDIENT SECTION

none

Questions or comments?
call 1-855-274-4122
Distributed by:
AUROHEALTH LLC
279 Princeton-Hightstown Road
East Windsor, NJ 08520

Made in India

Code: TS/DRUGS/16/2014


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 119 g Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AUROHEALTH

NDC 58602-805-01

Compare to active ingredient
of MiraLax®*

Polyethylene Glycol 3350
Powder for Oral Solution

Osmotic Laxative

  • Relieves Occasional Constipation/Irregularity
  • Softens Stool

UNFLAVORED POWDER - GRIT FREE

7 ONCE-DAILY DOSES        NET WT 4.1 OZ (119 g)
 
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 119 g Bottle LabelPACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 119 g Bottle Label
 

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 17 g Sachet Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AUROHEALTH

NDC 58602-805-26

Compare to active ingredient
of MiraLax®*

Polyethylene Glycol 3350
Powder for Oral Solution

Osmotic Laxative

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

UNFLAVORED POWDER - GRIT FREE

1 DOSE

NET WT 0.5 oz (17 g)

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

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AUROHEALTH

NDC 58602-805-27

Compare to active ingredient
of MiraLax®*

Polyethylene Glycol 3350
Powder for Oral Solution

Osmotic Laxative

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

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

14 ONCE-DAILY DOSES

UNFLAVORED POWDER - GRIT FREE

14 PRE-MEASURED, SINGLE DOSES

14 Packets
NET WT 0.5 oz
(17 g) Each

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSN9
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCD9
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSY9

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
POLYETHYLENE GLYCOL 3350 Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130358602805012GTIN-13: 0358602805012
EAN-13: 0358602805012
GTIN-12: 358602805012
UPC-A: 358602805012
GTIN storage (14 digits): 00358602805012		polyethylene-fig1.jpg

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
58602-805-01Polyethylene Glycol 3350119 g in 1 BOTTLE, PLASTICPOWDER, FOR SOLUTION1199
58602-805-02Polyethylene Glycol 3350238 g in 1 BOTTLE, PLASTICPOWDER, FOR SOLUTION2389
58602-805-03Polyethylene Glycol 3350510 g in 1 BOTTLE, PLASTICPOWDER, FOR SOLUTION5109
58602-805-04Polyethylene Glycol 3350850 g in 1 BOTTLE, PLASTICPOWDER, FOR SOLUTION8509
58602-805-25Polyethylene Glycol 3350765 g in 1 BOTTLE, PLASTICPOWDER, FOR SOLUTION7659
58602-805-27Polyethylene Glycol 335014 in 1 CARTONPOWDER, FOR SOLUTION149
58602-805-27Polyethylene Glycol 335017 g in 1 PACKETPOWDER, FOR SOLUTION179

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58602-805-01GM - Gram58602-805bd24f2da-2166-4913-9df7-578133273bb312026-02-05
58602-805-02GM - Gram58602-8054360bb71-2e9b-4227-a40d-63e3d70c99e812026-02-05
58602-805-03GM - Gram58602-805d36efcb9-552e-41d6-9ec5-959ef1f324d112026-02-05
58602-805-27EA - Each58602-805f2ce425f-025f-4c82-8484-e5c367b8c19212026-02-05

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
58602-80558602-805-01, 58602-805-02, 58602-805-03, 58602-805-04, 58602-805-25, 58602-805-27

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
82025-09-11monthly-update2026-06-03 17:39:10
72025-05-08full-release2026-06-01 01:01:01

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 3350Aurohealth LLCd3c77f3f-57aa-4e2d-88aa-731cbb22af702026-04-23WarningsExact identifier
ndc (package): 58602-805-25
ndc (package): 58602-805-03
ndc (package): 58602-805-27
ndc (package): 58602-805-04
ndc (package): 58602-805-01
ndc (package): 58602-805-02
ndc (product): 58602-805
ndc11 (package): 58602080502
ndc11 (package): 58602080503
ndc11 (package): 58602080525
ndc11 (package): 58602080501
ndc11 (package): 58602080504
ndc11 (package): 58602080527
spl id: af3011d1-9e74-42f2-bbc8-8f08c45898ea
spl set id: d3c77f3f-57aa-4e2d-88aa-731cbb22af70

Reported adverse events (FAERS/openFDA)#

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