Polyethylene Glycol 3350

Manufacturer
The Fresh Test, LLC | Strides Pharma Global Pte. Ltd.
Effective date
2026-08-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-08-08 02:02:31

Label at a glance#

ProductPolyethylene Glycol 3350
Active ingredientPOLYETHYLENE GLYCOL 3350
Label structure11 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 (17 g) stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperat...

Label contents#

Full prescribing information#

Polyethylene Glycol 3350, Powder for Solution

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each dose)

OTC - ACTIVE INGREDIENT SECTION

Polyethylene Glycol 3350, 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

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

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
  • 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 (17 g)
    • 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

HOW SUPPLIED SECTION

  • store at 20° - 25°C (68° - 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?

OTC - QUESTIONS SECTION

424-353-7889

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

Manufactured by:

Strides Pharma Science Limited

Bengaluru – 5562106, India.

Distributed by

Fresh Test, LLC

Los Angeles CA 90066

Revised:03/2026

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 87362-119-01

Polyethylene Glycol 3350

Unflavored Powder for Solution

Osmotic Laxative

  • Relieves Occasional Constipation /Irregularity
  • Softens Stool

TAMPER-EVIDENT: DO NOT USE IF PRINTED FOIL SEAL UNDER CAP IS MISSING, OPEN OR BROKEN

  • Unflavored
  • Sugar Free
  • Dissolves in Any Beverage

7 ONCE-DAILY DOSES

NET WT 4.15 OZ (119 g)

119 g CAN - FRONT
119 g CAN - FRONT
119 g BASE LABEL
119 g BASE LABEL
119g BACK LABEL-1
119g BACK LABEL-1
119g BACK LABEL-2
119g BACK LABEL-2

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130387362119015GTIN-13: 0387362119015
EAN-13: 0387362119015
GTIN-12: 387362119015
UPC-A: 387362119015
GTIN storage (14 digits): 00387362119015
50ea60c2-f393-4ba3-bbee-7bf165de33ed-14.jpg
Data codeData Matrix553350ea60c2-f393-4ba3-bbee-7bf165de33ed-12.jpg

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
87362-11987362-119-01

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 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
A203928-001POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-24
A203928-002POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-24

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 22:38:342026-08A203928-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-2484e616aacf4f…
2026-09-14 22:38:342026-08A203928-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-2484e616aacf4f…
2026-08-18 06:07:402026-07A203928-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-24caaa826d4ba7…
2026-08-18 06:07:402026-07A203928-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203928-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203928-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203928-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203928-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A203928-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203928-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203928-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203928-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203928-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203928-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203928-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203928-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203928-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203928-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203928-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203928-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203928-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203928-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203928-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A203928-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203928-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203928-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203928-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203928-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203928-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203928-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203928-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-248072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203928-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203928-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-245c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203928-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203928-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-245d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203928-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203928-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-244b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203928-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203928-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-2474a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203928-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-2474a2ff9319b5…

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 3350The Fresh Test, LLCcb8e182f-c23f-4f8d-9c09-24e19b2e914e2026-08-05WarningsExact identifier
ndc (package): 87362-119-01
ndc (product): 87362-119
ndc11 (package): 87362011901
spl id: 50ea60c2-f393-4ba3-bbee-7bf165de33ed
spl set id: cb8e182f-c23f-4f8d-9c09-24e19b2e914e

Reported adverse events (FAERS/openFDA)#

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