FDA.reportPublic FDA data

Polyethylene Glycol 3350 powder, for solution

Manufacturer
SUNRISE PHARMACEUTICAL, INC | SUNRISE PHARMACEUTICAL INC.
Effective date
2020-01-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:03:24

Label at a glance#

ProductPOLYETHYLENE GLYCOL 3350 NF
Active ingredientPOLYETHYLENE GLYCOL 3350
Label structure16 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 (clear section in cap) adults and children 17 years of age and older: ○ fill to top of clear 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 d...

Label contents#

Full prescribing information#

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

SPL UNCLASSIFIED SECTION

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 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 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
  • the bottle top is a measuring cap marked to contain 17 grams of powder when filled to the indicated line (clear section in cap)
  • adults and children 17 years of age and older:

    ○ fill to top of clear 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

    ○ use once a day

    ○ use no more than 7 days

  • children 16 years of age or under: ask a doctor

Other information

SPL UNCLASSIFIED 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 ingredient

INACTIVE INGREDIENT SECTION

none

Questions or comments?

OTC - QUESTIONS SECTION

1-800-FDA-1088

Manufactured & Distributed by:
Sunrise Pharmaceutical, Inc.
Rahway, NJ 07065

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 11534-180-19

Polyethylene Glycol

3350

Powder for Solution, Osmotic Laxative

  • Relieves Occasional

    Constipation/Irregularity

  • Softens Stool
  • Dissolves in Any Beverage

    Unflavored Powder Grit Free

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

    2ffddd92-figure-012ffddd92-figure-01

    NDC 11534-180-28

    Polyethylene Glycol

    3350

    Powder for Solution, Osmotic Laxative

  • Relieves Occasional

    Constipation/Irregularity

  • Softens Stool
  • Dissolves in Any Beverage

    Unflavored Powder Grit Free

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

    2ffddd92-figure-022ffddd92-figure-02

    NDC 11534-180-50

    Polyethylene Glycol

    3350

    Powder for Solution, Osmotic Laxative

  • Relieves Occasional

    Constipation/Irregularity

  • Softens Stool
  • Dissolves in Any Beverage

  • Unflavored Powder Grit Free

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

  • 2ffddd92-figure-032ffddd92-figure-03

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSN2
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCD2
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSY2

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
11534-180-19POLYETHYLENE GLYCOL 3350 NF119 g in 1 BOTTLEPOWDER, FOR SOLUTION1192
11534-180-28POLYETHYLENE GLYCOL 3350 NF238 g in 1 BOTTLEPOWDER, FOR SOLUTION2382
11534-180-50POLYETHYLENE GLYCOL 3350 NF510 g in 1 BOTTLEPOWDER, FOR SOLUTION5102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11534-180POLYETHYLENE GLYCOL 3350 NF (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [SUNRISE PHARMACEUTICAL, INC]2Current NDC, Legacy NDC, 3 package rows20200123_ce5197a1-2677-4ffb-aef2-9221b28ebd23.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11534-180-19GM - Gram11534-18073b4d364-9253-4269-9fd3-1f5fc3aeaab012018-12-13
11534-180-28GM - Gram11534-1802718a569-b762-40d2-811b-3db3feb6fe7a12017-08-11
11534-180-50GM - Gram11534-1803d141a0c-b9a4-42c1-98aa-de9e7c90828312018-06-11

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
11534-18011534-180-19, 11534-180-28, 11534-180-50

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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206105-001POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-28

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-2884e616aacf4f…
2026-08-18 06:07:402026-07A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-283f01610625f2…
2019-09-15 20:21 UTC2019-09A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A206105-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-10-28f41ea6bd6efb…

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 NFPOLYETHYLENE GLYCOL 3350SUNRISE PHARMACEUTICAL, INCce5197a1-2677-4ffb-aef2-9221b28ebd232020-01-22WarningsExact identifier
ndc (package): 11534-180-50
ndc (package): 11534-180-19
ndc (package): 11534-180-28
ndc (product): 11534-180
ndc11 (package): 11534018050
ndc11 (package): 11534018019
ndc11 (package): 11534018028
spl id: 020b7f87-0f3a-4223-a402-dea12a6c53d2
spl set id: ce5197a1-2677-4ffb-aef2-9221b28ebd23

Reported adverse events (FAERS/openFDA)#

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