Polyethylene Glycol 3350

Manufacturer
SKY Packaging
Effective date
2025-05-14
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:00:54

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 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...

Label contents#

Full prescribing information#

Active Ingredient (in each dose)

OTC - ACTIVE INGREDIENT SECTION

Polyethylene Glycol 3350 USP, 17g

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:

SPL UNCLASSIFIED SECTION

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 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

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

None

Questions or comments?

OTC - QUESTIONS SECTION

1-888-243-4363

SPL UNCLASSIFIED SECTION

Packaged by:
Novitium Pharma LLC
East Windsor, NJ 08520

Distributed by:
McKesson Corporation dba SKY Packaging
Memphis, TN 38141

Issued: 05/2024

LB4717-00

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 63739-760-03
Polyethylene Glycol 3350
Powder for Solution,
Osmotic Laxative

  • Relieves Occasional Constipation/Irregularity
  • Softens Stool

Dissolves in any Beverage
Sugar free

30 Once-Daily Doses
30 Packets NET WT 0.5 oz (17 g) Each

30 Single Doses

Compare to MiraLAX ®Active Ingredient
peg_cartonpeg_carton

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
63739-760-01Polyethylene Glycol 335017 g in 1 PACKETPOWDER, FOR SOLUTION175
63739-760-02Polyethylene Glycol 335014 in 1 CARTONPOWDER, FOR SOLUTION145
63739-760-03Polyethylene Glycol 335030 in 1 CARTONPOWDER, FOR SOLUTION305
63739-760-04Polyethylene Glycol 3350100 in 1 CARTONPOWDER, FOR SOLUTION1005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63739-760POLYETHYLENE GLYCOL 3350 POWDER, FOR SOLUTION [SKY PACKAGING]54 package rows20250515_173a62cb-9b20-4b50-e063-6294a90ac36b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63739-760-01EA - Each63739-7609b1db098-df7f-4abf-9799-84881eaa303c12024-08-12
63739-760-02EA - Each63739-7600dcbdd38-5795-4a94-a9fc-40c2225e128c12024-08-12
63739-760-03EA - Each63739-760a3dca200-7355-478d-b728-378f80fec56412024-11-05
63739-760-04EA - Each63739-7600ecc35c9-cc15-4806-b2be-f9adeb92db9d12024-09-09

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
63739-76063739-760-01, 63739-760-03, 63739-760-04, 63739-760-02

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

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
3516c167-5589-2050-e063-6294a90a6942173a62cb-9b20-4b50-e063-6294a90ac36b2025-05-14WarningsExact identifier
spl id: 3516c167-5589-2050-e063-6294a90a6942
spl set id: 173a62cb-9b20-4b50-e063-6294a90ac36b

Reported adverse events (FAERS/openFDA)#

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