FDA.reportPublic FDA data

Polyethylene Glycol 3350

Manufacturer
Marlex Pharmaceuticals Inc
Effective date
2019-05-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:59:29

Key Label Information#

Active Ingredients And Purpose

Active ingredient (in each dose)

Polyethylene Glycol 3350, 17 g (cap filled to line)

Purpose

Osmotic Laxative

Uses

Use

relieves occasional constipation (irregularity) generally produces a bowel movement in 1 to 3 days

Warnings

Warnings

Allergy alert: Do not use if you are allergic to polyethylene glycol

Directions And Dosage

Directions

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 Label Information

Inactive ingredient

none

Questions or comments?

1-800-FDA-1088 Manufactured for & Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE 19720 Rev. 04/19IT

PRINCIPAL DISPLAY PANEL

NDC 10135-0683-04 Polyethylene Glycol 3350 Powder for Solution, Osmotic Laxative Net Wt 4.1 oz (119 g) 7 Once-Daily Doses

PRINCIPAL DISPLAY PANEL

NDC 10135-0683-08 Polyethylene Glycol 3350 Powder for Solution, Osmotic Laxative Net Wt 8.3 oz (238 g) 14 Once-Daily Doses

Label Images#

polyethylene-glycol-3350-01
polyethylene-glycol-3350-01
polyethylene-glycol-3350-02
polyethylene-glycol-3350-02
polyethylene-glycol-3350-03
polyethylene-glycol-3350-03

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10135-683-042021-01-29C16284748780-1ba0f9c33-1230-a910-e053-dadaa90a0b85Polyethylene Glycol 3350
10135-683-082021-01-29C16284748780-1ba0f9c33-1230-a910-e053-dadaa90a0b85Polyethylene Glycol 3350
10135-683-122021-01-29C16284748780-1ba0f9c33-1230-a910-e053-dadaa90a0b85Polyethylene Glycol 3350

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-683-04Polyethylene Glycol 3350119 g in 1 BOTTLEPOWDER, FOR SOLUTION1192
10135-683-08Polyethylene Glycol 3350238 g in 1 BOTTLEPOWDER, FOR SOLUTION2382
10135-683-12Polyethylene Glycol 3350510 g in 1 BOTTLEPOWDER, FOR SOLUTION5102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-683POLYETHYLENE GLYCOL 3350 POWDER, FOR SOLUTION [MARLEX PHARMACEUTICALS INC]2Legacy NDC, 3 package rows20190518_5d2b2570-444b-4263-b339-bd81171979d6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-683-04GM - Gram10135-683b525cf0c-7183-4e9c-9e52-a662880619d912019-06-19
10135-683-08GM - Gram10135-683fa58e979-8efc-4b73-ac89-9e629457161812019-06-19
10135-683-12GM - Gram10135-683c61bfa76-3956-44d9-83df-158d29a42dc112019-06-19

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10135-68310135-683-04, 10135-683-08, 10135-683-12

Ingredients#

Name, UNII, Kind table
NameUNIIKind
POLYETHYLENE GLYCOL 3350G2M7P15E5PACTIB

Complete SPL Sections#

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

MARLEX PHARMACEUTICAL S , INC ---------- Polyethylene Glycol 3350 powder, for solution 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

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

SAFE HANDLING WARNING 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 for & Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE 19720 Rev. 04/19IT

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 10135-0683-04 Polyethylene Glycol 3350 Powder for Solution, Osmotic Laxative Net Wt 4.1 oz (119 g) 7 Once-Daily Doses

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 10135-0683-08 Polyethylene Glycol 3350 Powder for Solution, Osmotic Laxative Net Wt 8.3 oz (238 g) 14 Once-Daily Doses

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 10135-0683-12 Polyethylene Glycol 3350 Powder for Solution, Osmotic Laxative Net Wt 17.9 oz (510 g) 30 Once-Daily Doses

Source Document#

Source XML