FDA.reportPublic FDA data

Major 44-726

Manufacturer
Major Pharmaceuticals | LNK International, Inc.
Effective date
2026-05-12
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 01:58:39

Key Label Information#

Active Ingredients And Purpose

Active ingredient (in each dose)

Polyethylene Glycol 3350, 17 g

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 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 Label Information

Other information

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

Inactive ingredients

none

Questions or comments?

1-800-616-2471

Principal display panel

NDC 0904-6931-26 Compare to MiraLAX® active ingredient* MAJOR® PEG 3350 Polyethylene Glycol 3350 Powder for Oral Solution Osmotic Laxative • Relieves Occasional Constipation (Irregularity) • Softens Stool Dissolves in Any Beverage Sugar Free Unflavored 14 Once-Daily Doses NET WT 0.5 OZ (17 g) Each TAMPER-EVIDENT: DO NOT USE IF FOIL IS OPEN OR BROKEN *This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark MiraLAX®. Distributed by MAJOR® PHARMACEUTICALS Indianapolis, IN 46268 www.majorpharmaceuticals.com Rev. 03/22 M-17 Re-order No. 701066 Product of India 50844 REV0222D72648 Major 44-726

Label Images#

major-44-726-1
major-44-726-1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSN11
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCD11
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSY11

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
0904-6931-26Polyethylene glycol 335014 in 1 CARTONPOWDER, FOR SOLUTION1411
0904-6931-26Polyethylene glycol 335017 g in 1 PACKETPOWDER, FOR SOLUTION1711
0904-6931-76Polyethylene glycol 335030 in 1 CARTONPOWDER, FOR SOLUTION3011
0904-6931-76Polyethylene glycol 335017 g in 1 PACKETPOWDER, FOR SOLUTION1711
0904-6931-81Polyethylene glycol 335017 g in 1 PACKETPOWDER, FOR SOLUTION1711
0904-6931-81Polyethylene glycol 3350100 in 1 CARTONPOWDER, FOR SOLUTION10011
0904-6931-86Polyethylene glycol 335017 g in 1 PACKETPOWDER, FOR SOLUTION1711

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6931-26EA - Each0904-693122b98f39-66d0-475e-b5bc-566b492c5f6012020-08-06
0904-6931-76EA - Each0904-6931ea58d86a-7b36-4de8-a842-48a47ffdf5c812020-03-10
0904-6931-81EA - Each0904-6931fbacfb5a-1498-4fcf-9bdf-ab1a70b8cc6d12020-04-20
0904-6931-86EA - Each0904-6931eb1bce8f-e443-42aa-a484-d8f8448a73b212020-03-10

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0904-69310904-6931-86, 0904-6931-26, 0904-6931-76, 0904-6931-81

Ingredients#

Name, UNII, Kind table
NameUNIIKind
POLYETHYLENE GLYCOL 3350G2M7P15E5PACTIB

Complete SPL Sections#

Active ingredient (in each dose)

OTC - ACTIVE INGREDIENT SECTION

Polyethylene Glycol 3350, 17 g

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 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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

none

Questions or comments?

OTC - QUESTIONS SECTION

1-800-616-2471

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0904-6931-26 Compare to MiraLAX® active ingredient* MAJOR® PEG 3350 Polyethylene Glycol 3350 Powder for Oral Solution Osmotic Laxative • Relieves Occasional Constipation (Irregularity) • Softens Stool Dissolves in Any Beverage Sugar Free Unflavored 14 Once-Daily Doses NET WT 0.5 OZ (17 g) Each TAMPER-EVIDENT: DO NOT USE IF FOIL IS OPEN OR BROKEN *This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark MiraLAX®. Distributed by MAJOR® PHARMACEUTICALS Indianapolis, IN 46268 www.majorpharmaceuticals.com Rev. 03/22 M-17 Re-order No. 701066 Product of India 50844 REV0222D72648 Major 44-726

Source Document#

Source XML