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

Label at a glance#

ProductPolyethylene glycol 3350
Active ingredientPOLYETHYLENE GLYCOL 3350
Label structure9 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...

Storage and handling

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

Label contents#

Full prescribing information#

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

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 get diarrhea
  • you need to use a laxative for longer than 1 week
  • you have rectal bleeding or your nausea, bloating, cramping or abdominal pain gets worse. These may be signs of a serious condition.

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

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®

PEG3350

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
Major 44-726

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

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
0904-69310904-6931-86, 0904-6931-26, 0904-6931-76, 0904-6931-81

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 44.

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 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A203928-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-24c2088c7a36db…
2026-10-15 13:18:302026-09A203928-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-24c2088c7a36db…
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…

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 3350Major Pharmaceuticalsddc9d2b1-87d8-44fa-bac6-0a7261f335642026-05-12WarningsExact identifier
ndc (package): 0904-6931-26
ndc (package): 0904-6931-76
ndc (package): 0904-6931-81
ndc (package): 0904-6931-86
ndc (product): 0904-6931
ndc11 (package): 00904693186
ndc11 (package): 00904693181
ndc11 (package): 00904693126
ndc11 (package): 00904693176
spl id: d804d78d-bf7c-4ae2-a3a7-d1e7337bbeb8
spl set id: ddc9d2b1-87d8-44fa-bac6-0a7261f33564

Reported adverse events (FAERS/openFDA)#

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