Major 44-726

Manufacturer
Cardinal Health 107, LLC
Effective date
2026-06-19
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
weekly-update
Hydrated at
2026-07-17 21:41:52

Label at a glance#

ProductPolyethylene glycol 3350
Active ingredientPOLYETHYLENE GLYCOL 3350
Label structure10 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...

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

.

SPL UNCLASSIFIED SECTION

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

Overbagged with 10 packets per bag, NDC 55154-8091-5

WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.

Distributed By:

Cardinal Health

Dublin, OH 43017

L56118351223

Rev. 03/22 M-17 Re-order No. 701066

Product of India 50844 REV0222D72648

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 55154-8091-5

PEG3350

Polyethylene Glycol 3350

Powder for Oral Solution, Osmotic Laxative

5-Packets NET WT 0.5 OZ (17 g) EACH

100% bag label
100% bag label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130055154809153GTIN-13: 0055154809153
EAN-13: 0055154809153
GTIN-12: 055154809153
UPC-A: 055154809153
GTIN storage (14 digits): 00055154809153
d804d78d-bf7c-4ae2-a3a7-d1e7337bbeb8-00.jpg

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 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
55154-809155154-8091-5
0904-6931

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

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42025-10-23full-release2026-06-01 01:41:21
32024-02-06full-release2026-06-01 00:08:28

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 · 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 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A203928-001POLYETHYLENE 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…
2019-12-13 00:20 UTC2019-12A203928-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-2474a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203928-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-2474a2ff9319b5…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Polyethylene glycol 3350POLYETHYLENE GLYCOL 3350Cardinal Health 107, LLC4e8b6a32-11ec-4419-9ec8-aaa1823899722026-06-19WarningsExact identifier
ndc (package): 55154-8091-5
ndc (product): 55154-8091
ndc11 (package): 55154809105
spl id: 7f3bcd03-92c9-4221-a9f7-133ebfcb49e0
spl set id: 4e8b6a32-11ec-4419-9ec8-aaa182389972
Polyethylene glycol 3350POLYETHYLENE GLYCOL 3350Major Pharmaceuticalsddc9d2b1-87d8-44fa-bac6-0a7261f335642026-05-12WarningsExact identifier
ndc (product): 0904-6931

Reported adverse events (FAERS/openFDA)#

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