FDA.reportPublic FDA data

MiraLAX

Manufacturer
Cardinal Health 107, LLC
Effective date
2025-11-07
Label type
HUMAN OTC DRUG LABEL
Version
17
Source
full-release
Hydrated at
2026-06-01 01:43:25

Label at a glance#

ProductMiraLAX
Active ingredientPOLYETHYLENE GLYCOL 3350
Label structure14 sections

Dosage and administration

• 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 (white section in cap) • adults and children 17 years of age and older: o use once a day o fill to top of white section in cap which is marked to indicate the correct dose (17 g) o stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or r...

Storage and handling

• 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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each dose) (Bottle Only)

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Osmotic Laxative

Active ingredient (in each dose) (Packet Only)

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

SPL UNCLASSIFIED SECTION

Do not use if you are allergic to polyethylene glycol

OTC - DO NOT USE SECTION

Do not use 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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor of pharmacist before use if you are taking a prescription drug

OTC - WHEN USING SECTION

When using this product you may have loose, watery, more frequent stools

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you have rectal bleeding or you nausea, bloating or 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions (Bottle Only)

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 (white section in cap)
  • adults and children 17 years of age and older:
    • use once a day
    • fill to top of white 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
    • 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 no more than 7 days
  • children 16 years of age or under: ask a doctor

Directions (Packet Only)

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 seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken

Inactive ingredients

INACTIVE INGREDIENT SECTION

none

Questions or comments?

OTC - QUESTIONS SECTION

1-800-MiraLAX (1-800-647-2529)

.

SPL UNCLASSIFIED SECTION

Overbagged with 6 x 17g packets per bag, NDC 55154-5035-6

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

L4532222-11025 / L4532222-21025

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 55154-5035-6

MiraLAX®

Polyethylene Glycol 3350,

Powder for Solution, Osmotic Laxative

6 PACKETS NET WT 0.5OZ (17g)

bag label
bag label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
876195MiraLAX 17 GM Powder for Oral SolutionPSN17
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSN17
876195polyethylene glycol 3350 17000 MG Powder for Oral Solution [Miralax]SBD17
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCD17
876195Miralax 17 GM Powder for Oral SolutionSY17
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSY17

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
POLYETHYLENE GLYCOL 3350 Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130055154503563GTIN-13: 0055154503563
EAN-13: 0055154503563
GTIN-12: 055154503563
UPC-A: 055154503563
GTIN storage (14 digits): 00055154503563		3ac22f1f-b34c-0c18-e063-6394a90a9742-00.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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-5035-6MiraLAX6 in 1 BAGPOWDER, FOR SOLUTION617
55154-5035-6MiraLAX17 g in 1 PACKETPOWDER, FOR SOLUTION1717

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11523-7268-3EA - Each11523-7268933e3d13-3afb-4f83-a441-303e0e1f21ab12012-07-24
11523-7268-4GM - Gram11523-7268450ecaa3-e208-4d65-96a1-a40b2428691612016-04-04
11523-7268-8EA - Each11523-7268ba0fa4db-d34f-46d4-8e2d-f2141ba5d5bc12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
POLYETHYLENE GLYCOL 3350ACTIVE INGREDIENTG2M7P15E5P4
POLYETHYLENE GLYCOL 3350ACTIVE MOIETYG2M7P15E5P4

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55154-503555154-5035-6
11523-7268

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
162025-02-28full-release2026-06-01 00:56:31

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
N022015-001MIRALAXPOLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORALRLD, RS2006-10-06
N022015-002MIRALAXPOLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORALRLD, RS2006-10-06

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 2 · 48 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N022015-001MIRALAX17GM/SCOOPFULFOR SOLUTION / ORALRLD, RS2006-10-0684e616aacf4f…
2026-09-14 22:38:342026-08N022015-002MIRALAX17GM/PACKETFOR SOLUTION / ORALRLD, RS2006-10-0684e616aacf4f…
2026-08-18 06:07:402026-07N022015-001MIRALAX17GM/SCOOPFULFOR SOLUTION / ORALRLD, RS2006-10-06caaa826d4ba7…
2026-08-18 06:07:402026-07N022015-002MIRALAX17GM/PACKETFOR SOLUTION / ORALRLD, RS2006-10-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022015-001MIRALAX17GM/SCOOPFULFOR SOLUTION / ORALRLD, RS2006-10-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022015-002MIRALAX17GM/PACKETFOR SOLUTION / ORALRLD, RS2006-10-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022015-001MIRALAX17GM/SCOOPFULFOR SOLUTION / ORALRLD, RS2006-10-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022015-002MIRALAX17GM/PACKETFOR SOLUTION / ORALRLD, RS2006-10-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08N022015-001MIRALAX17GM/SCOOPFULFOR SOLUTION / ORALRLD, RS2006-10-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022015-001MIRALAX17GM/SCOOPFULFOR SOLUTION / ORALRLD, RS2006-10-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022015-001MIRALAX17GM/SCOOPFULFOR SOLUTION / ORALRLD, RS2006-10-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022015-001MIRALAX17GM/SCOOPFULFOR SOLUTION / ORALRLD, RS2006-10-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022015-001MIRALAX17GM/SCOOPFULFOR SOLUTION / ORALRLD, RS2006-10-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022015-001MIRALAX17GM/SCOOPFULFOR SOLUTION / ORALRLD, RS2006-10-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022015-001MIRALAX17GM/SCOOPFULFOR SOLUTION / ORALRLD, RS2006-10-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022015-001MIRALAX17GM/SCOOPFULFOR SOLUTION / ORALRLD, RS2006-10-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022015-001MIRALAX17GM/SCOOPFULFOR SOLUTION / ORALRLD, RS2006-10-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022015-001MIRALAX17GM/SCOOPFULFOR SOLUTION / ORALRLD, RS2006-10-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022015-001MIRALAX17GM/SCOOPFULFOR SOLUTION / ORALRLD, RS2006-10-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022015-001MIRALAX17GM/SCOOPFULFOR SOLUTION / ORALRLD, RS2006-10-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022015-001MIRALAX17GM/SCOOPFULFOR SOLUTION / ORALRLD, RS2006-10-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022015-001MIRALAX17GM/SCOOPFULFOR SOLUTION / ORALRLD, RS2006-10-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022015-001MIRALAX17GM/SCOOPFULFOR SOLUTION / ORALRLD, RS2006-10-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022015-001MIRALAX17GM/SCOOPFULFOR SOLUTION / ORALRLD, RS2006-10-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022015-001MIRALAX17GM/SCOOPFULFOR SOLUTION / ORALRLD, RS2006-10-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022015-001MIRALAX17GM/SCOOPFULFOR SOLUTION / ORALRLD, RS2006-10-06782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022015-001MIRALAX17GM/SCOOPFULFOR SOLUTION / ORALRLD, RS2006-10-0687673890dc5c…
2021-03-12 10:30 UTC2021-03N022015-001MIRALAX17GM/SCOOPFULFOR SOLUTION / ORALRLD, RS2006-10-065aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022015-001MIRALAX17GM/SCOOPFULFOR SOLUTION / ORALRLD, RS2006-10-068869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022015-001MIRALAX17GM/SCOOPFULFOR SOLUTION / ORALRLD, RS2006-10-06c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022015-001MIRALAX17GM/SCOOPFULFOR SOLUTION / ORALRLD, RS2006-10-063f01610625f2…
2019-09-15 20:21 UTC2019-09N022015-001MIRALAX17GM/SCOOPFULFOR SOLUTION / ORALRLD, RS2006-10-06b00525d2431f…
2019-07-19 19:46 UTC2019-07N022015-001MIRALAX17GM/SCOOPFULFOR SOLUTION / ORALRLD, RS2006-10-06ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022015-001MIRALAX17GM/SCOOPFULFOR SOLUTION / ORALRLD, RS2006-10-066a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022015-001MIRALAX17GM/SCOOPFULFOR SOLUTION / ORALRLD, RS2006-10-061c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022015-001MIRALAX17GM/SCOOPFULFOR SOLUTION / ORALRLD, RS2006-10-06ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022015-001MIRALAX17GM/SCOOPFULFOR SOLUTION / ORALRLD, RS2006-10-06a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022015-001MIRALAX17GM/SCOOPFULFOR SOLUTION / ORALRLD, RS2006-10-069b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022015-001MIRALAX17GM/SCOOPFULFOR SOLUTION / ORALRLD, RS2006-10-06a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022015-001MIRALAX17GM/SCOOPFULFOR SOLUTION / ORALRLD, RS2006-10-063f0d92c62455…

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
MiraLAXPOLYETHYLENE GLYCOL 3350Bayer HealthCare LLC.d69ce3d4-7ca4-4fe3-b49e-6655e48d69632026-05-04WarningsExact identifier
ndc (product): 11523-7268
MiraLAXPOLYETHYLENE GLYCOL 3350Cardinal Health 107, LLC1771d3bf-954d-49ea-b260-3d356e5dcfa52025-11-07WarningsExact identifier
ndc (package): 55154-5035-6
ndc (product): 55154-5035
ndc11 (package): 55154503506
spl id: a30d3776-09c8-41aa-9282-ba2486632e07
spl set id: 1771d3bf-954d-49ea-b260-3d356e5dcfa5

Reported adverse events (FAERS/openFDA)#

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