GlycoLax

Manufacturer
Lannett Company, Inc.
Effective date
2012-06-08
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 23:43:43

Label at a glance#

ProductGlycoLax Osmotic Laxative
Active ingredientPOLYETHYLENE GLYCOL 3350
Label structure9 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 adults and children 17 years of age and older: fill to 17 grams line in cap for the correct dose stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink use once daily use no more than 7 days children 16 years of ...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Polyethylene Glycol 3350, 17 grams (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

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/PHARMACIST 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 or 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 your nausea, bloating, 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 reach of children. 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
  • the bottle top is a measuring cap marked to contain 17 grams of powder when filled to the indicated line
  • adults and children 17 years of age and older:
    • fill to 17 grams line in cap for the correct dose
    • stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
    • use once daily
    • use no more than 7 days
  • children 16 years of age or under: ask a doctor

Other information

SPL UNCLASSIFIED SECTION

  • store at 20° - 25°C (68° - 77°F)
  • tamper-evident: do not use if printed foil seal under cap is missing, open or broken

Inactive ingredients

INACTIVE INGREDIENT SECTION

none

Questions or comments?

OTC - QUESTIONS SECTION

1-866-822-0068

Rev.3E

Principal Display Panel - 510 g Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 62175-190-30

Compare to the active ingredient in MiraLAX®*

GlycoLax®

Polythylene Glycol 3350, Powder for Solution, Osmotic Laxative

Original
Prescription
Strength

  • Softens Stool
  • Relieves Occasional Constipation (Irregularity)

CONTAINS 30 ONCE-DAILY DOSES

NET WT 17.9 OZ (510 g)

Distributed by: Kremers Urban Pharmaceuticals Inc., Princeton, NJ 08540, USA

*GlycoLax® is not manufactured or distributed by Schering-Plough
HealthCare Products, Inc., distributor of MiraLAX®.
Lot.:        Exp.:
CIA76417A     Rev. 3E

Principal Display Panel - 510 g Bottle Label
Principal Display Panel - 510 g Bottle Label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62175-190-07GM - Gram62175-190556de3f6-7f65-44aa-84e8-edf3ff7dfc8512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Polyethylene Glycol 3350ACTIVE INGREDIENTG2M7P15E5P2
Polyethylene Glycol 3350ACTIVE MOIETYG2M7P15E5P2

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
62175-19062175-190-07, 62175-190-14, 62175-190-30

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 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
A090600-001GLYCOLAXPOLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-06
A090600-002GLYCOLAXPOLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06

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 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A090600-001GLYCOLAX17GM/PACKETFOR SOLUTION / ORAL2009-10-0684e616aacf4f…
2026-09-14 22:38:342026-08A090600-002GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2009-10-0684e616aacf4f…
2026-08-18 06:07:402026-07A090600-001GLYCOLAX17GM/PACKETFOR SOLUTION / ORAL2009-10-06caaa826d4ba7…
2026-08-18 06:07:402026-07A090600-002GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090600-001GLYCOLAX17GM/PACKETFOR SOLUTION / ORAL2009-10-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090600-002GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090600-001GLYCOLAX17GM/PACKETFOR SOLUTION / ORAL2009-10-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090600-002GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2009-10-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A090600-001GLYCOLAX17GM/PACKETFOR SOLUTION / ORAL2009-10-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090600-002GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2009-10-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090600-001GLYCOLAX17GM/PACKETFOR SOLUTION / ORAL2009-10-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090600-002GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090600-001GLYCOLAX17GM/PACKETFOR SOLUTION / ORAL2009-10-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090600-002GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090600-001GLYCOLAX17GM/PACKETFOR SOLUTION / ORAL2009-10-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090600-002GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2009-10-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090600-001GLYCOLAX17GM/PACKETFOR SOLUTION / ORAL2009-10-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090600-002GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2009-10-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090600-001GLYCOLAX17GM/PACKETFOR SOLUTION / ORAL2009-10-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090600-002GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2009-10-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090600-001GLYCOLAX17GM/PACKETFOR SOLUTION / ORAL2009-10-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090600-002GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090600-001GLYCOLAX17GM/PACKETFOR SOLUTION / ORAL2009-10-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A090600-002GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090600-001GLYCOLAX17GM/PACKETFOR SOLUTION / ORAL2009-10-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090600-002GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2009-10-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090600-001GLYCOLAX17GM/PACKETFOR SOLUTION / ORAL2009-10-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090600-002GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090600-001GLYCOLAX17GM/PACKETFOR SOLUTION / ORAL2009-10-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090600-002GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2009-10-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090600-001GLYCOLAX17GM/PACKETFOR SOLUTION / ORAL2009-10-068072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090600-002GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2009-10-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090600-001GLYCOLAX17GM/PACKETFOR SOLUTION / ORAL2009-10-065c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090600-002GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2009-10-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090600-001GLYCOLAX17GM/PACKETFOR SOLUTION / ORAL2009-10-065d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090600-002GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2009-10-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090600-001GLYCOLAX17GM/PACKETFOR SOLUTION / ORAL2009-10-064b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090600-002GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2009-10-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090600-001GLYCOLAX17GM/PACKETFOR SOLUTION / ORAL2009-10-0674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090600-002GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2009-10-0674a2ff9319b5…

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
bb2ea983-3af4-47f3-b0ff-efa5588f9d925e25cd00-69a8-4d83-b3a4-d97fffeaf8932012-06-08WarningsExact identifier
spl set id: 5e25cd00-69a8-4d83-b3a4-d97fffeaf893

Reported adverse events (FAERS/openFDA)#

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