FDA.reportPublic FDA data

rugby PEG 3350

Manufacturer
Rugby Laboratories
Effective date
2024-07-26
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:16:25

Key Label Information#

Active Ingredients And Purpose

Active ingredient (in each dose)

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

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 • 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 more than 7 days • children 16 years of age or under: ask a doctor

Other Label Information

Inactive ingredients

none

Questions or comments?

1-800-719-9260

Principal Display Panel

Rugby ® Compare to the active ingredient in MiraLAX ® PEG 3350 Polyethylene Glycol 3350 Powder for Solution Osmotic Laxative Relieves Occasional Constipation (Irregularity) Softens Stool Unflavored Grit Free Powder NET WT 4.1 OZ (119 g) 7 Once-Daily Doses

Label Images#

306-8t-polyethylene-glycol
306-8t-polyethylene-glycol

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSN6
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCD6
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSY6

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
0536-1052-24rugby PEG 3350238 g in 1 BOTTLEPOWDER, FOR SOLUTION2386
0536-1052-27rugby PEG 3350510 g in 1 BOTTLEPOWDER, FOR SOLUTION5106
0536-1052-60rugby PEG 3350119 g in 1 BOTTLEPOWDER, FOR SOLUTION1196
0536-1052-84rugby PEG 3350850 g in 1 BOTTLEPOWDER, FOR SOLUTION8506

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1052RUGBY PEG 3350 (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [RUGBY LABORATORIES]6Current NDC, Legacy NDC, 4 package rows20240802_9c76c9b3-5203-400b-8f3a-3690bea30924.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1052-24GM - Gram0536-1052834db3b3-10f5-4d3d-a6cd-a40979f8c99512015-05-05
0536-1052-27GM - Gram0536-1052799bfc75-09a8-4b77-a130-3135914d237012015-03-03
0536-1052-60GM - Gram0536-1052922e24a6-c0a8-46ca-8623-6c574551a34f12024-11-05
0536-1052-84GM - Gram0536-1052749404ac-2510-436a-b6a3-8298e6665be912015-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
POLYETHYLENE GLYCOL 3350ACTIVE INGREDIENTG2M7P15E5P1
POLYETHYLENE GLYCOL 3350ACTIVE MOIETYG2M7P15E5P1

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0536-10520536-1052-24, 0536-1052-27, 0536-1052-84, 0536-1052-60

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 (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

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 (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 more than 7 days • children 16 years of age or under: ask a doctor

Other information

OTHER SAFETY INFORMATION

• 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

1-800-719-9260

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rugby ® Compare to the active ingredient in MiraLAX ® PEG 3350 Polyethylene Glycol 3350 Powder for Solution Osmotic Laxative Relieves Occasional Constipation (Irregularity) Softens Stool Unflavored Grit Free Powder NET WT 4.1 OZ (119 g) 7 Once-Daily Doses

Source Document#

Source XML · Source PDF