FDA.reportPublic FDA data

Good Sense Clear Lax

Manufacturer
L. Perrigo Company
Effective date
2023-01-24
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-05-31 23:54:48

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

Other 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

none

Questions or comments?

1-800-719-9260

Principal Display Panel

GoodSense ® Unflavored Powder Grit Free ClearLax ® Polyethylene Glycol 3350 Powder for Solution, Osmotic Laxative ● Relieves Occasional Constipation/Irregularity ● Softens Stool Compare to active ingredient of MiraLAX ® NET WT 26.9 OZ (765 g) 45 Once-Daily Doses

Label Images#

image-01
image-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
880407ClearLax 17 GM Powder for Oral SolutionPSN10
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSN10
880407polyethylene glycol 3350 17000 MG Powder for Oral Solution [ClearLax]SBD10
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCD10
880407ClearLax 17 GM Powder for Oral SolutionSY10
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSY10

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
0113-0306-01Good Sense Clear Lax119 g in 1 BOTTLEPOWDER, FOR SOLUTION11910
0113-0306-02Good Sense Clear Lax238 g in 1 BOTTLEPOWDER, FOR SOLUTION23810
0113-0306-03Good Sense Clear Lax510 g in 1 BOTTLEPOWDER, FOR SOLUTION51010
0113-0306-09Good Sense Clear Lax765 g in 1 BOTTLEPOWDER, FOR SOLUTION76510
0113-0306-17Good Sense Clear Lax289 g in 1 BOTTLEPOWDER, FOR SOLUTION28910
0113-0306-18Good Sense Clear Lax153 g in 1 BOTTLEPOWDER, FOR SOLUTION15310
0113-0306-19Good Sense Clear Lax595 g in 1 BOTTLEPOWDER, FOR SOLUTION59510

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-0306GOOD SENSE CLEAR LAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [L. PERRIGO COMPANY]10Current NDC, Legacy NDC, 7 package rows20230429_435db89c-1e32-4da5-b7d0-15e407162715.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-0306-01GM - Gram0113-0306ce121c50-d58c-4534-81ab-42dab967ca1912012-07-24
0113-0306-02GM - Gram0113-030639f9d542-8248-4f3c-aeb1-921dca2e57ba12012-07-24
0113-0306-03GM - Gram0113-0306ab1c9984-a38c-487b-be98-730cd619a5d012012-07-24
0113-0306-17GM - Gram0113-03063013694b-c3d0-4635-a25e-b27bb7757f5d12019-04-11
0113-0306-19GM - Gram0113-03064cb8a239-6455-498a-9b70-901e2cc5a1a912019-04-11
0113-0306-52EA - Each0113-0306b2e6a93a-5e60-44a7-b1ff-f6c206acc8a512012-07-24

DailyMed Socrata Ingredients#

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

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0113-03060113-0306-02, 0113-0306-03, 0113-0306-01, 0113-0306-17, 0113-0306-19, 0113-0306-18, 0113-0306-09

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

STORAGE AND HANDLING 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

1-800-719-9260

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GoodSense ® Unflavored Powder Grit Free ClearLax ® Polyethylene Glycol 3350 Powder for Solution, Osmotic Laxative ● Relieves Occasional Constipation/Irregularity ● Softens Stool Compare to active ingredient of MiraLAX ® NET WT 26.9 OZ (765 g) 45 Once-Daily Doses

Source Document#

Source XML