FDA.reportPublic FDA data

Stool Softener

Manufacturer
Good Sense (Geiss, Destin & Dunn, Inc.)
Effective date
2021-10-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:32:14

Label at a glance#

ProductStool Softener
Active ingredientDOCUSATE SODIUM
Label structure10 sections

Indications and uses

for temporary relief of occasional constipation and irregularity this product generally produces a bowel movement within 12 to 72 hours

Dosage and administration

take with a glass of water adults and children 12 over take 1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses. children 2 to under 12 years of age take 1 softgel daily children under 2 years ask a doctor

Storage and handling

each softgel contains: sodium 6 mg store 25ºC (77ºF); excursion permitted between 15-30ºC (59-86ºF)

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Docusate Sodium 100 mg

Purpose

OTC - PURPOSE SECTION

Stool softener laxative

Uses

INDICATIONS & USAGE SECTION

  • for temporary relief of occasional constipation and irregularity
  • this product generally produces a bowel movement within 12 to 72 hours

Warnings

WARNINGS SECTION

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

  • stomach pain
  • nausea
  • vomiting
  • a sudden change in bowel habits that lasts more than 2 weeks

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

presently taking mineral oil

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you have rectal bleeding or no bowel movement after using a laxative. These could be a sign of a serious condition 
  • you need to use a laxative for more than 1 week

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health care 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

  • take with a glass of water
adults and children 12 overtake 1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses.
children 2 to under 12 years of agetake 1 softgel daily
children under 2 years ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each softgel contains: sodium 6 mg
  • store 25ºC (77ºF); excursion permitted between 15-30ºC (59-86ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol*, purified water and sorbitan, sorbitol

*contains one or more of these ingredients

Questions or comments?

OTC - QUESTIONS SECTION

 Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Gentle Stool Softener

Docusate Sodium

Stool Softener Laxative

For Gentle, Softening Relief

Stimulant-Free

†Compare to active ingredient in DulcoEase® Stool Softener

†This product is not manufactured or distributed by Boehringer Ingelheim Pharmaceuticals, distributor of DulcoEase®.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by: Geiss, Destin & Dunn, Inc.

Peachtree City, GA 30269

www.valuelabels.com

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GOOD SENSE Gentle Stool Softener
GOOD SENSE Gentle Stool Softener

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50804-58450804-584-25

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
DOCUSATE SODIUMF05Q2T2JA0ACTIB
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN2G86QN327LIACT
SORBITAN6O92ICV9RUIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
GLYCERINPDC6A3C0OXIACT

Source Document#

Source XML · Source PDF

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
2b11970a-ccca-46e7-806e-6563d8996852649b122f-7d12-459b-a281-d712010d18282021-10-15WarningsExact identifier
spl id: 2b11970a-ccca-46e7-806e-6563d8996852
spl set id: 649b122f-7d12-459b-a281-d712010d1828

Reported adverse events (FAERS/openFDA)#

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