FDA.reportPublic FDA data

Stool Softener

Manufacturer
P & L Development, LLC
Effective date
2023-04-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:32:53

Label at a glance#

ProductStool Softener
Active ingredientDOCUSATE SODIUM
Label structure10 sections

Indications and uses

relieves occasional constipation (irregularity) generally produces a bowel movement within 12 to 72 hours

Dosage and administration

take only by mouth. Doses may be taken as a single daily dose or in divided doses.  Adults and children 12 years and over take 1-3 softgels daily  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 at 25 o  C (77 o  F); excursions permitted between 15-30 o C (59- 86 o F)

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

  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement within 12 to 72 hours

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

if you are presently taking mineral oil, unless told so by a doctor.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts over 2 weeks

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs 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 only by mouth. Doses may be taken as a single daily dose or in divided doses.
 Adults and children 12 years and overtake 1-3 softgels daily 
children 2 to under 12 years of age take 1 softgel daily 
children under 2 years ask a doctor 

Other information

STORAGE AND HANDLING SECTION

  • each softgel contains: sodium 6 mg
  • store at 25o C (77o F); excursions permitted between 15-30o C (59- 86o F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

D&C Red #33*,  edible ink, FD&C blue #1*, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol*, purified water, sorbitan, sorbitol, titanium dioxide

*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

stool softener

docusate sodium 100 mg

stool softener laxative

softgels

†Compare to the active ingredient in Colace® Regular Strength Stool Softener

†This product is not manufactured or distributed by Purdue Product L.P., distributor of Colace® Regular Strength Stool Softener.

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

Distributed by: PL Developments

200 Hicks Street, Westbury, NY 11590

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

WELLNESS BASICS Stool Softener
WELLNESS BASICS Stool Softener

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59726-078-012023-04-18C16284748780-1d6a99b39-9f4f-a426-e053-dadaa90af4c2Drug Facts
59726-078-102023-04-18C16284748780-1d6a99b39-9f4f-a426-e053-dadaa90af4c2Drug Facts
59726-078-402023-04-18C16284748780-1d6a99b39-9f4f-a426-e053-dadaa90af4c2Drug Facts
59726-078-012022-01-28C16284748780-1d6a99b39-9f4f-a426-e053-dadaa90af4c2Drug Facts
59726-078-102022-01-28C16284748780-1d6a99b39-9f4f-a426-e053-dadaa90af4c2Drug Facts
59726-078-402022-01-28C16284748780-1d6a99b39-9f4f-a426-e053-dadaa90af4c2Drug Facts

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59726-07859726-078-10, 59726-078-40, 59726-078-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
DOCUSATE SODIUMF05Q2T2JA0ACTIB
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITAN6O92ICV9RUIACT
SORBITOL506T60A25RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
D&C RED NO. 339DBA0SBB0LIACT

Source Document#

Source XML

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
b407b247-79c4-486b-9062-8b41de4c2ba8b0dbf87f-d824-438f-94bf-5aef4eb9c3172023-04-18WarningsExact identifier
spl id: b407b247-79c4-486b-9062-8b41de4c2ba8
spl set id: b0dbf87f-d824-438f-94bf-5aef4eb9c317

Reported adverse events (FAERS/openFDA)#

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