FDA.reportPublic FDA data

STOOL SOFTNER

Manufacturer
SDA Laboratories, Inc. | Pharbest Pharmaceuticals, Inc. | Pharbest Pharmaceuticals, Inc
Effective date
2016-03-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:45:14

Label at a glance#

ProductSTOOL SOFTNER
Active ingredientDOCUSATE SODIUM
Label structure9 sections

Indications and uses

relieves occasional constipation (irregularity) generally produces bowel movement in 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

Tamper Evident: do not use if safety seal under cap is broken or missing each capsule contains: sodium 6 mg VERY LOW SODIUM store at 25°C (77°F); excursions permitted between 15 o -30 o C (59 o -86 o F). Keep tightly closed. This Package for Households Without Young Children 

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Docusate sodium 100 mg

Purpose

OTC - PURPOSE SECTION

Stool softener

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION


Do not use

OTC - DO NOT USE SECTION

if you are presently taking mineral oil, unless told to do 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 stool softener laxative for more than 1 week

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health 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 (1-800-222-1222).

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 over                        take 1-3 softgels daily
children 2 to under 12 years of agetake 1 softgel daily
children under 2 yearsask a doctor

Other information

STORAGE AND HANDLING SECTION

  • Tamper Evident: do not use if safety seal under cap is broken or missing
  • each capsule contains: sodium 6 mg
  • VERY LOW SODIUM
  • store at 25°C (77°F); excursions permitted between 15o-30oC (59o-86oF).

Keep tightly closed.

This Package for Households Without Young Children 

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C Red #33,Edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special, titanium dioxide 

Questions?

OTC - QUESTIONS SECTION

Adverse drug event call: (800) 687-0176 Mon- Fri 8 AM to 4 PM

* This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Colace®.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 66424-399-10

*Compare to the active ingredient in Colace®

STOOL SOFTENER

ORIGINAL

DOCUSATE SODIUM 100mg

SDA LABORATORIES

1000 Softgel Capsules

SDA Docusate Sodium 100 mg Capsule 1000 CT LabelSDA Docusate Sodium 100 mg Capsule 1000 CT Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1115005docusate sodium 100 MG Oral CapsulePSN1
1115005docusate sodium 100 MG Oral CapsuleSCD1
1115005DOSS Sodium 100 MG Oral CapsuleSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66424-399-012020-01-31C16284748780-19d75b9d0-076c-f424-e053-dadaa90a57ceDrug Facts
66424-399-102020-01-31C16284748780-19d75b9d0-076c-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66424-399-01STOOL SOFTNER100 in 1 BOTTLECAPSULE, LIQUID FILLED1001
66424-399-10STOOL SOFTNER1000 in 1 BOTTLECAPSULE, LIQUID FILLED10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66424-399STOOL SOFTNER (DOCUSATE SODIUM ) CAPSULE, LIQUID FILLED [SDA LABORATORIES, INC.]1Legacy NDC, 2 package rows20160302_c7b1c950-f863-4f90-8413-6725c3005094.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66424-399-01EA - Each66424-399f1c0f5ec-a9ad-4875-83ce-23a6c9fe620612017-03-06
66424-399-10EA - Each66424-39960208ae9-93b5-45a0-99d0-d87eb336378512017-03-06

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66424-39966424-399-01, 66424-399-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
DOCUSATE SODIUMF05Q2T2JA0ACTIB
D&C RED NO. 339DBA0SBB0LIACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOLS3WJQ0SDW1AIACT
SORBITOL506T60A25RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

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
dc14824e-7da5-4ca9-8627-37257ea0b002c7b1c950-f863-4f90-8413-6725c30050942016-03-01WarningsExact identifier
spl id: dc14824e-7da5-4ca9-8627-37257ea0b002
spl set id: c7b1c950-f863-4f90-8413-6725c3005094

Reported adverse events (FAERS/openFDA)#

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