CVS Health Stool Softener Clear

Manufacturer
CVS Pharmacy
Effective date
2024-12-17
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:44:38

Label at a glance#

ProductCVS Health Stool Softener Clear
Active ingredientDOCUSATE SODIUM
Label structure14 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 to 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 5 mg  ■ store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F).  ■ Keep tightly closed

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

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
■ if you are presently taking mineral oil, unless told to do
so by a doctor

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor before use if you have
■ stomach pain ■ nausea ■ vomiting
■ noticed a sudden change in bowel habits that lasts over
2 weeks

OTC - DO NOT USE SECTION

Stop use and ask a doctor if
■ 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional
before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 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 to 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 5 mg 

■ store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F). 

■ Keep tightly closed

Inactive ingredients

INACTIVE INGREDIENT SECTION

gelatin, glycerin, polyethylene glycol-400, povidone (PVP K-30), propylene glycol, purified water, sorbitol solution, titanium dioxide

OTC - QUESTIONS SECTION

Questions or comments? 1-888-333-9792

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS Health

Compare to the
active ingredient
in Colace®*

Stool
Softener
DOCUSATE SODIUM, 100 mg
•Relieves constipation

  • Stimulant free
  • Gentle & effective

DYE
FREE

60 SOFTGELS

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

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1115005docusate sodium 100 MG Oral CapsulePSN6
1115005docusate sodium 100 MG Oral CapsuleSCD6
1115005DOSS Sodium 100 MG Oral CapsuleSY6

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69842-633-602026-01-29C16284748780-149896155-acfd-586f-e063-e6dba90add90CVS Health Stool Softener Clear

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-633-60CVS Health Stool Softener Clear60 in 1 BOTTLECAPSULE606
69842-633-60CVS Health Stool Softener Clear1 in 1 CARTONCAPSULE16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-633CVS HEALTH STOOL SOFTENER CLEAR (DOCUSATE SODIUM) CAPSULE [CVS PHARMACY]6Legacy NDC, 2 package rows20241220_4d77facc-a01b-4b6d-8770-b0a429ec5bfd.zip

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
69842-63369842-633-60

Ingredients#

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

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

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
297e4324-cd2d-6676-e063-6294a90a31fa4d77facc-a01b-4b6d-8770-b0a429ec5bfd2024-12-17WarningsExact identifier
spl id: 297e4324-cd2d-6676-e063-6294a90a31fa
spl set id: 4d77facc-a01b-4b6d-8770-b0a429ec5bfd

Reported adverse events (FAERS/openFDA)#

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