DRUG FACTS

Manufacturer
CVS Pharmacy
Effective date
2026-07-22
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
daily-update
Hydrated at
2026-07-25 05:10:27

Label at a glance#

ProductStool Softener
Active ingredientDOCUSATE SODIUM
Label structure10 sections

Indications and uses

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

Dosage and administration

take with a glass of water adults and children 12 over and over take 1-3 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 5 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 relief of occasional constipation and irregularity
  • this product 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 directed by a doctor.

Ask a doctor before use if

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 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 over and overtake 1-3 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 5 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 sorbitan, sorbitol

Questions or comments?

OTC - QUESTIONS SECTION

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Dulcolax® Stool Softener*

Stool Softener

DOCUSATE SODIUM, 100 mg

Stool Softener Laxative

Gentle, softening relief

SOFTGELS

*This product is not manufactured or distributed by Chattem, Inc., distributor of Dulcolax® Stool Softener.

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

Distributed by: CVS Pharmacy, Inc. 

One CVS Drive, Woonsocket, RI 02895

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS HEALTH Stool Softener
CVS HEALTH Stool Softener

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130050428331460GTIN-13: 0050428331460
EAN-13: 0050428331460
GTIN-12: 050428331460
UPC-A: 050428331460
GTIN storage (14 digits): 00050428331460
docusate-sodium-100-mg-single-tone-softgels-pat-de-1.jpg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69842-862-25EA - Each69842-8622637b6b5-46cc-4396-94ac-d749099aef7f12021-11-09

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
69842-86269842-862-25, 69842-862-10

Ingredients#

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

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

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42024-03-07full-release2026-06-01 00:09:32

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
a8f985e5-5a59-49d3-80fb-e49468dc250089d2e4cf-b6f6-4c96-97bb-2e4b3dc852c72026-07-22WarningsExact identifier
spl id: a8f985e5-5a59-49d3-80fb-e49468dc2500
spl set id: 89d2e4cf-b6f6-4c96-97bb-2e4b3dc852c7

Reported adverse events (FAERS/openFDA)#

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