Label at a glance#

ProductCVS Health Stool Softener

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 6 softgels daily children 2 to under 12 years of age take 1 to 3 softgels daily children under 2 years ask a doctor

Storage and handling

■ each softgel contains: sodium 3 mg VERY LOW SODIUM ■ store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F). Keep tightly closed.

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-888-333-9792

PhoneLabel contact1-800-SHOP CVS

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient(in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Docusate sodium 50 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 AND PRECAUTIONS 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 6 softgels daily
children 2 to under 12 years of age	take 1 to 3 softgels daily
children under 2 years	ask a doctor

Other information

STORAGE AND HANDLING SECTION

■ each softgel contains: sodium 3 mg VERY LOW
SODIUM
■ store at 25°C (77°F); excursions permitted between
15°-30°C (59°-86°F). Keep tightly closed.

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C Red No. 40, gelatin, glycerin, polyethylene
glycol-400, povidone, propylene glycol, purified water,
sorbitol solution, titanium dioxide

OTC - QUESTIONS SECTION

Questions or comments? 1-888-333-9792

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS Health

Compare to the
active ingredient
in Colace

Stool
Softener
DOCUSATE SODIUM, 50 mg
• Stimulant free
• Gentle & effective
• Comfortable relief
of constipation

Actual Bottle Size
on Side Pane

100 SOFTGELS

RETAIN CARTON FOR COMPLETE PRODUCT INFORMATION

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

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

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2019 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
Made in India V-33609

image description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1247759	docusate sodium 50 MG Oral Capsule	PSN	7
1247759	docusate sodium 50 MG Oral Capsule	SCD	7
1247759	DOSS Sodium 50 MG Oral Capsule	SY	7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69842-523-01	CVS Health Stool Softener	1 in 1 CARTON	CAPSULE	1		7
69842-523-01	CVS Health Stool Softener	100 in 1 BOTTLE	CAPSULE	100		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69842-523	CVS HEALTH STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE [CVS PHARMACY]	7	Legacy NDC, 2 package rows	20250101_76449dc3-1249-4793-bfa7-e60771df89f0.zip

Products#

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

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

CVS Health Stool Softener
Docusate sodium
FD&C RED NO. 40
GELATIN
GLYCERIN
POLYETHYLENE GLYCOL 400
PROPYLENE GLYCOL
POVIDONE K30
WATER
SORBITOL
TITANIUM DIOXIDE
DOCUSATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69842-523	69842-523-01

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
Name	UNII	Kind
FD&C RED NO. 40	WZB9127XOA	IACT
GELATIN	2G86QN327L	IACT
GLYCERIN	PDC6A3C0OX	IACT
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
POVIDONE K30	U725QWY32X	IACT
WATER	059QF0KO0R	IACT
SORBITOL	506T60A25R	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
DOCUSATE SODIUM	F05Q2T2JA0	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
297e2aba-c04e-725f-e063-6394a90a29f6			76449dc3-1249-4793-bfa7-e60771df89f0	2024-12-17	Warnings	Exact identifier spl id: 297e2aba-c04e-725f-e063-6394a90a29f6 spl set id: 76449dc3-1249-4793-bfa7-e60771df89f0

Reported adverse events (FAERS/openFDA)#

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