Topcare Stool Softener

Manufacturer: TopCo Associates, LLC
Effective date: 2021-02-19
Label type: HUMAN OTC DRUG LABEL
Version: 8
Source: full-release
Hydrated at: 2026-05-31 23:56:51

Label at a glance#

ProductTopcare Stool Softener

Active ingredientDOCUSATE SODIUM

Label structure10 sections

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

store 25°C (77°F) excursions permitted between 15°– 30°C (59°–86°F)

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-888-952-0050

Label contents#

Full prescribing information#

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Docusate sodium 100mg

Purpose

OTC - PURPOSE SECTION

Stool softener

Use(s)

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

OTC - ASK DOCTOR SECTION

you have

stomach pain
nausea
vomiting
noticed a sudden change in bowel habits that lasts over a period of 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

Pregnancy/Breastfeeding

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 accidental overdose, get medical help or contact a Poison Control Center
(1-800-222-1222) 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 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

Other information

SPL UNCLASSIFIED SECTION

each capsule contains: sodium 5mg
VERY LOW SODIUM

Storage

STORAGE AND HANDLING SECTION

store 25°C (77°F) excursions permitted between 15°– 30°C (59°–86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Black edible ink, citric acid, D&C red #33, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special

Questions

OTC - QUESTIONS SECTION

Call 1-888-952-0050 Monday through Friday 9am-5pm

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Stool SoftenerStool Softener

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1115005	docusate sodium 100 MG Oral Capsule	PSN	8
1115005	docusate sodium 100 MG Oral Capsule	SCD	8
1115005	DOSS Sodium 100 MG Oral Capsule	SY	8

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
76162-006-01	Topcare Stool Softener	100 in 1 BOTTLE	CAPSULE, LIQUID FILLED	100	8
76162-006-60	Topcare Stool Softener	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1	8
76162-006-60	Topcare Stool Softener	60 in 1 BOTTLE	CAPSULE, LIQUID FILLED	60	8
76162-006-81	Topcare Stool Softener	400 in 1 BOTTLE	CAPSULE, LIQUID FILLED	400	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76162-006	TOPCARE STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [TOPCO ASSOCIATES, LLC]	8	Current NDC, Legacy NDC, 4 package rows	20231018_6f4fddda-4129-4087-b0e4-ababc5558484.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

Topcare Stool Softener
Docusate Sodium
DOCUSATE
ANHYDROUS CITRIC ACID
D&C RED NO. 33
FD&C BLUE NO. 1
FD&C RED NO. 40
FD&C YELLOW NO. 6
GELATIN
GLYCERIN
POLYETHYLENE GLYCOL 400
PROPYLENE GLYCOL
SORBITOL SOLUTION
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
76162-006	76162-006-60, 76162-006-01, 76162-006-81

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DOCUSATE SODIUM	F05Q2T2JA0	ACTIB
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
D&C RED NO. 33	9DBA0SBB0L	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
GELATIN	2G86QN327L	IACT
GLYCERIN	PDC6A3C0OX	IACT
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SORBITOL SOLUTION	8KW3E207O2	IACT
WATER	059QF0KO0R	IACT

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
Topcare Stool Softener	DOCUSATE SODIUM	TopCo Associates, LLC	6f4fddda-4129-4087-b0e4-ababc5558484	2021-02-19	Warnings	Exact identifier ndc (package): 76162-006-81 ndc (package): 76162-006-01 ndc (package): 76162-006-60 ndc (product): 76162-006 ndc11 (package): 76162000681 ndc11 (package): 76162000601 ndc11 (package): 76162000660 spl id: 8d7c4d0b-d04c-4423-ba3a-dd93c58b2a9b spl set id: 6f4fddda-4129-4087-b0e4-ababc5558484

Reported adverse events (FAERS/openFDA)#

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