Stool Softener Regular Strength

Manufacturer: Spirit Pharmaceuticals LLC
Effective date: 2024-12-10
Label type: HUMAN OTC DRUG LABEL
Version: 6
Source: full-release
Hydrated at: 2026-06-01 00:41:56

Label at a glance#

ProductStool Softener Regular Strength

Active ingredientDOCUSATE SODIUM

Label structure15 sections

Indications and uses

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

Dosage and administration

take only by mouth. Doses may be taken as asingle daily dose or in divided doses. adults & children 12 years of age & over take 1–3 softgels daily children 2 to under 12 years of age take 1 softgel daily children under 2 years of age ask a doctor

Storage and handling

• 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

Label contents#

Full prescribing information#

Active Ingredient (in each tablet)

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 12–72 hours

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

• fever • mucus in the stool

Ask a doctor or pharmacist before use if you are if you have

OTC - ASK DOCTOR/PHARMACIST 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 asingle daily dose or in divided doses.

adults & children 12 years of age & over	take 1–3 softgels daily
children 2 to under 12 years of age	take 1 softgel daily
children under 2 years of age	ask a doctor

Other information

STORAGE AND HANDLING SECTION

• 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 #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol-400, povidone, propylene glycol, purified water, sorbitol solution

Questions or comments?

OTC - QUESTIONS SECTION

1-888-333-9792

Distributed by:

SPL UNCLASSIFIED SECTION

Cabinet Health P.B.C.

Pouch

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Stool Softener

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1115005	docusate sodium 100 MG Oral Capsule	PSN	6
1115005	docusate sodium 100 MG Oral Capsule	SCD	6
1115005	DOSS Sodium 100 MG Oral Capsule	SY	6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68210-4176-3	Stool Softener Regular Strength	30 in 1 POUCH	CAPSULE, LIQUID FILLED	30		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68210-4176	STOOL SOFTENER REGULAR STRENGTH (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS LLC]	6	Legacy NDC, 1 package rows	20241212_46be4007-399f-4e43-9330-ac36f2de96ef.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

Stool Softener Regular Strength
Docusate sodium
FD&C RED NO. 40
FD&C YELLOW NO. 6
GELATIN
GLYCERIN
POLYETHYLENE GLYCOL 400
POVIDONE
PROPYLENE GLYCOL
WATER
SORBITOL SOLUTION
TITANIUM DIOXIDE
DOCUSATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
68210-4176	68210-4176-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
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
POVIDONE	FZ989GH94E	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT
SORBITOL SOLUTION	8KW3E207O2	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
28f06503-2795-a3ce-e063-6394a90a93d2			46be4007-399f-4e43-9330-ac36f2de96ef	2024-12-10	Warnings	Exact identifier spl id: 28f06503-2795-a3ce-e063-6394a90a93d2 spl set id: 46be4007-399f-4e43-9330-ac36f2de96ef

Reported adverse events (FAERS/openFDA)#

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