STOOL SOFTENER

Manufacturer: PuraCap Pharmaceutical LLC | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.
Effective date: 2021-05-06
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 23:40:14

Label at a glance#

ProductSTOOL SOFTENER

Active ingredientDOCUSATE SODIUM

Label structure10 sections

Indications and uses

for the prevention of dry, hard stools for relief of occasional constipation this product generally produces a bowel movement within 12 to 72 hours

Dosage and administration

adults and children 12 years of age and over: take 1 softgel daily or as directed by a doctor children under 12 years of age: ask a doctor

Storage and handling

each softgel contains: sodium 15 mg store at 20º-25ºC (68º-77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

Contacts and useful links#

PhoneLabel contact1-855-215-8180

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Docusate sodium 250 mg

Purpose

OTC - PURPOSE SECTION

Stool softener laxative

Uses

INDICATIONS & USAGE SECTION

for the prevention of dry, hard stools
for relief of occasional constipation
this product generally produces a bowel movement within 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 you have

OTC - ASK DOCTOR SECTION

stomach pain
nausea
vomiting
noticed a sudden change in bowel habits that last 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 laxative for more than 1 week

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, 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.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years of age and over: take 1 softgel daily or as directed by a doctor
children under 12 years of age: ask a doctor

Other information

STORAGE AND HANDLING SECTION

each softgel contains:sodium 15 mg
store at 20º-25ºC (68º-77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan solution, and white edible ink

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free: 1-855-215-8180

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

STOOL SOFTENER

DOCUSATE SODIUM 250mg 100 SOFTGELS

Compare to the active ingredient in COLACE®

NDC 51013-814-24

Container label 250 mg 100ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1245468	docusate sodium 250 MG Oral Capsule	PSN	1
1245468	docusate sodium 250 MG Oral Capsule	SCD	1
1245468	DOSS Sodium 250 MG Oral Capsule	SY	1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51013-814-24	2025-01-30	C162847	48780-1	2cef2736-6990-d83d-e063-dadaa90ab31f	STOOL SOFTENER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51013-814-24	STOOL SOFTENER	100 in 1 BOTTLE	CAPSULE, LIQUID FILLED	100		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51013-814	STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PURACAP PHARMACEUTICAL LLC]	1	Legacy NDC, 1 package rows	20210508_f8393da2-637f-4fee-8bb7-0a5f3e66d13a.zip

Products#

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

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

STOOL SOFTENER
DOCUSATE SODIUM
DOCUSATE
ANHYDROUS CITRIC ACID
FD&C RED NO. 40
FD&C YELLOW NO. 6
GELATIN
GLYCERIN
POLYETHYLENE GLYCOL, UNSPECIFIED
PROPYLENE GLYCOL
WATER
SORBITOL
SORBITAN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
51013-814	51013-814-24

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
DOCUSATE SODIUM	F05Q2T2JA0	ACTIB
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
GELATIN	2G86QN327L	IACT
GLYCERIN	PDC6A3C0OX	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT
SORBITOL	506T60A25R	IACT
SORBITAN	6O92ICV9RU	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
58eeb318-031b-4872-985d-cd7e0f379716			f8393da2-637f-4fee-8bb7-0a5f3e66d13a	2021-05-06	Warnings	Exact identifier spl id: 58eeb318-031b-4872-985d-cd7e0f379716 spl set id: f8393da2-637f-4fee-8bb7-0a5f3e66d13a

Reported adverse events (FAERS/openFDA)#

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