STOOL SOFTENER

Manufacturer: PuraCap Pharmaceutical LLC | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.
Effective date: 2019-12-11
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 23:01:58

Label at a glance#

ProductSTOOL SOFTENER

Active ingredientDOCUSATE SODIUM

Label structure10 sections

Indications and uses

for temporary 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 years and over 1 to 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 1 softgel daily children under 2 years of age ask a doctor

Storage and handling

each softgel contains: sodium 5 mg store at room temperature 15°-30°C (59°-86°F) protect from excessive humidity

Contacts and useful links#

PhoneLabel contact1-800-833-6278

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

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

Warnings

WARNINGS SECTION

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

stomach pain, nausea or vomiting
a sudden change in bowel habits that lasts more than 2 weeks

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are presently taking mineral oil

Stop use and ask a doctor if

OTC - STOP USE SECTION

you have rectal bleeding or no bowel movement after using this product. 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

take with a glass of water

adults and children 12 years and over	1 to 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	1 softgel daily
children under 2 years of age	ask a doctor

Other information

STORAGE AND HANDLING SECTION

each softgel contains: sodium 5 mg
store at room temperature 15°-30°C (59°-86°F)
protect from excessive humidity

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free: 1-800-833-6278

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

STOOL SOFTENER

DOCUSATE SODIUM 100mg 100 SOFTGELS

Compare to the active ingredient in DULCOLAX®

NDC 51013-120-24

DDM Dss 100mg Red 100ct-carton

DDM Dss 100mg Red 100ct-bottle

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1115005	docusate sodium 100 MG Oral Capsule	PSN	2
1115005	docusate sodium 100 MG Oral Capsule	SCD	2
1115005	DOSS Sodium 100 MG Oral Capsule	SY	2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51013-120-24	2025-01-30	C162847	48780-1	2cef2736-a3be-d83d-e063-dadaa90ab31f	STOOL SOFTENER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51013-120-24	STOOL SOFTENER	100 in 1 BOTTLE	CAPSULE, LIQUID FILLED	100		2
51013-120-24	STOOL SOFTENER	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51013-120	STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PURACAP PHARMACEUTICAL LLC]	2	Legacy NDC, 2 package rows	20191212_3442ffb7-659c-46a9-8164-ab0d5fb52f14.zip

Products#

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

DailyMed product names page 1 of 1 · 12 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

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
51013-120	51013-120-24

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
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

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
99b712f8-e65c-4d2d-92f2-be989dfb4179			3442ffb7-659c-46a9-8164-ab0d5fb52f14	2019-12-11	Warnings	Exact identifier spl id: 99b712f8-e65c-4d2d-92f2-be989dfb4179 spl set id: 3442ffb7-659c-46a9-8164-ab0d5fb52f14

Reported adverse events (FAERS/openFDA)#

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