Label at a glance#

ProductStool Softener

Active ingredientDOCUSATE SODIUM

Label structure10 sections

Dosage and administration

Take only by mouth. Adults and children 12 years and over: take 1-3 softgels, daily. Doses may be taken as a single daily dose or in divided doses. Children 2 to under 12 years of age: take 1 softgel daily Children under 2 years: ask a doctor

Storage and handling

store at 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.

Adults and children 12 years and over: take 1-3 softgels, daily. Doses may be taken as a single daily dose or in divided doses.

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 softgel contains: sodium 5mg
VERY LOW SODIUM
do not use if imprinted safety seal under cap is broken or missing.

Storage

STORAGE AND HANDLING SECTION

store at 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 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 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69168-420-01	Stool Softener	100 in 1 BOTTLE	CAPSULE	100	8
69168-420-30	Stool Softener	30 in 1 BOTTLE	CAPSULE	30	8
69168-420-81	Stool Softener	400 in 1 BOTTLE	CAPSULE	400	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69168-420	STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE [ALLEGIANT HEALTH]	8	Current NDC, Legacy NDC, 3 package rows	20231116_30c9ff75-cee4-4632-86fd-acfdf5ee85af.zip

Products#

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

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

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
69168-420	69168-420-01, 69168-420-81, 69168-420-30

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
Stool Softener	DOCUSATE SODIUM	Allegiant Health	30c9ff75-cee4-4632-86fd-acfdf5ee85af	2020-10-27	Warnings	Exact identifier ndc (package): 69168-420-30 ndc (package): 69168-420-81 ndc (package): 69168-420-01 ndc (product): 69168-420 ndc11 (package): 69168042001 ndc11 (package): 69168042081 ndc11 (package): 69168042030 spl id: 6eb62390-6dc1-4038-a518-5a8b94cc51dc spl set id: 30c9ff75-cee4-4632-86fd-acfdf5ee85af

Reported adverse events (FAERS/openFDA)#

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