Docusate Sodium

Manufacturer: A-S Medication Solutions
Effective date: 2023-11-01
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 23:58:37

Label at a glance#

ProductDocusate Sodium

Active ingredientDOCUSATE SODIUM

Label structure10 sections

Indications and uses

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

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 to 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

each softgel contains: sodium 5 mg store at 25ºC (77ºF);excursions permitted between 15-30ºC (59-86ºF)

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-616-2471

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Docusate Sodium 100 mg

Purpose

OTC - PURPOSE SECTION

Stool softener laxative

Uses

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 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 a signs of a serious condition.
you need to use a 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 (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 to 3 softgels daily.
children 2 to under 12 years of age	take 1 softgel daily
children under 2 years	ask a doctor

Other information

STORAGE AND HANDLING SECTION

each softgel contains: sodium 5 mg
store at 25ºC (77ºF);excursions permitted between 15-30ºC (59-86ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water sorbitan, sorbitol

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-616-2471

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-6140

NDC: 50090-6140-1 100 CAPSULE in a BOTTLE, PLASTIC

DOCUSATE SODIUM

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1115005	docusate sodium 100 MG Oral Capsule	PSN	3
1115005	docusate sodium 100 MG Oral Capsule	SCD	3
1115005	DOSS Sodium 100 MG Oral Capsule	SY	3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-6140-1	Docusate Sodium	100 in 1 BOTTLE, PLASTIC	CAPSULE	100		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-6140	DOCUSATE SODIUM CAPSULE [A-S MEDICATION SOLUTIONS]	3	Current NDC, Legacy NDC, 1 package rows	20231102_5999904a-6ac8-4d9e-951c-6e64e8cd93eb.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-6140-1	EA - Each	50090-6140	2b00f3a2-dc2b-4df1-bb5e-627149d880b4	1	2022-11-07
0904-6998-60	EA - Each	0904-6998	d821c784-9742-4476-8dfb-c2f1c92a60eb	1	2021-03-02

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

Docusate Sodium
DOCUSATE
FD&C RED NO. 40
FD&C YELLOW NO. 6
GELATIN, UNSPECIFIED
SORBITAN
POLYETHYLENE GLYCOL, UNSPECIFIED
PROPYLENE GLYCOL
WATER
SORBITOL
GLYCERIN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
50090-6140	50090-6140-1
0904-6998

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
FD&C RED NO. 40	WZB9127XOA	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
GELATIN, UNSPECIFIED	2G86QN327L	IACT
SORBITAN	6O92ICV9RU	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT
SORBITOL	506T60A25R	IACT
GLYCERIN	PDC6A3C0OX	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
Docusate Sodium	DOCUSATE SODIUM	A-S Medication Solutions	5999904a-6ac8-4d9e-951c-6e64e8cd93eb	2023-11-01	Warnings	Exact identifier ndc (package): 50090-6140-1 ndc (product): 50090-6140 ndc11 (package): 50090614001 spl id: 958c57a2-7fec-478f-9028-677a213ba0cd spl set id: 5999904a-6ac8-4d9e-951c-6e64e8cd93eb

Reported adverse events (FAERS/openFDA)#

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