Label at a glance#

ProductDocusate Sodium

Active ingredientDOCUSATE SODIUM

Label structure9 sections

Indications and uses

prevents/relieves dry hard stool results usually occurs 1 to 3 days after the first dose

Dosage and administration

do not exceed recommended dose adults and children over 12 years take 1-2 softgels daily until first bowel movement; 1 softgel daily thereafter children 6 to 12 years take 1 softgel daily children under 6 years consult a doctor

Contacts and useful links#

PhoneLabel contact(866) 562-2756

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Docusate sodium 100 mg

Purpose

OTC - PURPOSE SECTION

Stool softener

Uses

INDICATIONS & USAGE SECTION

prevents/relieves dry hard stool
results usually occurs 1 to 3 days after the first dose

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

when abdominal pain, nausea, or vomiting are present
for more than one week unless directed by a doctor

Ask a doctor before use if you

OTC - ASK DOCTOR SECTION

are taking mineral oil
have 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 no bowel movement after 3 daysyou have rectal bleedingThese could be signs of a serious condition

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.

Directions

DOSAGE & ADMINISTRATION SECTION

do not exceed recommended dose

adults and children over 12 years	take 1-2 softgels daily until first bowel movement; 1 softgel daily thereafter
children 6 to 12 years	take 1 softgel daily
children under 6 years	consult a doctor

Other information

SPL UNCLASSIFIED SECTION

Tamper Evident: Do not use if safety seal under cap is broken or missing
store at room temperature 15^oto 30^oC (59^o to 86^oF)
protect from moisture

Questions?

OTC - QUESTIONS SECTION

Adverse drug event call: (866) 562-2756

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-0357

NDC: 50090-0357-0 20 CAPSULE in a BOTTLE

NDC: 50090-0357-2 60 CAPSULE in a BOTTLE

NDC: 50090-0357-4 30 CAPSULE in a BOTTLE

NDC: 50090-0357-1 100 CAPSULE in a BOTTLE

Docusate Sodium

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Data code	Code 128	238500099876541299		lbl500900357.jpg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16103-384-08	EA - Each	16103-384	361dab52-2147-4914-b73b-9688ea82cfdf	1	2012-07-24
16103-384-11	EA - Each	16103-384	8aad6e39-09d9-41ec-8bdf-69a2b8016118	1	2012-07-24

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

Docusate Sodium
DOCUSATE
D&C Yellow No. 10
FD&C Red No. 40
GELATIN, UNSPECIFIED
Glycerin
POLYETHYLENE GLYCOL, UNSPECIFIED
Propylene Glycol
Sorbitol

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
50090-0357	50090-0357-0, 50090-0357-2, 50090-0357-4, 50090-0357-1
16103-384

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DOCUSATE SODIUM	F05Q2T2JA0	ACTIB
D&C Yellow No. 10	35SW5USQ3G	IACT
FD&C Red No. 40	WZB9127XOA	IACT
GELATIN, UNSPECIFIED	2G86QN327L	IACT
Glycerin	PDC6A3C0OX	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
Propylene Glycol	6DC9Q167V3	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
df16dee8-7e8a-4236-8daf-bcf96f6ac0da			27a492e7-4e3e-4bc8-9851-ffa23cd903f6	2017-09-27	Warnings	Exact identifier spl id: df16dee8-7e8a-4236-8daf-bcf96f6ac0da spl set id: 27a492e7-4e3e-4bc8-9851-ffa23cd903f6

Reported adverse events (FAERS/openFDA)#

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