FDA.reportPublic FDA data

Docusate Sodium

Manufacturer
Marc Glassman, Inc.
Effective date
2016-12-28
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:49:45

Label at a glance#

ProductDocusate Sodium
Active ingredientDOCUSATE SODIUM
Label structure8 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 and over: take 1 to 3 capsules, preferably at bedtime ■ Children 2 to under 12 years of age: take 1 capsule at bedtime ■ Children under 2 years of age: ask a doctor

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Docusate sodium 100mg

Purpose

OTC - PURPOSE SECTION

Stool softener

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 currently taking mineral oil, unless directed by a doctor  

■ when abdominal pain, nausea, or vomiting are present 

■  for longer than 1 week unless directed by a doctor

Ask a doctor before use if you

OTC - ASK DOCTOR SECTION

notice a sudden change in bowel habits that persists over a period of 2 weeks

Stop use and ask a doctor if you

OTC - STOP USE SECTION

■ have rectal bleeding

■ fail to have a bowel movement occur after use

Pregnancy/Breastfeeding

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

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

■ Adults and children 12 years and over: take 1 to 3 capsules, preferably at bedtime

■ Children 2 to under 12 years of age: take 1 capsule at bedtime

■ Children under 2 years of age: ask a doctor

Other information

SPL UNCLASSIFIED SECTION

each capsule contains: sodium 5mg

store at room temperature 15°-30°C (59°-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, gelatin, glycerin, polyethylene glycol 400, purified water, sorbitol

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

 Docusate SodiumDocusate Sodium

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68998-31468998-314-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
DOCUSATE SODIUMF05Q2T2JA0ACTIB
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN2G86QN327LIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
SORBITOL506T60A25RIACT

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a7657585-f04d-41be-9e7c-91044068fa7b526db2dd-ad57-4dc7-ac44-1c5c9ee4536e2016-12-28WarningsExact identifier
spl id: a7657585-f04d-41be-9e7c-91044068fa7b
spl set id: 526db2dd-ad57-4dc7-ac44-1c5c9ee4536e

Reported adverse events (FAERS/openFDA)#

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