DOCUSATE SODIUM

Manufacturer
Direct_Rx
Effective date
2020-01-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:45:10

Label at a glance#

ProductDOCUSATE SODIUM
Active ingredientDOCUSATE SODIUM
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Docusate Sodium 100 mg

Purpose

Stool softener

INDICATIONS & USAGE SECTION

for prevention of dry, hard stools
for relief of occasional constipation

This product generally produces a bowel movement within 12 to 72 hours.

WARNINGS SECTION

Do not use

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

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

Stop use and ask a doctor if

you have rectal bleeding
you fail to have a bowel movement after use

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health care professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

adults and children over 12 years of age take 1 to 3 softgels preferably at bedtime
children 6-12 years of age take 1 softgel at bedtime
children under 6 years ask a doctor

OTHER SAFETY INFORMATION

each softgel contains: sodium 6 mg
store between 15º-30ºC (59º-86ºF)

INACTIVE INGREDIENT SECTION


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

OTC - QUESTIONS SECTION


1-800-645-2158

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

459-60459-60

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-459-602023-10-24C16284748780-1d6a99b39-ba67-a426-e053-dadaa90af4c2DOCUSATE SODIUM
61919-459-602022-01-28C16284748780-1d6a99b39-ba67-a426-e053-dadaa90af4c2DOCUSATE SODIUM

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-459-30EA - Each61919-4596661372f-c5b8-4668-b3f7-4c1311433bf512016-04-04
61919-459-71EA - Each61919-459e2138f19-4d5a-49f4-af53-feb66ebe8d4b12015-10-02
0536-3756-01EA - Each0536-37568fd965ad-aad1-4339-b7a2-362c0a1f306112012-07-24
0536-3756-10EA - Each0536-37563791905f-77b1-4557-9988-9c77fa97f97612012-07-24

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61919-45961919-459-60
0536-3756

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

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
0749d384-6099-f2f6-e063-6394a90a8dac901a3592-b7e3-8adb-e053-2a95a90a5a802023-10-09WarningsExact identifier
spl set id: 901a3592-b7e3-8adb-e053-2a95a90a5a80

Reported adverse events (FAERS/openFDA)#

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