DOCUSATE SODIUM

Manufacturer
Spirit Pharmaceuticals LLC
Effective date
2024-12-13
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:43:16

Label at a glance#

ProductDOCUSATE SODIUM
Active ingredientDOCUSATE SODIUM
Label structure16 sections

Indications and uses

for the prevention of the dry, hard stools for relief of occassional constipation. This product generally produces a bowel movement within 12 to 72 hours

Dosage and administration

adult and children 12 years and over: take 1-3 gelcaps, preferably at bedtime children 2 to under 12 years of age: take 1 gelcap at bedtime children under 2 years of age: ask a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each gelcaps)

OTC - ACTIVE INGREDIENT SECTION

Docusate Sodium 100 mg 

Purpose

OTC - PURPOSE SECTION

Stool Softner

Uses

INDICATIONS & USAGE SECTION

  • for the prevention of the dry, hard stools
  • for relief of occassional constipation. This product generally produces a bowel movement within 12 to 72 hours

Do not use

WARNINGS SECTION

if you are currently taking mineral oil, unless directed to so 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 abd ask a doctor if you

OTC - STOP USE SECTION

have rectal bleeding fail to have a bowel movement occur after use.

If pregnant or breast-feeding 

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

Keep out of reach of children

In case of accidental overdose, get medical help or contact a Poison Control Center 1(800)222-1222 immediately.

Stop use and ask a doctor if you

OTC - STOP USE SECTION

have rectal bleeding fail to have bowel movement occur after use.

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 accidental overdose, get medical help or contact a Poison Control Center 1-800-222-1222 immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adult and children 12 years and over: take 1-3 gelcaps, preferably at bedtime
  • children 2 to under 12 years of age: take 1 gelcap at bedtime
  • children under 2 years of age: ask a doctor

Other information

OTHER SAFETY INFORMATION

  • Store at room temperature 15-30°C  (59-86°F) 
  • do not use if safety seal under cap is torn or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C Red #33, FD&C Red#40, FD&C Yellow#6, gelatin,

glycerin, polyethylene glycol 400, propylene glycol, purified

water, shellac, sorbitol solution, titanium dioxide.

Questions or comments?

OTC - QUESTIONS SECTION

1-888-333-9792

PRICNIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in

Colace ® Gel Caps *

STOOL

SOFTENER

DOCUSATE SODIUM 100 mg

Gentle

Effective

Stimulant-Free Relief

100 GELCAPS

Docusate 100 mg 100ctDocusate 100 mg 100ct

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68210-0350-1DOCUSATE SODIUM1 in 1 CARTONCAPSULE, LIQUID FILLED16
68210-0350-1DOCUSATE SODIUM100 in 1 BOTTLECAPSULE, LIQUID FILLED1006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-0350DOCUSATE SODIUM CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS LLC]6Legacy NDC, 2 package rows20241215_69ca6847-bb21-4b16-917e-caf7fe98a5f8.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68210-035068210-0350-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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
292d7a26-c25c-72df-e063-6394a90a519869ca6847-bb21-4b16-917e-caf7fe98a5f82024-12-13WarningsExact identifier
spl id: 292d7a26-c25c-72df-e063-6394a90a5198
spl set id: 69ca6847-bb21-4b16-917e-caf7fe98a5f8

Reported adverse events (FAERS/openFDA)#

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