FDA.reportPublic FDA data

Docusate Sodium

Manufacturer
PD-Rx Pharmaceuticals, Inc.
Effective date
2025-08-19
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:11:09

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)

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 overtake 1 to 3 softgels daily.
children 2 to under 12 years of agetake 1 softgel daily
children under 2 yearsask 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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Docusate sodium 100 mg is a orange oval softgel with imprint P51.

NDC 72789-274-30 Bottles of 30 softgels

Compare to the active ingredient in Colace ®Regular Strength Stool Softener†

Docusate sodium 100 mg

Stool Softener Laxative

Softgels

†This product is not manufactured or distributed by Avrio Health L.P., distributor of Colace® Regular Strength Stool Softener.

TAMPER EVIDENT: DO NOT USE IF SEAL IS BROKEN OR MISSING FROM BOTTLE.

Distributed by:

Docusate Sodium 100 mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Docusate Sodium 100 mgDocusate Sodium 100 mg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-274-30EA - Each72789-274d51b0bac-1758-4ce4-b79d-8a5f8548687112023-02-06
0904-6998-60EA - Each0904-6998d821c784-9742-4476-8dfb-c2f1c92a60eb12021-03-02

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
72789-27472789-274-30
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
NameUNIIKind
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN2G86QN327LIACT
SORBITAN6O92ICV9RUIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
GLYCERINPDC6A3C0OXIACT
DOCUSATE SODIUMF05Q2T2JA0ACTIB

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
3cba8930-c831-4d66-e063-6394a90a0c1e6591a3ec-e125-4b45-9000-36f8f22216382025-08-19WarningsExact identifier
spl id: 3cba8930-c831-4d66-e063-6394a90a0c1e
spl set id: 6591a3ec-e125-4b45-9000-36f8f2221638

Reported adverse events (FAERS/openFDA)#

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