FDA.reportPublic FDA data

DOCUSATE SODIUM 250 mg Two-Tone, Capsule, liquid filled

Manufacturer
TOPCO ASSOCIATES LLC | Reese Pharmaceutical
Effective date
2024-12-18
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:45:09

Label at a glance#

ProductTopcare Stool Softener laxative
Active ingredientDOCUSATE SODIUM
Label structure9 sections

Indications and uses

relieves occasional constipation (irregularity) generally produces a 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 VERY LOW SODIUM store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Docusate Sodium 250 mg

Purpose

OTC - PURPOSE SECTION

Stool softener

Uses

INDICATIONS & USAGE SECTION

  • relieves occasional constipation (irregularity)
  • generally produces a 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                                

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel movements that lasts 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 signs of a serious condition.
  • you need to use a stool softener laxative for more than 1 week

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center 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 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

Other information

STORAGE AND HANDLING SECTION

  • each softgel contains: sodium 5 mg
  • VERY LOW SODIUM
  • store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat

Inactive Ingredients

INACTIVE INGREDIENT SECTION

D&C Red No. 33, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerol, Polyethylene glycol, purified water, sorbitol, titanium dioxide

Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007
©TOPCO RSEA0621 QUESTIONS? 1-888-423-0139 topcare@topco.com www.topcarebrand.com

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1245468docusate sodium 250 MG Oral CapsulePSN4
1245468docusate sodium 250 MG Oral CapsuleSCD4
1245468DOSS Sodium 250 MG Oral CapsuleSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76162-764-10Topcare Stool Softenerlaxative100 in 1 BOTTLECAPSULE, LIQUID FILLED1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76162-764TOPCARE STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [TOPCO ASSOCIATES LLC]4Current NDC, Legacy NDC, 1 package rows20241220_f9302fc2-684d-4cc2-bdd7-7ad0e9304edb.zip

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
76162-76476162-764-10

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
DOCUSATE SODIUMF05Q2T2JA0ACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT

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
Topcare Stool Softener laxativeDOCUSATE SODIUMTOPCO ASSOCIATES LLCf9302fc2-684d-4cc2-bdd7-7ad0e9304edb2024-12-18WarningsExact identifier
ndc (package): 76162-764-10
ndc (product): 76162-764
ndc11 (package): 76162076410
spl id: 6f717723-3634-45dc-bc27-c9c15c0f432a
spl set id: f9302fc2-684d-4cc2-bdd7-7ad0e9304edb

Reported adverse events (FAERS/openFDA)#

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