Stool Softener Laxative

Manufacturer
TARGET CORPORATION | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED
Effective date
2025-06-25
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:03:52

Label at a glance#

ProductStool Softener Laxative
Active ingredientDOCUSATE SODIUM
Label structure15 sections

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each softgel)

Docusate sodium USP 100 mg

OTC - PURPOSE SECTION

Purpose

Stool softener

INDICATIONS & USAGE SECTION

Uses:

  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours

WARNINGS SECTION

Warnings

OTC - DO NOT USE SECTION

Do not use

  • 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 habits that lasts over 2 weeks

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • 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 (1-800-222-1222).

DOSAGE & ADMINISTRATION SECTION

Directions:

  • 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 1-3 softgels daily
children 2 to under 12 years of agetake 1 softgel daily

children under 2 years

ask a doctor

OTHER SAFETY INFORMATION

Other information

  • each capsule contains: sodium 6 mg
  • keep tightly closed.
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F).

INACTIVE INGREDIENT SECTION

Inactive ingredients D&C red no. 33, FD&C blue no. 1, FD&C red no. 40, FD&C yellow no. 6, ferrosoferric oxide, gelatin, glycerin, polyethylene glycol 400, propylene glycol, purified water, shellac, sorbitol solution, titanium dioxide

OTC - QUESTIONS SECTION

Questions or comments? Call 1-800-910-6874

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

730T_160s_LBL730T_160s_LBL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1115005docusate sodium 100 MG Oral CapsulePSN3
1115005docusate sodium 100 MG Oral CapsuleSCD3
1115005DOSS Sodium 100 MG Oral CapsuleSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11673-512-66Stool Softener Laxative160 in 1 BOTTLECAPSULE, LIQUID FILLED1603

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11673-51211673-512-66

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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
Stool Softener LaxativeDOCUSATE SODIUMTARGET CORPORATION28fce2e2-2101-df88-e063-6394a90aa3de2025-06-25WarningsExact identifier
ndc (package): 11673-512-66
ndc (product): 11673-512
ndc11 (package): 11673051266
spl id: 38643494-58ec-38e8-e063-6294a90a919f
spl set id: 28fce2e2-2101-df88-e063-6394a90aa3de

Reported adverse events (FAERS/openFDA)#

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