STOOL SOFTENER

Manufacturer
STRATEGIC SOURCING SERVICES LLC | GCP Laboratories
Effective date
2019-12-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:48:18

Label at a glance#

ProductSTOOL SOFTENER
Active ingredientDOCUSATE SODIUM
Label structure9 sections

Indications and uses

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

Dosage and administration

adults and children 12 years and older: take 1-2 tablets daily until first bowel movement; 1 tablet daily thereafter, or as directed by doctor children under 12: consult a doctor do not exceed recommended dose

Storage and handling

each tablet contains: calcium 50 mg, sodium 8 mg for institutional use only package not child resistant store at room temperature 15°C-30°C (59°F-86°F) Tamper Evident: Do not use if imprinted seal under cap is missing or broken

Label contents#

Full prescribing information#

Active ingredient

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

Ask a doctor before use if you

  • have stomach pain, nausea or vomiting
  • have a sudden change in bowel habits that persists over a period of 2 weeks
  • are presently taking mineral oil

Stop use and ask a doctor if

  • you need to use a laxative longer than 1 week
  • you have rectal bleeding or fail to have a bowel movement. These could be signs of a serious condition.

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

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years and older: take 1-2 tablets daily until first bowel movement; 1 tablet daily thereafter, or as directed by doctor
  • children under 12: consult a doctor
  • do not exceed recommended dose

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains: calcium 50 mg, sodium 8 mg
  • for institutional use only
  • package not child resistant
  • store at room temperature 15°C-30°C (59°F-86°F)
  • Tamper Evident: Do not use if imprinted seal under cap is missing or broken

Inactive ingredients

INACTIVE INGREDIENT SECTION

cellulose, croscarmellose sodium, dicalcium phosphate, magnesium stearate, silica, stearic acid, talc

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HEM 421HEM 421NDC 62011-0286-1

HealthMart PHARMACY

Stool
Softener
TABLETS

Docusate Sodium 100 mg

relieves occasional constipation

1000 Tablets

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62011-0286-1EA - Each62011-0286a437006f-2bab-4fe6-ab77-57019bf1bc1b12016-11-08

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62011-028662011-0286-1
75841-421

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML · Source PDF

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
ed873130-8231-1fc9-e053-2a95a90a64dc3ec58345-31a7-62a4-e054-00144ff8d46c2022-11-15WarningsExact identifier
spl set id: 3ec58345-31a7-62a4-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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