FOS 421

Manufacturer
STRATEGIC SOURCING SERVICES LLC | Geri-Care Pharmaceuticals, Corp | GCP Laboratories
Effective date
2026-07-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-07-18 05:11:11

Label at a glance#

ProductStool Softener
Active ingredientDOCUSATE SODIUM
Label structure10 sections

Indications and uses

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

Dosage and administration

adults and children 12 years and older: take 1-3 tablets daily, or as directed by a doctor. May be taken as a single daily dose or in divided doses. children under 12: ask a doctor do not exceed recommended dose

Storage and handling

each tablet contains: calcium 50 mg, sodium 10 mg store at room temperature 15°C-30°C (59°F-86°F) see end flap for expiration date and lot number

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Docusate Sodium 100 mg

Purpose

OTC - PURPOSE SECTION

Stool Softener

Uses

INDICATIONS & USAGE SECTION

  • relieves occasional constipation (irregularity)
  • this product 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 (800) 222-1222.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years and older: take 1-3 tablets daily, or as directed by a doctor. May be taken as a single daily dose or in divided doses.
  • children under 12: ask a doctor
  • do not exceed recommended dose

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains: calcium 50 mg, sodium 10 mg
  • store at room temperature 15°C-30°C (59°F-86°F)
  • see end flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Call 833-358-6431 Monday to Friday 9:00am to 7:00pm EST

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1071-1EA - Each70677-107135dcc76d-4473-4b05-86ec-d1d7e65b5b6212023-10-16

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
70677-107170677-1071-1

Ingredients#

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

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

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22023-10-23full-release2026-05-31 23:57:31

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 SoftenerDOCUSATE SODIUMSTRATEGIC SOURCING SERVICES LLCff2179bd-cc76-9ee9-e053-6294a90a01c92026-07-15WarningsExact identifier
ndc (package): 70677-1071-1
ndc (product): 70677-1071
ndc11 (package): 70677107101
spl id: 56aa2f75-d30a-000d-e063-6394a90afcf7
spl set id: ff2179bd-cc76-9ee9-e053-6294a90a01c9

Reported adverse events (FAERS/openFDA)#

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