STOOL SOFTENER

Manufacturer
DIRECT RX
Effective date
2021-04-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:45:44

Label at a glance#

ProductSTOOL SOFTENER
Active ingredientDOCUSATE SODIUM
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Docusate Sodium 100 mg

OTC - PURPOSE SECTION

Stool Softener Laxative

OTC - WHEN USING SECTION

relieves occasional constipation (irregularity)

generally produces bowel movement in 12 to 72 hours

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. In case of overdose, get medical help or contact a Poison Control Center right away.

OTC - WHEN USING SECTION

• adults and children 12 years and older: take 1-2 softgel daily until first bowel movement; 1 softgel daily thereafter, or as directed by doctor

• children under 12: consult a doctor

• do not exceed recommended dose

OTHER SAFETY INFORMATION

• each softgel contains: sodium 5 mg. very low sodium

• store at 15°C-25°C(59° F-77° F)

• keep tightly closed

• product from USA or Canada

• Tamper Evident: Do not use if imprinted seal under cap is missing or broken.

INACTIVE INGREDIENT SECTION

FD&C red #40, gelatin, glycerin, edible ink, PEG, propylene glycol, sorbitol special, water. Also contains D&C yellow #10
or FD&C yellow #6 (sunset yellow).

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

195195

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-195-71EA - Each72189-1950179da90-062c-49dc-aa22-f44a6992081112021-05-05
57896-408-01EA - Each57896-408a3a8f09f-f9bf-4aa2-ba09-5156be87c52f12019-03-12
57896-408-03EA - Each57896-408832d75ba-545f-4446-9985-7d6e39383f7f12019-04-11
57896-408-10EA - Each57896-408cbc35fd5-94e6-4160-821c-a22ccc3e4a2b12020-08-06
57896-408-20EA - Each57896-4085a868761-8bd5-4dff-bd9a-705a6a79935012019-04-11

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72189-19572189-195-71
57896-408

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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
074a1fcf-ad00-9e02-e063-6394a90ad9e3bec3450e-73fe-d223-e053-2a95a90afc002023-10-09WarningsExact identifier
spl set id: bec3450e-73fe-d223-e053-2a95a90afc00

Reported adverse events (FAERS/openFDA)#

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