FDA.reportPublic FDA data

Stool Softener

Manufacturer
Geri-Care Pharmaceutical Corp
Effective date
2025-12-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:19:39

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

do not exceed recommended dose adults and children 12 years and older: take 1-3 softgels daily, usually 1 softgel daily after the first bowel movement, or as directed by a doctor. children under 12: ask a doctor

Storage and handling

• each softgel contains: sodium 5 mg. Very low sodium • store at 59°-77°F (15°-25°C) • keep tightly closed • Tamper Evident: Do not use if imprinted seal under cap is missing or broken.

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Docusate Sodium 100 mg

Purpose

OTC - PURPOSE SECTION

Stool Softener

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

• noticed a sudden change in bowel habits that lasts for over a period of 2 weeks

• are presently taking mineral oil

Stop use and ask a doctor if

• you have rectal bleeding or fail to have a bowel movement.

These could be signs of a serious condition.

• you need to use a laxative for longer than 1 week

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

  • do not exceed recommended dose
  • adults and children 12 years and older: take 1-3 softgels daily, usually 1 softgel daily after the first bowel movement, or as directed by a doctor.
  • children under 12: ask a doctor

Other information

STORAGE AND HANDLING SECTION

• each softgel contains: sodium 5 mg. Very low sodium
• store at 59°-77°F (15°-25°C)
• keep tightly closed
• Tamper Evident: Do not use if imprinted seal
under cap is missing or broken.

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, PEG, propylene glycol, purified water, sorbitol sorbitan
solution, white edible ink.

Questions or comments?

OTC - QUESTIONS SECTION

1-800-540-3765

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1115005docusate sodium 100 MG Oral CapsulePSN2
1115005docusate sodium 100 MG Oral CapsuleSCD2
1115005DOSS Sodium 100 MG Oral CapsuleSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57896-411-01Stool Softener100 in 1 BOTTLECAPSULE, LIQUID FILLED1002
57896-411-10Stool Softener1000 in 1 BOTTLECAPSULE, LIQUID FILLED10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-411-10EA - Each57896-4119a67a8a1-8e65-4c24-9240-3b7b253e773712024-03-12

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
57896-41157896-411-10, 57896-411-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C RED NO. 40WZB9127XOAIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
DOCUSATE SODIUMF05Q2T2JA0ACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SORBITAN6O92ICV9RUIACT

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 SoftenerDOCUSATE SODIUMGeri-Care Pharmaceutical Corp1057c0bf-4bf6-ea17-e063-6294a90a59842025-12-04WarningsExact identifier
ndc (package): 57896-411-01
ndc (package): 57896-411-10
ndc (product): 57896-411
ndc11 (package): 57896041110
ndc11 (package): 57896041101
spl id: 4525c13b-a7de-e67a-e063-6394a90a4224
spl set id: 1057c0bf-4bf6-ea17-e063-6294a90a5984

Reported adverse events (FAERS/openFDA)#

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