FDA.reportPublic FDA data

Stool Softener with Laxative

Manufacturer
Geri-Care Pharmaceutical Corp
Effective date
2023-12-06
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:03:29

Label at a glance#

ProductStool Softener with Laxative
Active ingredientSENNOSIDES, DOCUSATE SODIUM
Label structure8 sections

Indications and uses

relieves occasional constipation (irregularity) this product generally produces bowel movement in 6 to 12 hours

Dosage and administration

Take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses adults and children 12 years and over take 2-4 tablets daily children under 12 years of age ask a doctor

Storage and handling

each tablet contains: calcium 20 mg, sodium 3 mg store at controlled room temperature Tamper Evident: Do not use if imprinted seal under cap is missing or broken. product of India

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Docusate Sodium 50 mg
Sennosides 8.6 mg

Purpose

OTC - PURPOSE SECTION

Stool softener

Stimulant laxative

Uses

INDICATIONS & USAGE SECTION

  • relieves occasional constipation (irregularity)
  • this product generally produces bowel movement in 6 to 12 hours

Warnings

WARNINGS SECTION

Do not use

  • laxative products for longer than 1 week unless directed by a doctor
  • if you are presently taking mineral oil, unless directed by a doctor

Ask a doctor before use if you have

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts over 2 weeks

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.

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

  • Take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses
adults and children 12 years and overtake 2-4 tablets daily
children under 12 years of ageask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains: calcium 20 mg, sodium 3 mg
  • store at controlled room temperature
  • Tamper Evident: Do not use if imprinted seal under cap is missing or broken.
  • product of India

Inactive ingredients

INACTIVE INGREDIENT SECTION

cellulose, croscarmellose sodium, dicalcium phosphate, FD&C blue #2 lake, FD&C red #40 lake, hypromellose, magnesium stearate, PEG, silica, talc, titanium dioxide.

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSN4
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCD4
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57896-304-01Stool Softener with Laxative100 in 1 BOTTLETABLET, FILM COATED1004
57896-304-10Stool Softener with Laxative1000 in 1 BOTTLETABLET, FILM COATED10004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57896-304STOOL SOFTENER WITH LAXATIVE (DOCUSATE SODIUM AND SENNOSIDES) TABLET, FILM COATED [GERI-CARE PHARMACEUTICAL CORP]4Current NDC, Legacy NDC, 2 package rows20231207_99fe8064-23f4-5d94-e053-2995a90a6641.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-304-01EA - Each57896-30415775618-2662-4fcc-8493-78a0d700e66312020-03-10
57896-304-10EA - Each57896-3047c8fa10f-02af-4f61-8986-3f5a3eba04c212020-08-06

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
57896-30457896-304-01, 57896-304-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
HYPROMELLOSES3NXW29V3WOIACT
FD&C BLUE NO. 2L06K8R7DQKIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SENNOSIDES3FYP5M0IJXACTIB
DOCUSATE SODIUMF05Q2T2JA0ACTIB
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEO7TSZ97GEPIACT
FD&C RED NO. 40WZB9127XOAIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TALC7SEV7J4R1UIACT

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
Stool Softener with LaxativeDOCUSATE SODIUM AND SENNOSIDESGeri-Care Pharmaceutical Corp99fe8064-23f4-5d94-e053-2995a90a66412023-12-06WarningsExact identifier
ndc (package): 57896-304-01
ndc (package): 57896-304-10
ndc (product): 57896-304
ndc11 (package): 57896030410
ndc11 (package): 57896030401
spl id: 0bdcf009-4dd7-e3d1-e063-6394a90ace29
spl set id: 99fe8064-23f4-5d94-e053-2995a90a6641

Reported adverse events (FAERS/openFDA)#

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