Stool Softener and Laxative

Manufacturer
Spirit Pharmaceuticals LLC
Effective date
2022-12-05
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:52:02

Label at a glance#

ProductStool Softener and Laxative
Active ingredientDOCUSATE SODIUM, SENNOSIDES
Label structure16 sections

Indications and uses

• relieves occasional constipation (irregularity) • generally produces bowel movement in 6–12 hours

Dosage and administration

take preferably at bedtime or as directed by a doctor Age Starting Dosage Maximum Dosage adults & children 12 years of age & over 2 tablets once a day 4 tablets twice a day children 6 to under 12 years of age 1 tablet once a day 2 tablets twice a day children 2 to under 6 years ½ tablet once a day 1 tablet twice a day children under 2 years ask a doctor ask a doctor

Storage and handling

• each tablet contains: calcium 20 mg and sodium 6 mg • store at 25°C (77°F); excursions permitted between 15°–30°C (59°–86°F)

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

Laxative

Uses

INDICATIONS & USAGE SECTION

• relieves occasional constipation (irregularity) • generally produces bowel movement in 6–12 hours

Warnings

WARNINGS SECTION

• relieves occasional constipation (irregularity) • generally produces bowel movement in 6–12 hours

Do not use

OTC - DO NOT USE SECTION

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

Ask a doctor or pharmacist before use

OTC - ASK DOCTOR/PHARMACIST SECTION

if you are if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition.

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

take preferably at bedtime or as directed by a doctor

AgeStarting DosageMaximum Dosage
adults & children 12 years of age & over2 tablets once a day4 tablets twice a day
children 6 to under 12 years of age1 tablet once a day2 tablets twice a day
children 2 to under 6 years½ tablet once a day1 tablet twice a day
children under 2 yearsask a doctorask a doctor

Other information

STORAGE AND HANDLING SECTION

• each tablet contains: calcium 20 mg and sodium 6 mg
• store at 25°C (77°F); excursions permitted between 15°–30°C (59°–86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate, D&C Yellow No. 10, FD&C Yellow No. 6, hypromellose, magnesium stearate, microcrystalline cellulose, maltodextrin, polyethylene glycol 400, purified water, sodium benzoate, stearic acid, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-888-333-9792

Distributed by:

SPL UNCLASSIFIED SECTION

Cabinet Health P.B.C.

Pouch

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Stool Softener and LaxativeStool Softener and Laxative

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSN3
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCD3
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68210-4180-52024-01-30C16284748780-11030e365-24f4-111a-e063-dadaa90a10e2Stool Softener and Laxative

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68210-4180-5Stool Softener and Laxative50 in 1 POUCHTABLET, FILM COATED503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-4180STOOL SOFTENER AND LAXATIVE (DOCUSATE SODIUM AND SENNOSIDES) TABLET, FILM COATED [SPIRIT PHARMACEUTICALS LLC]3Legacy NDC, 1 package rows20221206_39f99d7f-8e7c-40ec-9c32-d14b3d36d8f7.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68210-418068210-4180-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 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
ef196dae-5fdf-08b5-e053-2995a90a5f0d39f99d7f-8e7c-40ec-9c32-d14b3d36d8f72022-12-05WarningsExact identifier
spl id: ef196dae-5fdf-08b5-e053-2995a90a5f0d
spl set id: 39f99d7f-8e7c-40ec-9c32-d14b3d36d8f7

Reported adverse events (FAERS/openFDA)#

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