FDA.reportPublic FDA data

STOOL SOFTENER

Manufacturer
SPIRIT PHARMACEUTICALS LLC
Effective date
2022-11-22
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:46:47

Label at a glance#

ProductSTOOL SOFTENER WITH STIMULANT LAXATIVE
Active ingredientDOCUSATE SODIUM, SENNOSIDES
Label structure13 sections

Indications and uses

■ relieves occasional constipation (irregularity) ■ generally produces bowel movement in 6-12 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 6 to under 12 years of age  take 1-2 tablets daily  children 2 to under 6 years of age  take up to 1 tablet daily  children under 2  ask a doctor

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredients (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)
■ generally produces bowel movement in 6-12 hours

WARNINGS SECTION

Warnings

Do not use

OTC - DO NOT USE SECTION

■ 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

OTC - ASK DOCTOR SECTION

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

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

Drug Facts (continued)

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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. 1-800-222-1222

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 over 		 take 2-4 tablets daily
 children 6 to under 12 years
of age 		 take 1-2 tablets daily
 children 2 to under 6 years
of age 		 take up to 1 tablet daily
 children under 2 ask a doctor

Other information

STORAGE AND HANDLING SECTION

■ each tablet contains: calcium 20 mg, 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, FD&C Red #40, hypermellose, magnesium
stearate, maltodextrin, microcrystalline cellulose, polyethylene
glycol-400, purified water, sodium benzoate, stearic acid,
titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-888-333-9792

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO THE ACTIVE
INGREDIENTS OF PERI-COLACE®†

FAMILY WELNESS

Stool Softener

with Stimulant Laxative

Docusate Sodium 50 mg
Sennosides 8.6 mg

Relieves
Constipation

ACTUAL SIZE

100 TABLETS

image descriptionimage description

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68210-303068210-3030-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C RED NO. 40WZB9127XOAIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
STEARIC ACID4ELV7Z65APIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
DOCUSATE SODIUMF05Q2T2JA0ACTIB
SENNOSIDES3FYP5M0IJXACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JIACT

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
0c027a3d-802b-53c7-e063-6294a90aa39774ffcb12-d94a-4250-a83b-ee6d20ab74092023-12-08WarningsExact identifier
spl set id: 74ffcb12-d94a-4250-a83b-ee6d20ab7409

Reported adverse events (FAERS/openFDA)#

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