Stool Softener

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

 Docusate sodium 250 mg

Purpose

OTC - PURPOSE SECTION

 Stool softener laxative

Uses

INDICATIONS & USAGE SECTION

• relieves occasional constipation (irregularity)
• this product generally produces a bowel movement within 12 to 72 hours

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

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 last 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.
• you need to use a 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.

Directions

DOSAGE & ADMINISTRATION SECTION

• adults and children 12 years of age and over: take 1 softgel daily or as directed by a doctor
• children under 12 years of age: ask a doctor

Other information

STORAGE AND HANDLING SECTION

• each softgel contains: sodium 13 mg
• store between 20-25ºC (68-77ºF); excursions permitted between 15-30ºC (59-86ºF)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, FD&C red #40, FD&C yellow #6, gelatin, glycerin, isopropyl alcohol, lecithin, mannitol, mineral oil, polyethylene glycol, propylene glycol, purified water, sorbitan, sorbitol, white ink 

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-888-423-0139

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EXTRA STRENGTH

Stool Softener

DOCUSATE SODIUM, 250 mg

STOOL SOFTENER LAXATIVE

• Stimulant-free
• Relief of occasional constipation

SOFTGELS

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY

TOPCO ASSOCIATES LLC

ITASCA, IL 60143 

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

Product Linked Resources#

DailyMed Package Descriptions#

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

• Stool Softener
• Docusate Sodium
• DOCUSATE
• FD&C RED NO. 40
• FD&C YELLOW NO. 6
• GELATIN
• GLYCERIN
• POLYETHYLENE GLYCOL, UNSPECIFIED
• PROPYLENE GLYCOL
• WATER
• SORBITOL
• ANHYDROUS CITRIC ACID
• ISOPROPYL ALCOHOL
• LECITHIN, SOYBEAN
• MANNITOL
• MINERAL OIL
• SORBITAN

NDC Codes#

Ingredients#

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

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

Source Document#

Source XML

Older Hydrated Versions#

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.

Reported adverse events (FAERS/openFDA)#

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