STOOL SOFTNER

Label at a glance#

Contacts and useful links#

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

Do not use

OTC - DO NOT USE SECTION

if you are presently taking mineral oil, unless told to do so 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.
• 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 only by mouth. Doses may be taken as a single daily dose or in divided doses.

adults and children 12 years and over	take 1-3 softgels daily
children 2 to under 12 years of age	take 1 softgel daily
children under 2 years	ask a doctor

Other information

STORAGE AND HANDLING SECTION

• Tamper Evident: do not use if safety seal under cap is broken or missing
• each capsule contains: sodium 6 mg
• VERY LOW SODIUM
• store at 25°C (77°F); excursions permitted between 15^o-30^oC (59^o-86^oF).

Keep tightly closed.

This Package for Households Without Young Children 

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C Red #33,Edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special, titanium dioxide 

Questions?

OTC - QUESTIONS SECTION

Adverse drug event call: (800) 687-0176 Mon- Fri 8 AM to 4 PM

* This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Colace®.

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-2375

NDC: 50090-2375-1 100 CAPSULE, LIQUID FILLED in a BOTTLE

NDC: 50090-2375-2 60 CAPSULE, LIQUID FILLED in a BOTTLE

NDC: 50090-2375-4 30 CAPSULE, LIQUID FILLED in a BOTTLE

Docusate Sodium

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

DailyMed Dashboard NDC Coverage#

DailyMed Billing Units#

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

• STOOL SOFTNER
• Docusate Sodium
• DOCUSATE
• D&C RED NO. 33
• FD&C RED NO. 40
• FD&C YELLOW NO. 6
• GELATIN, UNSPECIFIED
• GLYCERIN
• POLYETHYLENE GLYCOL, UNSPECIFIED
• SORBITOL
• TITANIUM DIOXIDE

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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.

Reported adverse events (FAERS/openFDA)#

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