Docusate Sodium

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

Active ingredient (in each liquid-filled capsule)

OTC - ACTIVE INGREDIENT SECTION

Docusate sodium 100 mg

Purpose

OTC - PURPOSE SECTION

Stool softener laxative

Uses

INDICATIONS & USAGE SECTION

• relieves occasional constipation (irregularity)
• generally produces bowel movement in 12 to 72 hours

Warnings

WARNINGS SECTION

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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

presently taking mineral oil.

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

• do not take more than directed
  
• take with a glass of water
• 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 to 3 capsules daily
children 2 to under 12 years	take 1 capsule daily
children under 2 years	ask a doctor

Other information

STORAGE AND HANDLING SECTION

• each capsule contains: sodium 8 mg
  Very Low Sodium
  
• store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
• protect from light, heat and moisture
• TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
• see end flap for expiration date and lot number
  

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C red #40, FD&C yellow #6, gelatin, glycerin, isopropyl alcohol, light mineral oil, medium chain triglycerides, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan solution, white ink

Questions or comments?

OTC - QUESTIONS SECTION

 (800) 616-2471

Distributed By:

Cardinal Health

Dublin, OH 43017

L57365330921

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Docusate Sodium

Unit Dose

10 Softgels

DailyMed Billing Units#

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

• Docusate Sodium
• DOCUSATE
• FD&C RED NO. 40
• FD&C YELLOW NO. 6
• GELATIN, UNSPECIFIED
• GLYCERIN
• ISOPROPYL ALCOHOL
• LIGHT MINERAL OIL
• MEDIUM-CHAIN TRIGLYCERIDES
• POLYETHYLENE GLYCOL, UNSPECIFIED
• PROPYLENE GLYCOL
• WATER
• SORBITOL
• SORBITAN

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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.