Drug Facts

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 (1-800-222-1222) 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 1-877-753-3935 Monday-Friday 9AM-5PM EST

HOW SUPPLIED

How Supplied Section

Docusate Sodium 250mg Softgel Capsules

• NDC 71335-2313-1: 30 in a BOTTLE
• NDC 71335-2313-2: 60 in a BOTTLE
• NDC 71335-2313-3: 100 in a BOTTLE
• NDC 71335-2313-4: 7 in a BOTTLE
• NDC 71335-2313-5: 90 in a BOTTLE

Repackaged/Relabeled by:
Bryant Ranch Prepack
Burbank, CA 91504

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Docusate Sodium 250mg Softgel Capsules

Product Linked Resources#

Resource, Code type, Value table

Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	Data Matrix	(01)00371335231316(21)0123456789(17)280720(10)208820	GTIN-14: 00371335231316 GTIN-12: 371335231316 UPC-A: 371335231316 EAN-13: 0371335231316 GTIN storage (14 digits): 00371335231316	lbl713352313.jpg
QR code link	QR Code	dailymed.nlm.nih.gov/dailymed/search.cfm?adv=1&query=NDC:71335-2313-1		lbl713352313.jpg
Data code	Code 128	7133523131		lbl713352313.jpg

DailyMed Billing Units#

Products#

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

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

• Stool Softener Laxative
• Docusate Sodium
• DOCUSATE
• FD&C RED NO. 40
• FD&C YELLOW NO. 6
• GELATIN, UNSPECIFIED
• 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

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 · 2 matching rows.

Reported adverse events (FAERS/openFDA)#

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