Stool Softener Laxative

Label at a glance#

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-877-753-3935

Websitewww.mygnp.comwww.mygnp.com

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Docusate sodium 100 mg

Purpose

OTC - PURPOSE SECTION

Stool softener laxative

Uses

INDICATIONS & USAGE SECTION

• relieves occasional constipation (irregularity)
• this product 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
• 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 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

• 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

• each softgel contains:sodium 6 mg
• store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

black iron oxide, D&C red #33, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, hypromellose,  polyethylene glycol, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

**Compare to Colace® Regular Strength Stool Softener active ingredient

Stool Softener

docusate sodium, 100 mg

Stool Softener Laxative

SOFTGELS

**This product is not manufactured or distributed by Avrio Health LLC., distributor of Colace® Regular Strength Stool Softener.

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

Distributed By AmerisourceBergen

1300 Morris Drive, Chesterbrook, PA 19087

www.mygnp.com

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
• D&C RED NO. 33
• FD&C BLUE NO. 1
• FD&C RED NO. 40
• FD&C YELLOW NO. 6
• GELATIN
• GLYCERIN
• POLYETHYLENE GLYCOL, UNSPECIFIED
• PROPYLENE GLYCOL
• WATER
• SORBITAN
• SORBITOL
• TITANIUM DIOXIDE
• HYPROMELLOSE, UNSPECIFIED
• FERROSOFERRIC OXIDE

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 · 1 matching rows.

Reported adverse events (FAERS/openFDA)#

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