Stool Softener with Stimulant Laxative

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

Active ingredients (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Docusate sodium 50 mg

Sennosides 8.6 mg

Purpose

OTC - PURPOSE SECTION

Stool softener

Stimulant laxative

Uses

INDICATIONS & USAGE SECTION

• for overnight relief from occasional constipation (irregularity)
• generally produces bowel movement in 6 to 12 hours

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

• laxative products for longer than 1 week unless directed by a doctor
• if you are now 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 lasts over a period of  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 may indicate a serious condition.

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

• take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses.

adults and children 12 years and older	take 2-4 tablets daily
children 6 to under 12 years of age	take 1-2 tablets daily
children 2 to under 6 years of age	take up to 1 tablet daily
children under 2	ask a doctor

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #2 aluminum lake, FD&C red # 40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, talc, 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 THE ACTIVE INGREDIENTS OF COLACE®  2-IN-1*

STOOL SOFTENER

With Stimulant Laxative

Docusate sodium 50 mg

Sennosides 8.6 mg

Relieves Constipation

TABLETS

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

†This product is not manufactured or distributed by Avrio Health L.P., distributor of Colace® 2-IN-1.

DISTRIBUTED BY: MIDWOOD BRANDS, LLC

500 VOLVO PARKWAY,

CHESAPEAKE, VA 23320

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

Products#

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

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

• Stool Softener with Stimulant Laxative
• Docusate sodium, Sennosides
• DOCUSATE SODIUM
• DOCUSATE
• SENNOSIDES
• CROSCARMELLOSE SODIUM
• DIBASIC CALCIUM PHOSPHATE DIHYDRATE
• HYPROMELLOSES
• MAGNESIUM STEARATE
• CELLULOSE, MICROCRYSTALLINE
• TALC
• TITANIUM DIOXIDE
• SILICON DIOXIDE
• ALUMINUM OXIDE
• FD&C BLUE NO. 2
• FD&C RED NO. 40
• POLYETHYLENE GLYCOL, UNSPECIFIED

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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.