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 100 mg

Purpose

OTC - PURPOSE SECTION

Stool softener laxative

Uses

INDICATIONS & USAGE SECTION

• for relief of 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

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 14 days

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 softgels with a full glass (8 oz) of water

adults and children 12 years and older	take 1-3 softgels daily or as directed by a doctor. This dose may be taken as a single daily dose or in divided doses.
children 6 to under 12 years of age	take 1 softgel daily or as directed by a doctor
children under 6 years of age	ask a doctor

Other information

STORAGE AND HANDLING SECTION

• each softgel contains:sodium 5 mg
• store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

ammonium hydroxide, anhydrous citric acid, D&C red #33, ethyl alcohol, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, isopropyl alcohol, lecithin, mineral oil, n-butyl alcohol, polyethylene glycol, potassium hydroxide, 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 Phillips'® active ingredient*

Regular Strength

STOOL SOFTENER LAXATIVE

Docusate Sodium, 100 mg

Relieves occasional constipation

Stimulant Free

SOFTGELS

**This product is not manufactured or distributed by Bayer HealthCare LLC, distributor of Phillips'®.

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Distributed by: CVS Pharmacy, Inc.

One CVS Drive Woonsocket, RI 02895

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

Product Linked Resources#

DailyMed Package Descriptions#

Products#

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

DailyMed product names page 1 of 1 · 23 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
• ANHYDROUS CITRIC ACID
• ALCOHOL
• AMMONIA
• LECITHIN, SOYBEAN
• MINERAL OIL
• BUTYL ALCOHOL
• POTASSIUM HYDROXIDE
• ISOPROPYL ALCOHOL

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 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.