FDA.reportPublic FDA data

Stool Softener

Manufacturer
TOP CARE (Topco Associates LLC)
Effective date
2024-06-19
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:00:28

Label at a glance#

ProductStool Softener
Active ingredientDOCUSATE SODIUM
Label structure10 sections

Indications and uses

for relief of occasional constipation and irregularity this product generally produces bowel movement in 12 to 72 hours

Dosage and administration

take with a glass of water adults and children 12 years and over  take 1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses.  children 2 to under 12 years of age   take 1 softgel daily  children under 2 years  ask a doctor 

Storage and handling

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

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 and 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 directed 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 more than 2 weeks

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you have rectal bleeding or no bowel movement after using 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

  • take with a glass of water
adults and children 12 years and over take 1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses. 
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 5 mg
  • store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

edible ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitan, sorbitol

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-888-423-0139

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO DULClOLAX® STOOL SOFTENER ACTIVE INGREDIENT**

Stool Softener

DOCUSATE SODIUM 100 mg • STOOL SOFTENER LAXATIVE

Fast, dependable relief of occasional constipation

SOFTGELS

**This product is not manufactured or distributed by Chattem, Inc., distributor of Dulcolax® Stool Softener

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 TOPCO ASSOCIATED LLC

ELK GROVE VILLAGE, IL 60007

topcare@topco.com

www.topcarebrand.com

Product Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TOPCARE Stool Softener
TOPCARE Stool Softener

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-86236800-862-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
DOCUSATE SODIUMF05Q2T2JA0ACTIB
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITAN6O92ICV9RUIACT
SORBITOL506T60A25RIACT

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e897f55f-a58d-4678-b664-7ade46b96fe467eb6a12-a390-4f55-a99a-0bde9db44e4f2024-06-19WarningsExact identifier
spl id: e897f55f-a58d-4678-b664-7ade46b96fe4
spl set id: 67eb6a12-a390-4f55-a99a-0bde9db44e4f

Reported adverse events (FAERS/openFDA)#

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