Stool Softener Laxative
- Manufacturer
- TARGET CORPORATION | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED
- Effective date
- 2025-06-25
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 01:03:52
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
Drug Facts
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each softgel)
Docusate sodium USP 100 mg
OTC - PURPOSE SECTION
Purpose
Stool softener
INDICATIONS & USAGE SECTION
Uses:
- relieves occasional constipation (irregularity)
- generally produces bowel movement in 12 to 72 hours
WARNINGS SECTION
Warnings
OTC - DO NOT USE SECTION
Do not use
- if you are presently taking mineral oil, unless told to do so by a doctor
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have
- stomach pain
- nausea
- vomiting
- noticed a sudden change in bowel habits that lasts over 2 weeks
OTC - STOP USE SECTION
Stop use and ask a doctor if
- 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 stool softener laxative for more than 1 week
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
DOSAGE & ADMINISTRATION SECTION
Directions:
- 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 SAFETY INFORMATION
Other information
- each capsule contains: sodium 6 mg
- keep tightly closed.
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F).
INACTIVE INGREDIENT SECTION
Inactive ingredients D&C red no. 33, FD&C blue no. 1, FD&C red no. 40, FD&C yellow no. 6, ferrosoferric oxide, gelatin, glycerin, polyethylene glycol 400, propylene glycol, purified water, shellac, sorbitol solution, titanium dioxide
OTC - QUESTIONS SECTION
Questions or comments? Call 1-800-910-6874
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 11673-512-66 | Stool Softener Laxative | 160 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 160 | 3 |
Products#
Every source-derived product name is available through these pages.
- Stool Softener Laxative
- Docusate Sodium
- D&C RED NO. 33
- FD&C RED NO. 40
- GELATIN
- GLYCERIN
- POLYETHYLENE GLYCOL 400
- WATER
- SORBITOL SOLUTION
- TITANIUM DIOXIDE
- DOCUSATE
- FERROSOFERRIC OXIDE
- FD&C BLUE NO. 1
- FD&C YELLOW NO. 6
- SHELLAC
- PROPYLENE GLYCOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 11673-512 | 11673-512-66 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| D&C RED NO. 33 | 9DBA0SBB0L | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GELATIN | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITOL SOLUTION | 8KW3E207O2 | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| DOCUSATE SODIUM | F05Q2T2JA0 | ACTIB |
| FERROSOFERRIC OXIDE | XM0M87F357 | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| SHELLAC | 46N107B71O | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Stool Softener Laxative | DOCUSATE SODIUM | TARGET CORPORATION | 28fce2e2-2101-df88-e063-6394a90aa3de | 2025-06-25 | Warnings | 11673-512-66 11673-512 11673051266 38643494-58ec-38e8-e063-6294a90a919f 28fce2e2-2101-df88-e063-6394a90aa3de |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
