Indications and uses
relieves occasional constipation (irregularity) generally produces bowel movement in 6-12 hours
STOOL SOFTENER
- Manufacturer
- CVS
- Effective date
- 2024-12-17
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 8
- Source
- full-release
- Hydrated at
- 2026-06-01 00:49:38
Label at a glance#
ProductSTOOL SOFTENER
Active ingredientDOCUSATE SODIUM, SENNOSIDES
Label structure10 sections
Dosage and administration
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 of age or over take 2-4 softgels daily children 6 to under 12 years of age take 1-2 softgels daily children 2 to under 6 years of age take upto 1 softgel daily children under 2 ask a doctor
Storage and handling
each softgel contains: calcium 2 mg and sodium 3 mg store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) Keep tightly closed
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
DRUG FACTS
OTC - PURPOSE SECTION
| Active ingredients (in each softgel) | Purpose |
| Docusate sodium 50 mg | Stool softener |
| Sennosides 8.6 mg | Stimulant Laxative |
Uses
- relieves occasional constipation (irregularity)
- generally produces bowel movement in 6-12 hours
WARNINGS SECTION
Warnings
OTC - DO NOT USE SECTION
Do not use
- laxative products for longer than 1 week unless told to do so by a doctor
- 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 may indicate a serious condition.
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.
Directions
- 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 of age or over | take 2-4 softgels daily |
| children 6 to under 12 years of age | take 1-2 softgels daily |
| children 2 to under 6 years of age | take upto 1 softgel daily |
| children under 2 | ask a doctor |
Other information
- each softgel contains: calcium 2 mg and sodium 3 mg
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- Keep tightly closed
Inactive ingredients
Aerosil, beeswax, FD&C Red No.40, gelatin, glycerin, light liquid paraffin, povidone (PVP K-30), purified water, sodium carboxymethylcellulose, sorbitol solution, soya lecithin, titanium dioxide
Questions?
Call 1-888-333-9792 Monday-Friday 9AM-5PM EST
SPL UNCLASSIFIED SECTION
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
PRINCIPAL DISPLAY PANEL
♥CVSHealth™
Compare to the
active ingredients in
COLACE® 2-IN-1*
Liquid Filled Softgels
NDC 69842-319-60
Stool Softener
DOCUSATE SODIUM, 50 mg
SENNOSIDES, 8.6 mg
Plus stimulant laxative
Package Contains One Bottle
60 SOFTGELS
Actual Size
*This product is not manufactured or distributed by Purdue Products L.P., owner of the
registered trademark COLACE® 2-IN-1.
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6084a4f4-5437-c9a5-caec-5361ee075a59 | Product name | 1 | 20140508 |
| 90c5639a-61b0-88d6-ddcf-21888e94869a | Product name | 1 | 20140508 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69842-319-60 | STOOL SOFTENER | 1 in 1 CARTON | CAPSULE, GELATIN COATED | 1 | 8 | |
| 69842-319-60 | STOOL SOFTENER | 60 in 1 BOTTLE, PLASTIC | CAPSULE, GELATIN COATED | 60 | 8 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- STOOL SOFTENER
- DOCUSATE SODIUM AND SENNOSIDES
- SILICON DIOXIDE
- YELLOW WAX
- FD&C RED NO. 40
- GELATIN
- GLYCERIN
- LIGHT MINERAL OIL
- POVIDONE K30
- WATER
- CARBOXYMETHYLCELLULOSE SODIUM
- SORBITOL
- LECITHIN, SOYBEAN
- TITANIUM DIOXIDE
- DOCUSATE SODIUM
- DOCUSATE
- SENNOSIDES
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69842-319 | 69842-319-60 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| YELLOW WAX | 2ZA36H0S2V | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GELATIN | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| LIGHT MINERAL OIL | N6K5787QVP | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| WATER | 059QF0KO0R | IACT |
| CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | IACT |
| SORBITOL | 506T60A25R | IACT |
| LECITHIN, SOYBEAN | 1DI56QDM62 | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| DOCUSATE SODIUM | F05Q2T2JA0 | ACTIB |
| SENNOSIDES | 3FYP5M0IJX | ACTIB |
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 |
|---|---|---|---|---|---|---|
| 297dd92c-c032-28e2-e063-6294a90a70e4 | 271f134b-de73-415e-9c5e-a18267b765bc | 2024-12-17 | Warnings | 297dd92c-c032-28e2-e063-6294a90a70e4 271f134b-de73-415e-9c5e-a18267b765bc |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.