Indications and uses
for relief of occasional constipation (irregularity) this product generally produces bowel movement in 12 to 72 hours
Stool Softener Laxative
- Manufacturer
- CVS Pharmacy
- Effective date
- 2024-03-07
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-06-01 00:09:32
Label at a glance#
ProductStool Softener Laxative
Active ingredientDOCUSATE SODIUM
Label structure10 sections
Dosage and administration
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
Storage and handling
each softgel contains : sodium 6 mg store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each softgel)
Docusate sodium 100 mg
Purpose
Stool softener laxative
Uses
- for relief of occasional constipation (irregularity)
- this product generally produces bowel movement in 12 to 72 hours
Warnings
Ask a doctor before use if you have
- stomach pain
- nausea
- vomiting
- a sudden change in bowel habits that lasts over 14 days
Ask a doctor or Pharmacist before use if you are
presently taking mineral oil.
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 laxative for more than 1 week
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- 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
- each softgel contains: sodium 6 mg
- store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)
Inactive ingredients
D&C red #33*, edible ink, FD&C blue #1*, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol*, purified water, sorbitan, sorbitol, titanium dioxide
*contains one or more of these ingredients
Questions or comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
Compare to the active ingredient in Phillips'® Stool Softener**
Stool Softener
DOCUSATE SODIUM, 100 mg
Stool Softener Laxative
Relieves constipation
Gentle, dependable relief
Stimulant-free
Cramp-free
SOFTGELS
**This product is not manufactured or distributed by Bayer HealthCare LLC, distributor of Phillips'® 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: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
CVS.com®
Product Label
DailyMed RxNorm Mappings#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69842-579-30 | Stool Softener Laxative | 30 in 1 BOTTLE, PLASTIC | CAPSULE, LIQUID FILLED | 30 | 5 | |
| 69842-579-30 | Stool Softener Laxative | 1 in 1 BOX | CAPSULE, LIQUID FILLED | 1 | 5 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- 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
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69842-579 | 69842-579-30 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DOCUSATE SODIUM | F05Q2T2JA0 | ACTIB |
| D&C RED NO. 33 | 9DBA0SBB0L | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| GELATIN | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITAN | 6O92ICV9RU | IACT |
| SORBITOL | 506T60A25R | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | 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 | CVS Pharmacy | 849b057a-dc46-423c-a2f4-b01f135a3803 | 2024-03-07 | Warnings | 69842-579-30 69842-579 69842057930 7e54f832-20de-473f-8c69-3296879277ef 849b057a-dc46-423c-a2f4-b01f135a3803 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.