DOCUSATE SODIUM
- Manufacturer
- DirectRx
- Effective date
- 2022-01-17
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:11:36
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Docusate Sodium 100 mg
OTC - PURPOSE SECTION
Stool softener laxative
DOSAGE & ADMINISTRATION SECTION
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 to 3 softgels daily.
children 2 to under 12 years of age take 1 softgel daily
children under 2 years ask a doctor
OTC - WHEN USING SECTION
relieves occasional constipation (irregularity)
generally produces bowel movement in 12 to 72 hours
WARNINGS SECTION
Do not use
if you are presently taking mineral oil, unless told to do so by a doctor.
Ask a doctor before use if you have
stomach pain
nausea
vomiting
noticed a sudden change in bowel habits that last over 2 weeks
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 a 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 (1-800-222-1222) right away.
OTHER SAFETY INFORMATION
each softgel contains: sodium 5 mg
store at 25ºC (77ºF);excursions permitted between 15-30ºC (59-86ºF)
INDICATIONS & USAGE SECTION
edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water sorbitan, sorbitol
OTC - QUESTIONS SECTION
Call 1-800-616-2471
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 72189-236-30 | EA - Each | 72189-236 | 03548c0a-3aea-468a-8115-5905f30483e2 | 1 | 2021-10-08 |
| 0904-6998-60 | EA - Each | 0904-6998 | d821c784-9742-4476-8dfb-c2f1c92a60eb | 1 | 2021-03-02 |
Products#
Every source-derived product name is available through these pages.
- DOCUSATE SODIUM
- FD&C RED NO. 40
- GELATIN
- SORBITOL
- GLYCERIN
- FD&C YELLOW NO. 6
- WATER
- MEDIUM-CHAIN TRIGLYCERIDES
- DOCUSATE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- PROPYLENE GLYCOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 72189-236 | 72189-236-30 |
| 0904-6998 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GELATIN | 2G86QN327L | IACT |
| SORBITOL | 506T60A25R | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| WATER | 059QF0KO0R | IACT |
| MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | IACT |
| DOCUSATE SODIUM | F05Q2T2JA0 | ACTIB |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | 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 |
|---|---|---|---|---|---|---|
| 07d9d78a-eff2-2e43-e063-6294a90ace12 | cbf97460-ea46-cf62-e053-2a95a90a3a99 | 2023-10-16 | Warnings | cbf97460-ea46-cf62-e053-2a95a90a3a99 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

