DOCUSATE SODIUM
- Manufacturer
- Direct_Rx
- Effective date
- 2020-01-20
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:45:10
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Docusate Sodium 100 mg
Purpose
Stool softener
INDICATIONS & USAGE SECTION
for prevention of dry, hard stools
for relief of occasional constipation
This product generally produces a bowel movement within 12 to 72 hours.
WARNINGS SECTION
Do not use
if you are currently taking mineral oil, unless directed by a doctor
when abdominal pain, nausea, or vomiting are present
for longer than 1 week, unless directed by a doctor
Ask a doctor before use if
if you notice a sudden change in bowel habits that persists over a period of 2 weeks.
Stop use and ask a doctor if
you have rectal bleeding
you fail to have a bowel movement after use
These could be signs of a serious condition.
If pregnant or breast-feeding,
ask a health care professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
adults and children over 12 years of age take 1 to 3 softgels preferably at bedtime
children 6-12 years of age take 1 softgel at bedtime
children under 6 years ask a doctor
OTHER SAFETY INFORMATION
each softgel contains: sodium 6 mg
store between 15º-30ºC (59º-86ºF)
INACTIVE INGREDIENT SECTION
edible white ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special.
OTC - QUESTIONS SECTION
1-800-645-2158
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 61919-459-60 | 2023-10-24 | C162847 | 48780-1 | d6a99b39-ba67-a426-e053-dadaa90af4c2 | DOCUSATE SODIUM |
| 61919-459-60 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-ba67-a426-e053-dadaa90af4c2 | DOCUSATE SODIUM |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 61919-459-30 | EA - Each | 61919-459 | 6661372f-c5b8-4668-b3f7-4c1311433bf5 | 1 | 2016-04-04 |
| 61919-459-71 | EA - Each | 61919-459 | e2138f19-4d5a-49f4-af53-feb66ebe8d4b | 1 | 2015-10-02 |
| 0536-3756-01 | EA - Each | 0536-3756 | 8fd965ad-aad1-4339-b7a2-362c0a1f3061 | 1 | 2012-07-24 |
| 0536-3756-10 | EA - Each | 0536-3756 | 3791905f-77b1-4557-9988-9c77fa97f976 | 1 | 2012-07-24 |
Products#
Every source-derived product name is available through these pages.
- DOCUSATE SODIUM
- PROPYLENE GLYCOL
- SORBITOL
- DOCUSATE
- GLYCERIN
- FD&C RED NO. 40
- FD&C YELLOW NO. 6
- FOOD YELLOW 3 FREE ACID
- POLYETHYLENE GLYCOL, UNSPECIFIED
- GELATIN
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 61919-459 | 61919-459-60 |
| 0536-3756 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SORBITOL | 506T60A25R | IACT |
| DOCUSATE SODIUM | F05Q2T2JA0 | ACTIB |
| GLYCERIN | PDC6A3C0OX | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| GELATIN | 2G86QN327L | IACT |
| WATER | 059QF0KO0R | 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 |
|---|---|---|---|---|---|---|
| 0749d384-6099-f2f6-e063-6394a90a8dac | 901a3592-b7e3-8adb-e053-2a95a90a5a80 | 2023-10-09 | Warnings | 901a3592-b7e3-8adb-e053-2a95a90a5a80 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
