Indications and uses
relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours
Docusate Sodium capsule, liquid filled (single-tone)
- Manufacturer
- AiPing Pharmaceutical, Inc. | Anshi Pharmaceutical (Zhongshan) Inc.
- Effective date
- 2019-11-11
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 00:01:59
Label at a glance#
ProductDocusate Sodium
Active ingredientDOCUSATE SODIUM
Label structure8 sections
Dosage and administration
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
Label contents#
Full prescribing information#
ACTIVE INGREDIENTS (IN EACH SOFTGEL)
Docusate Sodium 100 mg
PURPOSE
Stool softener
USES
- relieves occasional constipation (irregularity)
- generally produces bowel movement in 12 to 72 hours
WARNINGS
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 lasts 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 signs of a serious condition.
- you need to use a stool softener 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 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 INFORMATION
- each softgel contains: sodium 6 mg
- Store at room temperature 15-30°C
INACTIVE INGREDIENTS
D&C Red #33, FD&C red # 40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan solution and white edible ink.
PRINCIPAL DISPLAY PANEL-SHIPPING LABEL
Docusate Sodium Softgels, USP 100mg (Single-Tone)
Quantity : 19000 Softgels
NDC. No : 11788-024-00
WARNING:
KEEP OUT OF THE REACH OF CHILDREN. THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY. CONTENTS SHOULD BE REPACKAGED IMMEDIATELY AND LABELED IN STRICK CONFORMANCE WITH THE FOOD DRUG & COSMETIC ACT AND REGULATIONS THEREUNDER.
Products#
Every source-derived product name is available through these pages.
- Docusate Sodium
- FD&C RED NO. 40
- GELATIN
- GLYCERIN
- PROPYLENE GLYCOL
- SORBITOL
- D&C RED NO. 33
- FD&C YELLOW NO. 6
- WATER
- POLYETHYLENE GLYCOL, UNSPECIFIED
- DOCUSATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 11788-024 | 11788-024-00 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GELATIN | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SORBITOL | 506T60A25R | IACT |
| D&C RED NO. 33 | 9DBA0SBB0L | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| WATER | 059QF0KO0R | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| DOCUSATE SODIUM | F05Q2T2JA0 | 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 |
|---|---|---|---|---|---|---|
| c3296247-57fe-972e-e053-2995a90acfa9 | 59b9d247-4e9f-54a3-e053-2a91aa0a1ad1 | 2021-05-25 | Warnings | 59b9d247-4e9f-54a3-e053-2a91aa0a1ad1 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.