Indications and uses
for temporary relief of occasional constipation and irregularity this product generally produces bowel movement in 12 to 72 hours
for temporary relief of occasional constipation and irregularity this product generally produces bowel movement in 12 to 72 hours
take with a glass of water adults and children 12 years and over 1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses. children 2 and under 12 years of age 1 softgel daily children under 2 years of age ask a doctor
Docusate Sodium 100 mg
Stool softener laxative
Ask a doctor before use if you have
Ask a doctor or pharmacist before use if you are presently taking mineral oil
Stop use and ask a doctor if
If pregnant or breast-feeding, ask a health professional before use.
take with a glass of water
| adults and children 12 years and over | 1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses. | |
| children 2 and under 12 years of age | 1 softgel daily | |
| children under 2 years of age | ask a doctor |
FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, sorbitol special, citric acid, purified water and white edible ink
each softgel contains: sodium 5 mg
store at room temperature 15°-30°C (59°-86°F)
protect from excessive humidity
| adults and children 12 years and over | 1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses. |
| children 2 and under 12 years of age | 1 softgel daily |
| children under 2 years of age | ask a doctor |
In case of overdose, get medical help or contact a Poison Control Center right away.
DOCUSATE SODIUM CAPSULES, 100 mg
Quantity : 20000 Capsules
NDC. No : 84328-001
IMPORTANT:
Inspect immediate upon receipt.
This is a bulk shipment, intended for further processing only.
Protect from heat, humidity, and light. Do not refrigerate.
Store at 15-30°C (59-86°F)
CAUTION : FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e2db08c6-133f-4f4f-afb4-e90a2418d6f6 | Product name | 1 | 20230320 |
| ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906 | Product name | 7 | 20210625 |
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| 11ed6f83-cdd2-4637-8379-b1a1d3ae3cde | Product name | 1 | 20181101 |
| 86c45a79-b9f0-4476-a27c-6e10db098497 | Product name | 1 | 20180125 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 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 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 84328-001-01 | 2025-07-29 | C162847 | 48780-1 | 3b156c62-2b9e-fb37-e063-e6dba90a4e07 | 188d20f5-43de-d52a-e063-6394a90a451a |
| 84328-001-02 | 2025-07-29 | C162847 | 48780-1 | 3b156c62-2b9e-fb37-e063-e6dba90a4e07 | 188d20f5-43de-d52a-e063-6394a90a451a |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 84328-001-01 | DOCUSATE SODIUM 100MG | 1 in 1 BOX | CAPSULE, LIQUID FILLED | 1 | 2 | |
| 84328-001-01 | DOCUSATE SODIUM 100MG | 20000 in 1 BAG | CAPSULE, LIQUID FILLED | 20000 | 2 | |
| 84328-001-02 | DOCUSATE SODIUM 100MG | 1 in 1 BOX | CAPSULE, LIQUID FILLED | 1 | 2 | |
| 84328-001-02 | DOCUSATE SODIUM 100MG | 15000 in 1 BAG | CAPSULE, LIQUID FILLED | 15000 | 2 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 84328-001 | DOCUSATE SODIUM 100MG (DOCUSATE SODIUM 100MG- DOCUSATE SODIUM CAPSULE, LIQUID FILLED) CAPSULE, LIQUID FILLED [SHANDONG ROSEMED BIOOHARM LLC] | 2 | 4 package rows | 20240827_188d20f5-43de-d52a-e063-6394a90a451a.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 84328-001 | 84328-001-01, 84328-001-02 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| GELATIN | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| SORBITOL | 506T60A25R | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| WATER | 059QF0KO0R | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| DOCUSATE SODIUM | F05Q2T2JA0 | ACTIB |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
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 |
|---|---|---|---|---|---|---|
| 2091a352-e44b-2bba-e063-6294a90a00f8 | 188d20f5-43de-d52a-e063-6394a90a451a | 2024-08-26 | Warnings | 2091a352-e44b-2bba-e063-6294a90a00f8 188d20f5-43de-d52a-e063-6394a90a451a |
Adverse event summaries are temporarily unavailable. Other product information remains available.