Active Ingredients And Purpose
Active ingredient (in each softgel)
Docusate Sodium 100 mg
Purpose
Stool Softner
Docusate Sodium 100mg
- Set ID
- 31e711c1-24a0-4b57-9f03-3fc22c6bcba0
- Manufacturer
- Spirit Pharmaceuticals LLC
- Effective date
- 2024-12-13
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 7
- Source
- full-release
- Hydrated at
- 2026-06-01 00:43:06
Key Label Information
Uses
Uses
for temporary relief of occasional constipation and irregularity this product generally produces a bowel movement within 12 to 72 hours
Warnings
WARNINGS SECTION
Warnings
Ask a doctor before use if you have
stomach pain, nausea or vomittiong a sudden change in bowel habits that lasts more than 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 laxative for more than 1 week.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding , ask a health professional before use.
Directions And Dosage
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 1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses Children 2 to under 12 years of age 1 softgel daily. Children under 2 years of age Ask a doctor
Other Label Information
Other information
Store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F) Keep tightly closed
Inactive ingredients
FD&C Red#40, FD&C Yellow#6, gelatin, glycerin, polyethylene glycol 400, propylene glycol, purified water, sorbitol solution, titanium dioxide.
Questions or comments?
1-888-333-9792
PDP
Cabinet: Stool Softener Docusate Sodium 100mg 75 Softgels
Products
- DOCUSATE
NDC Codes
Ingredients
| Name | UNII | Kind |
|---|---|---|
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| GELATIN | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| SORBITOL | 506T60A25R | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| DOCUSATE SODIUM | F05Q2T2JA0 | ACTIB |
Complete SPL Sections
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient (in each softgel)
Docusate Sodium 100 mg
Purpose
Stool Softner
Uses
for temporary relief of occasional constipation and irregularity this product generally produces a bowel movement within 12 to 72 hours
WARNINGS SECTION
Warnings
Ask a doctor before use if you have
stomach pain, nausea or vomittiong a sudden change in bowel habits that lasts more than 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 laxative for more than 1 week.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding , ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away.1(800)222-1222
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 1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses Children 2 to under 12 years of age 1 softgel daily. Children under 2 years of age Ask a doctor
Other information
Store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F) Keep tightly closed
Inactive ingredients
FD&C Red#40, FD&C Yellow#6, gelatin, glycerin, polyethylene glycol 400, propylene glycol, purified water, sorbitol solution, titanium dioxide.
Questions or comments?
1-888-333-9792
PDP
Cabinet: Stool Softener Docusate Sodium 100mg 75 Softgels
Source Document
Official SPL XML cached by FDA.report · DailyMed PDF
- XML object
- dailymed/31e711c1-24a0-4b57-9f03-3fc22c6bcba0/292d7a26-c25e-72df-e063-6394a90a5198.xml
- XML SHA-256
- 42ab5f97b1a26c9134ce60562854a23e50afebc370bd324e4b18c27abbf41077
- XML bytes
- 23743
Legacy File Index
| Folder | File | Date |
|---|---|---|
| otc | 292d7a26-c25e-72df-e063-6394a90a5198.xml | 2024-12-15 |
| otc | 0bf203ee-fd9b-552b-e063-6294a90a9000.xml | 2023-12-08 |
| otc | eeca812d-b15c-1e04-e053-2a95a90a274f.xml | 2022-12-02 |
| otc | d206319a-b662-26ed-e053-2995a90a6dea.xml | 2021-12-01 |
| otc | af099c10-9cf9-a435-e053-2995a90a7da9.xml | 2020-09-12 |
| otc | a97b52bb-3c8e-ad7c-e053-2995a90a5365.xml | 2020-07-03 |
| otc | Docusate.jpg | 2020-07-03 |