OTC - ACTIVE INGREDIENT SECTION
Each Tablet contains:
Docustate sodium 50 mg
Sennosides 8.6 mg
DOCUSATE SENNOSIDES
- Manufacturer
- DIRECTRX
- Effective date
- 2019-12-03
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:55:27
Label at a glance#
ProductDOCUSATE SENNOSIDES
Active ingredientDOCUSATE SODIUM, SENNOSIDES A AND B
Label structure8 sections
Label contents#
Full prescribing information#
INACTIVE INGREDIENT SECTION
INACTIVE INGREDIENTS: carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, d-c yellow#10 aluminum lake fd&c yelow#6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium benzoate, stearic acid, titanium dioxide
OTC - PURPOSE SECTION
stool softner, laxative
DOSAGE & ADMINISTRATION SECTION
Directions:
Take preferably at bedtime or as directed by a doctor. If you do not have a comfortable bowel movement by the second day, increase dose by one tablet (not to exceed maximum dosage) or decrease dose until you are comfortable.
Adults and children 12 years and over - starting dosage: 2 tablets once a day maximum dosage: 4 tablets twice a day
Children 6 to under 12 years - starting dosage: 1 tablet once a day maximum dosage: 2 tablets twice a day
Children to2 to under 6 years - starting dosage: 1/2 tablet once a day maximum dosage: 1 tablet twice a day
Children under 2 years - Ask a doctor
INDICATIONS & USAGE SECTION
Uses:
Relieves occasional constipation (irregularity); generally causes bowel movement in 6-12 hours
WARNINGS SECTION
WARNINGS:
Do not use this product
If you are presently taking mineral oil, unless directed by a doctor
Laxative products for longer than 1 week unless directed by a doctor
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 61919-771-60 | 2023-10-24 | C162847 | 48780-1 | f386c64a-0d20-0266-e053-dadaa90a7c1a | DOCUSATE SENNOSIDES |
| 61919-771-60 | 2023-01-30 | C162847 | 48780-1 | f386c64a-0d20-0266-e053-dadaa90a7c1a | DOCUSATE SENNOSIDES |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 49483-081-01 | EA - Each | 49483-081 | dbdee621-03c3-4233-a3c3-0f61f0511560 | 1 | 2015-08-04 |
| 49483-081-10 | EA - Each | 49483-081 | 0e50bc4b-d558-4109-9045-614e8955a3bc | 1 | 2015-08-04 |
Products#
Every source-derived product name is available through these pages.
- DOCUSATE SENNOSIDES
- STEARIC ACID
- SODIUM BENZOATE
- CARNAUBA WAX
- SILICON DIOXIDE
- MAGNESIUM STEARATE
- CELLULOSE, MICROCRYSTALLINE
- DOCUSATE SODIUM
- DOCUSATE
- SENNOSIDES A AND B
- D&C YELLOW NO. 10
- FD&C YELLOW NO. 6
- FOOD YELLOW 3 FREE ACID
- HYPROMELLOSES
- POLYETHYLENE GLYCOL, UNSPECIFIED
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 61919-771 | 61919-771-60 |
| 49483-081 |
Ingredients#
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| SENNA TIME S | DOCUSATE SODIUM-SENNOSIDES | TIME CAP LABORATORIES, INC | dc491692-8d3a-4ccd-a17d-4c630f122595 | 2025-02-08 | Warnings | 49483-081 |
| 0711bcf8-71b9-6bf7-e063-6294a90ab7f6 | 87aed85e-efb1-229f-e053-2a95a90ab8cd | 2023-10-06 | Warnings | 87aed85e-efb1-229f-e053-2a95a90ab8cd |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.