Indications and uses
relieves occasional constipation (irregularity) this product generally produces bowel movement in 6 to 12 hours
Stool Softener with Laxative
- Manufacturer
- PHARMACY VALUE ALLIANCE, LLC | Geri-Care Pharmaceutical Corp
- Effective date
- 2024-11-28
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 20:48:29
Label at a glance#
ProductStool Softener with Laxative
Active ingredientSENNOSIDES, DOCUSATE SODIUM
Label structure8 sections
Dosage and administration
Take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses adults and children 12 years and over take 2-4 tablets daily children under 12 years of age ask a doctor
Storage and handling
each tablet contains: calcium 20 mg, sodium 3 mg store at controlled room temperature Tamper Evident: Do not use if imprinted seal under cap is missing or broken. product of India
Label contents#
Full prescribing information#
Active ingredient (in each tablet)
Docusate Sodium 50 mg
Sennosides 8.6 mg
Purpose
Stool softener
Stimulant laxative
Uses
- relieves occasional constipation (irregularity)
- this product generally produces bowel movement in 6 to 12 hours
Warnings
Do not use
- laxative products for longer than 1 week unless directed by a doctor
- if you are presently taking mineral oil, unless directed 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.
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.
Directions
- Take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses
| adults and children 12 years and over | take 2-4 tablets daily |
| children under 12 years of age | ask a doctor |
Other information
- each tablet contains: calcium 20 mg, sodium 3 mg
- store at controlled room temperature
- Tamper Evident: Do not use if imprinted seal under cap is missing or broken.
- product of India
Inactive ingredients
cellulose, croscarmellose sodium, dicalcium phosphate, FD&C blue #2 lake, FD&C red #40 lake, hypromellose, magnesium stearate, PEG, silica, talc, titanium dioxide.
Package Label
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Stool Softener with Laxative
- Docusate Sodium and Sennosides
- TALC
- POLYETHYLENE GLYCOL, UNSPECIFIED
- HYPROMELLOSES
- FD&C BLUE NO. 2
- TITANIUM DIOXIDE
- SENNOSIDES
- DOCUSATE SODIUM
- DOCUSATE
- MAGNESIUM STEARATE
- CELLULOSE, MICROCRYSTALLINE
- CROSCARMELLOSE SODIUM
- CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
- FD&C RED NO. 40
- SILICON DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68016-623 | 68016-623-01, 68016-623-25 |
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 |
|---|---|---|---|---|---|---|
| 27fe47d5-003b-b29a-e063-6394a90ac85f | 99ffa189-3e5a-cb91-e053-2a95a90a166e | 2024-11-28 | Warnings | 27fe47d5-003b-b29a-e063-6394a90ac85f 99ffa189-3e5a-cb91-e053-2a95a90a166e |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.