Indications and uses
relieves occasional constipation (irregularity) generally produces bowel movement in 6 to12 hours
Stool Softener Laxative
- Manufacturer
- QUALITY CHOICE (Chain Drug Marketing Association)
- Effective date
- 2024-09-04
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- full-release
- Hydrated at
- 2026-06-01 00:18:46
Label at a glance#
ProductStool Softener Laxative
Active ingredientDOCUSATE SODIUM, SENNOSIDES
Label structure10 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 childrens 6 to under 12 years of age take1-2 tablets daily children 2 to under 6 years of age take up to 1 tablet daily children under 2 ask a doctor
Contacts and useful links#
Websitewww.qualitychoice.com
www.qualitychoice.com
www.qualitychoice.comLabel contents#
Full prescribing information#
Active ingredients (in each tablet)
Docusate sodium 50 mg
Sennosides 8.6 mg
Purpose
Stool softener
Stimulant laxative
Uses
- relieves occasional constipation (irregularity)
- generally produces bowel movement in 6 to12 hours
Warnings
Do not use
- laxative products for longer than 1 week unless directed by a doctor
- if you are now 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 may indicate a serious condition.
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, preferably in the evening, or in divided doses.
| adults and children 12 years and over | take 2-4 tablets daily |
| childrens 6 to under 12 years of age | take1-2 tablets daily |
| children 2 to under 6 years of age | take up to 1 tablet daily |
| children under 2 | ask a doctor |
Other Information
- each tablet contains: calcium 30 mg
- each tablet contains: sodium 6 mg VERY LOW SODIUM
- store at 25ºC(77ºF), excursion permitted between 15-30ºC (59-86ºF)
Inactive ingredients
croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, talc, titanium dioxide
Questions or comments?
Call 1-800-935-2362 Monday-Friday 9AM-5PM EST
Principal Display Panel
*Compare to the Active Ingredients in Colace® 2-IN-1
STOOL SOFTENER
Plus Stimulant Laxative
Docusate sodium, 50 mg
Sennosides, 8.6 mg
Effective
Reliable
Comfortable
TABLETS
*This product is not manufactured or distributed by Avrio Health L.P., Distributor of Colace® 2-IN-1.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
Distributed by C.D.M.A. Inc.©
43157 W. 9 Mile Rd
Novi, MI 48375
Product Label
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 63868-884-01 | 2023-05-11 | C162847 | 48780-1 | f386c64a-0335-0266-e053-dadaa90a7c1a | DRUG FACTS |
| 63868-884-01 | 2023-01-30 | C162847 | 48780-1 | f386c64a-0335-0266-e053-dadaa90a7c1a | DRUG FACTS |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63868-884-01 | Stool Softener Laxative | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | 6 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63868-884 | STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM AND SENNOSIDES) TABLET [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] | 6 | Current NDC, Legacy NDC, 1 package rows | 20240906_19e10544-81f4-4c2d-8a63-238c562c2f5c.zip |
Products#
Every source-derived product name is available through these pages.
- Stool Softener Laxative
- docusate sodium and sennosides
- DOCUSATE SODIUM
- DOCUSATE
- SENNOSIDES
- CROSCARMELLOSE SODIUM
- DIBASIC CALCIUM PHOSPHATE DIHYDRATE
- FD&C BLUE NO. 2
- HYPROMELLOSES
- MAGNESIUM STEARATE
- CELLULOSE, MICROCRYSTALLINE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- SILICON DIOXIDE
- SODIUM BENZOATE
- STEARIC ACID
- TALC
- TITANIUM DIOXIDE
- ALUMINUM OXIDE
- FD&C RED NO. 40
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 63868-884 | 63868-884-01 |
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 |
|---|---|---|---|---|---|---|
| Stool Softener Laxative | DOCUSATE SODIUM AND SENNOSIDES | QUALITY CHOICE (Chain Drug Marketing Association) | 19e10544-81f4-4c2d-8a63-238c562c2f5c | 2024-09-04 | Warnings | 63868-884-01 63868-884 63868088401 d1f85142-3a8f-495d-b1fc-2467fd512710 19e10544-81f4-4c2d-8a63-238c562c2f5c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.