Indications and uses
relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours
Stool Softener Laxative
- Manufacturer
- Walgreens
- Effective date
- 2023-10-09
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:24:41
Label at a glance#
ProductStool Softener Laxative
Active ingredientDOCUSATE SODIUM
Label structure11 sections
Dosage and administration
take only by mouth. Doses may be taken as a single daily dose or in divided doses. adults and children12 years and over take 1-3 softgels daily children 2 to under 12 years of age take 1 softgel daily children under 2 years ask a doctor
Storage and handling
each softgel contains :sodium 6 mg store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each softgel)
Docusate sodium 100 mg
Purpose
Stool softener laxative
Uses
- relieves occasional constipation (irregularity)
- generally produces bowel movement in 12 to 72 hours
Warnings
Do not use
if you are presently taking mineral oil, unless told to do so 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.
- you need to use a laxative for more than 1 week
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 or in divided doses.
| adults and children12 years and over | take 1-3 softgels daily |
| children 2 to under 12 years of age | take 1 softgel daily |
| children under 2 years | ask a doctor |
Other information
- each softgel contains:sodium 6 mg
- store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)
Inactive ingredients
D&C red #33*, edible ink, FD&C blue #1*, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol*, purified water, sorbitan, sorbitol, titanium dioxide
*contains one or more of these ingredients
Questions or comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
Compare to the active ingredient in Colace® Regular Strength Stool Softener††
Stool Softener
DOCUSATE SODIUM 100 mg / STOOL SOFTENER LAXATIVE
REGULAR STRENGTH SOFTGELS
- Effective relief of constipation
- Gentle & dependable
- Stimulant free
SOFTGELS
††This product is not manufactured or distributed by Purdue Products L.P. , distributor of Colace® Regular Strength Stool Softener.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
walgreens.com
Product Label
PACKAGE LABEL
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0363-0016-06 | 2023-10-09 | C162847 | 48780-1 | f386c649-ebbb-0266-e053-dadaa90a7c1a | Drug Facts |
| 0363-0016-20 | 2023-10-09 | C162847 | 48780-1 | f386c649-ebbb-0266-e053-dadaa90a7c1a | Drug Facts |
| 0363-0016-40 | 2023-10-09 | C162847 | 48780-1 | f386c649-ebbb-0266-e053-dadaa90a7c1a | Drug Facts |
| 0363-0016-06 | 2023-01-30 | C162847 | 48780-1 | f386c649-ebbb-0266-e053-dadaa90a7c1a | Drug Facts |
| 0363-0016-20 | 2023-01-30 | C162847 | 48780-1 | f386c649-ebbb-0266-e053-dadaa90a7c1a | Drug Facts |
| 0363-0016-40 | 2023-01-30 | C162847 | 48780-1 | f386c649-ebbb-0266-e053-dadaa90a7c1a | Drug Facts |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0363-0016-06 | EA - Each | 0363-0016 | a0c53c75-8993-485b-ab51-4ba4e7eafad2 | 1 | 2022-06-06 |
Products#
Every source-derived product name is available through these pages.
- Stool Softener Laxative
- DOCUSATE SODIUM
- DOCUSATE
- D&C RED NO. 33
- FD&C BLUE NO. 1
- FD&C RED NO. 40
- FD&C YELLOW NO. 6
- GELATIN
- GLYCERIN
- POLYETHYLENE GLYCOL, UNSPECIFIED
- PROPYLENE GLYCOL
- WATER
- SORBITAN
- SORBITOL
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0363-0016 | 0363-0016-06, 0363-0016-20, 0363-0016-40 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DOCUSATE SODIUM | F05Q2T2JA0 | ACTIB |
| D&C RED NO. 33 | 9DBA0SBB0L | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| GELATIN | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITAN | 6O92ICV9RU | IACT |
| SORBITOL | 506T60A25R | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
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 |
|---|---|---|---|---|---|---|
| 754284b8-6e9b-4438-a0f6-5551e92ffe21 | 1a9739f8-1409-4120-8a5a-599d7222fa78 | 2023-10-09 | Warnings | 754284b8-6e9b-4438-a0f6-5551e92ffe21 1a9739f8-1409-4120-8a5a-599d7222fa78 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.