Indications and uses
relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours
DOCUSATE SODIUM
- Manufacturer
- NuCare Pharmaceuticals,Inc.
- Effective date
- 2024-11-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 00:17:13
Label at a glance#
ProductDOCUSATE SODIUM
Active ingredientDOCUSATE SODIUM
Label structure10 sections
Dosage and administration
take only by mouth. Doses may be taken as a single daily dose or in divided doses. adults and children 12 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 7 mg store at 25ºC (77ºF); excursion permitted between 15-30ºC (59-86ºF)
Contacts and useful links#
Websitewww.majorpharmaceuticals.com
www.majorpharmaceuticals.com
www.majorpharmaceuticals.comLabel 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
- 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 bowel movement after using a laxative. These could be a sign of a serious condition.
- you need to use a stool softener laxative for more than 1 week
If pregnant or breast-feeding,
ask a health care professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center (1-800-2222-1222) right away.
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 | 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 7 mg
- store at 25ºC (77ºF); excursion permitted between 15-30ºC (59-86ºF)
Inactive ingredients
citric acid, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water sorbitol special, white edible ink
Questions or comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
HOW SUPPLIED:
Compare to the active ingredient in Colace® Regular Strength Stool Softener†
DOCUSATE SODIUM, 100 mg
NDC 68071-3438-3 BOTTLES OF 30
NDC 68071-3438-6 BOTTLES OF 60
STOOL SOFTENER LAXATIVE
Gentle, Dependable
Stimulant-free
SOFTGELS
†This product is not manufactured or distributed by Avrio Health L.P., distributor of Colace® Regular Strength Stool Softener..
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
DISTRIBUTED BY:
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268
(800) 616-2471
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68071-3438-3 | DOCUSATE SODIUM | 30 in 1 BOTTLE, PLASTIC | CAPSULE, LIQUID FILLED | 30 | 2 | |
| 68071-3438-6 | DOCUSATE SODIUM | 60 in 1 BOTTLE, PLASTIC | CAPSULE, LIQUID FILLED | 60 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68071-3438 | DOCUSATE SODIUM CAPSULE, LIQUID FILLED [NUCARE PHARMACEUTICALS,INC.] | 2 | Current NDC, 2 package rows | 20240815_fdf3c8e1-d554-4cdb-e053-6394a90a542e.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0904-7280-60 | EA - Each | 0904-7280 | 26a1e584-5c99-4037-9a6b-ca3b57d707f2 | 1 | 2023-03-13 |
| 0904-7280-80 | EA - Each | 0904-7280 | d88438cf-e71a-4f39-b013-ee79652343c4 | 1 | 2023-03-13 |
Products#
Every source-derived product name is available through these pages.
- DOCUSATE SODIUM
- FD&C RED NO. 40
- FD&C YELLOW NO. 6
- GELATIN
- POLYETHYLENE GLYCOL, UNSPECIFIED
- PROPYLENE GLYCOL
- WATER
- SORBITOL
- GLYCERIN
- CITRIC ACID MONOHYDRATE
- SORBITAN
- DOCUSATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68071-3438 | 68071-3438-6, 68071-3438-3 |
| 0904-7280 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| GELATIN | 2G86QN327L | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITOL | 506T60A25R | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| SORBITAN | 6O92ICV9RU | IACT |
| DOCUSATE SODIUM | F05Q2T2JA0 | ACTIB |
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 | Major Pharmaceuticals | 97561cd4-63d9-44c2-a3a3-ec668a09a4ed | 2025-10-31 | Warnings | 0904-7280 |
| DOCUSATE SODIUM | DOCUSATE SODIUM | NuCare Pharmaceuticals,Inc. | fdf3c8e1-d554-4cdb-e053-6394a90a542e | 2024-11-01 | Warnings | 68071-3438-3 68071-3438-6 68071-3438 68071343803 68071343806 0919f0ef-9139-b605-e063-6294a90af582 fdf3c8e1-d554-4cdb-e053-6394a90a542e |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.