Indications and uses
relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours
Docusate Sodium
- Manufacturer
- Akron Pharma Inc.
- Effective date
- 2020-11-22
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:05:50
Label at a glance#
ProductDocusate Sodium
Active ingredientDocusate Sodium
Label structure8 sections
Dosage and administration
adults and children 12 years and over take 1-3 capsules once daily or in divided doses children 6 years to under 12 years take 1 capsule once daily children under 6 years ask a doctor
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient
(in each capsule)----------- Docusate sodium 100 mg
Purpose
Stool softener
Uses
- relieves occasional constipation (irregularity)
- generally produces bowel movement in 12 to 72 hours
Warnings
Do not use
- if you are currently taking mineral oil, unless directed by a doctor
Ask a doctor before use if you have
- stomach pain, nausea or vomiting
- noticed a sudden change in bowel habits that lasts over two weeks
Stop use and ask a doctor if
- you have rectal bleeding
- you fail to have a bowel movement after use of a laxative
- These could be signs of a serious condition.
- you need to use a stool softener laxative for more than one 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
| adults and children 12 years and over | take 1-3 capsules once daily or in divided doses |
| children 6 years to under 12 years | take 1 capsule once daily |
| children under 6 years | ask a doctor |
Other information
- each capsule contains sodium 7 mg
- store at room temperature 15o-30oC (59o-86oF) in a dry place
Questions?
Call +1(877) 255-6999, 8:30am - 4:30pm EST Monday - Friday
*Akron Pharma Inc is not affiliated with the owner of trademark Colace
Manufactured for:
Akron Pharma, Inc.
Fairfield, NJ 07004
Manufactured in U.S.A
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 71399-8020-1 | EA - Each | 71399-8020 | 083bfe8f-8036-4206-a3ac-9114daf1ad91 | 1 | 2021-03-02 |
Products#
Every source-derived product name is available through these pages.
- Docusate Sodium
- Docusate
- FD&C RED NO. 40
- FD&C YELLOW NO. 6
- GELATIN
- GLYCERIN
- POLYETHYLENE GLYCOL 400
- WATER
- SORBITOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 71399-8020 | 71399-8020-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Docusate Sodium | F05Q2T2JA0 | ACTIB |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| GELATIN | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITOL | 506T60A25R | 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 |
|---|---|---|---|---|---|---|
| d52fb599-362a-44fc-85d0-caa1b3c424d9 | 2a5f5ec9-c555-40a2-9d7c-cd491969fbc5 | 2022-01-23 | Warnings | 2a5f5ec9-c555-40a2-9d7c-cd491969fbc5 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.