Colace
- Manufacturer
- Atlantis Consumer Healthcare, Inc.
- Effective date
- 2026-09-09
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 9
- Source
- daily-update
- Hydrated at
- 2026-09-15 03:02:18
Label at a glance#
ProductColace
Active ingredientDOCUSATE SODIUM, SENNOSIDES
Label structure11 sections
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Drug Facts
| Active ingredient | Purpose |
| Docusate sodium 50 mg | Stool softener |
| Sennosides 8.6 mg | Stimulant laxative |
INDICATIONS & USAGE SECTION
Uses
- relieves occasional constipation (irregularity)
- generally produces bowel movement in 6 to 12 hours
OTC - DO NOT USE SECTION
Warnings
Do not use
- laxative products for longer than 1 week unless told to do so by a doctor
- if you are presently taking mineral oil, unless told to do so by a doctor
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have
- stomach pain
- nausea
- vomiting
- noticed a sudden change in bowel habits that lasts over 2 weeks
OTC - STOP USE SECTION
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.
OTC - PREGNANCY OR BREAST FEEDING SECTION
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.
DOSAGE & ADMINISTRATION SECTION
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 6 to under 12 years of age | take 1-2 tablets daily |
| children 2 to under 6 years of age | take up to 1 tablet daily |
| children under 2 | ask a doctor |
HOW SUPPLIED SECTION
Other information
- each tablet contains: calcium 7 mg, sodium 4 mg VERY LOW SODIUM
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F).
Keep tightly closed..
INACTIVE INGREDIENT SECTION
Inactive ingredients
croscarmellose sodium, dicalcium phosphate, FD&C Blue #1 Lake, FD&C Red #40 Lake, FD&C Yellow #6 Lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, polyethylene glycol, sodium benzoate, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide, triacetin.
Dist. by: Atlantis Consumer Healthcare inc.
Bridgewater, NJ 08801 USA
Questions? 1-833-286-2684
©2023 Atlantis Consumer Healthcare inc.
Colace is a registered trademark of Atlantis
Consumer Healthcare Inc.
A1023
R52504
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
#1
DOCTOR
RECOMMENDED
Stool Softener Brand
Colace®
Docusate Sodium, 50 mg
Sennosides 8.6 mg
2-IN-1
Stool Softener +
Stimulant Laxative
√ Gentle, Effective, & Dependable
√ Constipation Relief in 6 `12 hours
10 Tablets
Colace® 2-IN-1 Tablets
Docusate Sodium
Sennosides
Dist. by: Atlantis Consumer
Healthcare Inc.
LOT XXXXXX
EXP YYYY-MM
#1
DOCTOR
RECOMMENDED
Stool Softener Brand
Colace®
Docusate Sodium, 50 mg
Sennosides 8.6 mg
2-IN-1
Stool Softener +
Stimulant Laxative
√ Gentle, Effective, & Dependable
√ Constipation Relief in 6 `12 hours
30 Tablets
Retain this carton for
Important information
Dist. by: Atlantis Consumer Healthcare inc.
Bridgewater, NJ 08801 USA
Questions? 1-833-286-2684
©2023 Atlantis Consumer Healthcare inc.
Colace is a registered trademark of Atlantis
Consumer Healthcare Inc.
A1023
R52506
Colace®
Docusate Sodium
Sennosides
2-IN-1
Stool Softener +
Stimulant Laxative
30 Tablets
Do not use if imprinted seal under cap
is missing or damaged.
See carton for additional information
Dist. by: Atlantis Consumer Healthcare inc.
Bridgewater, NJ 08801 USA
Questions? 1-833-286-2684
©2023 Atlantis Consumer Healthcare inc.
Colace is a registered trademark of Atlantis
Consumer Healthcare Inc.
A1023
R52507
#1
DOCTOR
RECOMMENDED
Stool Softener Brand
Colace®
Docusate Sodium, 50 mg
Sennosides 8.6 mg
2-IN-1
Stool Softener +
Stimulant Laxative
√ Gentle, Effective, & Dependable
√ Constipation Relief in 6 `12 hours
Retain this carton for
Important information
For added savings, visit:
colacecapsules.com
Dist. by: Atlantis Consumer Healthcare inc.
Bridgewater, NJ 08801 USA
Questions? 1-833-286-2684
©2023 Atlantis Consumer Healthcare inc.
Colace is a registered trademark of Atlantis
Consumer Healthcare Inc.
A1023
R52508
60 Tablets
A1023
R52507
Colace®
Docusate Sodium
Sennosides
2-IN-1
Stool Softener +
Stimulant Laxative
60 Tablets
Do not use if imprinted seal under cap
is missing or damaged.
See carton for additional information
Dist. by: Atlantis Consumer Healthcare inc.
Bridgewater, NJ 08801 USA
Questions? 1-833-286-2684
©2023 Atlantis Consumer Healthcare inc.
Colace is a registered trademark of Atlantis
Consumer Healthcare Inc.
LOT:
EXP:
A1023
R52509
#1
DOCTOR
RECOMMENDED
Stool Softener Brand
Colace®
Docusate Sodium, 50 mg
Sennosides, 8.6 mg
2-IN-1
Stool Softener +
Stimulant Laxative
120 Tablets
Do not use if imprinted seal under
cap is missing or damaged.
R01129
A0826
Lot No.:
Exp. Date:
Dist. by: Atlantis Consumer Healthcare inc.
Bridgewater, NJ 08801 USA
Questions? 1-833-286-2684
©2026 Atlantis Consumer Healthcare inc.
Colace is a registered trademark of
Atlantis Consumer Healthcare Inc.
For added savings, visit:
colacecapsules.com
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 67618-121-04 | 2020-09-08 | C162847 | 48780-1 | 9d75b9d0-bcd7-f424-e053-dadaa90a57ce | Colace |
| 67618-121-04 | 2020-09-08 | C162847 | 48780-1 | 9d75b9d0-bcd7-f424-e053-dadaa90a57ce | Colace |
| 67618-121-04 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-bcd7-f424-e053-dadaa90a57ce | Colace |
| 67618-121-04 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-bcd7-f424-e053-dadaa90a57ce | Colace |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 67618-110-10 | EA - Each | 67618-110 | 97f64826-6da0-4225-8a8c-fd5c79f1d290 | 1 | 2017-06-15 |
| 67618-110-30 | EA - Each | 67618-110 | cc0b7afb-4dbc-4de0-9baf-f0a11bf2e3c2 | 1 | 2017-06-15 |
| 67618-110-60 | EA - Each | 67618-110 | 8ed23b60-d6db-4138-9d8d-ba01cc4db8ec | 1 | 2017-06-15 |
Products#
Every source-derived product name is available through these pages.
- Colace
- Docusate sodium - sennosides
- DOCUSATE SODIUM
- DOCUSATE
- SENNOSIDES
- CROSCARMELLOSE SODIUM
- ANHYDROUS DIBASIC CALCIUM PHOSPHATE
- FD&C BLUE NO. 1
- FD&C RED NO. 40
- FD&C YELLOW NO. 6
- HYPROMELLOSE, UNSPECIFIED
- MAGNESIUM STEARATE
- MALTODEXTRIN
- MICROCRYSTALLINE CELLULOSE 102
- MINERAL OIL
- POLYETHYLENE GLYCOL, UNSPECIFIED
- SODIUM BENZOATE
- SODIUM LAURYL SULFATE
- STARCH, CORN
- STEARIC ACID
- TALC
- TITANIUM DIOXIDE
- TRIACETIN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 67618-110 | 67618-110-10, 67618-110-30, 67618-110-60, 67618-110-20 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 8 | 2025-04-17 | full-release | 2026-06-01 00:59:21 |
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 |
|---|---|---|---|---|---|---|
| 33014ecb-19a8-ecec-e063-6294a90a7ab0 | 9fce5c4b-1e2e-47ef-13e5-c3bd5320d41b | 2025-04-17 | 9fce5c4b-1e2e-47ef-13e5-c3bd5320d41b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.