OTC - ACTIVE INGREDIENT SECTION
Drug Facts
Active ingredients (in each tablet)
Docusate sodium 50 mg
Sennosides 8.6 mg
Drug Facts
Active ingredients (in each tablet)
Docusate sodium 50 mg
Sennosides 8.6 mg
Purpose
Stool softener
Stimulant laxative
Uses
Warnings
Do not use
Ask a doctor beforeuse if you have
Stop use andask a doctor if you have rectal bleeding or fail to have abowel movement after use of a laxative. These could be signs of aserious condition.
If pregnantor breast-feeding, ask a health professional before use.
Keep out ofreach of children. In case of overdose, get medical help orcontact a Poison Control Center right away.
Directions
| adults and children12 years and over | take 2-4 tabletsdaily |
| children 6 to under12 years of age | take 1-2 tabletsdaily |
| children 2 to under6 years of age | take up to 1 tabletdaily |
| children under2 | ask a doctor |
Other information
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, sodiumbenzoate, sodium lauryl sulfate, starch, stearic acid, talc, titaniumdioxide, triacetin
©2020
Avrio HealthL.P.
305608-0A
Colace
Drug Facts
Active ingredient (in eachcapsule)
Docusate sodium 100 mg
Purpose:
Stool softener
Uses
Warnings
Do not use
Ask a doctor beforeuse if you have
Stop use andask a doctor if
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reachof children. In case of overdose, get medical help or contacta Poison Control Center right away.
Directions: Take only by mouth. Doses may be taken as a single dailydose or in divided doses.
| adults and children12 years and over | take 1-3 capsulesdaily |
| children 2 to under12 years of age | take 1 capsuledaily |
| children under2 years | ask a doctor |
Other information
Keep tightly closed.
Inactive ingredients
D&C Red No. 33, FD&C Blue #1, FD&C Red No. 40,
FD&C Yellow No. 6, gelatin, glycerin, PEG
400, propylene glycol, sorbitol, titanium
dioxide
©2018,
Avrio Health L.P.
304996-0A
| 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 |
| 67618-101-01 | EA - Each | 67618-101 | f2ec6fdd-0022-4ae9-9cb1-1283a1d2759b | 1 | 2022-03-09 |
| 67618-101-10 | EA - Each | 67618-101 | 676d3b90-74ba-48c7-af2d-57967b4b5890 | 1 | 2013-02-13 |
| 67618-101-30 | EA - Each | 67618-101 | 31b331a1-c148-43af-8b5b-a8c2e1bca3e0 | 1 | 2012-07-24 |
| 67618-101-52 | EA - Each | 67618-101 | fa2dae37-1524-44fa-88c8-abc6ffaa91f1 | 1 | 2012-07-24 |
| 67618-101-60 | EA - Each | 67618-101 | 019c7bf6-c568-44be-8113-3fe6d46ce305 | 1 | 2012-07-24 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 67618-110 | 67618-110-30 |
| 67618-101 | 67618-101-60 |
| 67618-372 | 67618-372-60 |
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| Colace | DOCUSATE SODIUM | Atlantis Consumer Healthcare, Inc. | 7793fced-e8ee-44e2-b212-dd2a59a5f462 | 2026-08-04 | Warnings | 67618-101-60 67618-101 67618010160 |
| 1a28ceb0-db46-48e1-916c-578e8d82298a | c5c61aa9-1fb2-96d9-f80f-cd6b44f2b2f6 | 2023-12-22 | 1a28ceb0-db46-48e1-916c-578e8d82298a c5c61aa9-1fb2-96d9-f80f-cd6b44f2b2f6 |
Adverse event summaries are temporarily unavailable. Other product information remains available.