Storage and handling
Other information each capsule contains: sodium 5 mg VERY LOW SODIUM store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F). Keep tightly closed.
Colace
- Manufacturer
- REMEDYREPACK INC.
- Effective date
- 2022-01-05
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:19:02
Label at a glance#
ProductColace
Active ingredientDOCUSATE SODIUM
Label structure11 sections
Contacts and useful links#
Label contents#
Full prescribing information#
DESCRIPTION SECTION
Drug Facts
Colace 100 mg
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each capsule):
Docusate sodium 100 mg
OTC - PURPOSE SECTION
Purpose
Stool softener
INDICATIONS & USAGE SECTION
Uses
- relieves occasional constipation (irregularity)
- generally produces bowel movement in 12 to 72 hours
WARNINGS AND PRECAUTIONS SECTION
Warnings
Do not use
- if you are presently taking mineral oil, unless told to do so by a doctor
OTC - ASK DOCTOR/PHARMACIST 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 - DO NOT 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.
- you need to use a stool softener laxative for more than 1 week
OTC - PREGNANCY OR BREAST FEEDING SECTION
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 children 12 years and over | take 1-3 capsules daily |
| children 2 to under 12 years of age | take 1 capsules daily |
| children under 2 years | ask a doctor |
STORAGE AND HANDLING SECTION
Other information
- each capsule contains: sodium 5 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
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
Repackaged and Distributed By:
Remedy Repack, Inc.
625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DRUG: Colace
GENERIC: Docusate sodium
DOSAGE: CAPSULE
ADMINSTRATION: ORAL
NDC: 70518-3319-0
COLOR: red
SHAPE: OVAL
SCORE: No score
SIZE: 12 mm
IMPRINT: RPC;053
PACKAGING: 30 in 1 BLISTER PACK
ACTIVE INGREDIENT(S):
- Docusate sodium 100mg in 1
INACTIVE INGREDIENT(S):
- D&C RED NO. 33
- FD&C RED NO. 40
- GELATIN
- GLYCERIN
- POLYETHYLENE GLYCOL 400
- PROPYLENE GLYCOL
- SORBITOL
- FD&C BLUE NO. 1
- FD&C YELLOW NO. 6
- TITANIUM DIOXIDE
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 70518-3319-0 | 2025-09-25 | C162847 | 48780-1 | 1030e365-3d2c-111a-e063-dadaa90a10e2 | 30d23151-3cd8-4a15-a1da-46aa4be8fb79 |
| 70518-3319-0 | 2024-01-30 | C162847 | 48780-1 | 1030e365-3d2c-111a-e063-dadaa90a10e2 | 30d23151-3cd8-4a15-a1da-46aa4be8fb79 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70518-3319 | COLACE (DOCUSATE SODIUM) CAPSULE [REMEDYREPACK INC.] | 1 | Legacy NDC | 20220106_30d23151-3cd8-4a15-a1da-46aa4be8fb79.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70518-3319-0 | EA - Each | 70518-3319 | ee76cf0e-92a5-4f61-9d51-8a03e532db49 | 1 | 2024-04-05 |
| 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 |
Products#
Every source-derived product name is available through these pages.
- Colace
- Docusate sodium
- D&C RED NO. 33
- FD&C RED NO. 40
- GELATIN
- GLYCERIN
- POLYETHYLENE GLYCOL 400
- PROPYLENE GLYCOL
- SORBITOL
- FD&C BLUE NO. 1
- FD&C YELLOW NO. 6
- TITANIUM DIOXIDE
- DOCUSATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70518-3319 | 70518-3319-0 |
| 67618-101 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| D&C RED NO. 33 | 9DBA0SBB0L | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GELATIN | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SORBITOL | 506T60A25R | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | 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 |
|---|---|---|---|---|---|---|
| Colace | DOCUSATE SODIUM | Atlantis Consumer Healthcare, Inc. | 7793fced-e8ee-44e2-b212-dd2a59a5f462 | 2026-08-04 | Warnings | 67618-101 |
| 0f3c949e-4b73-d922-e063-6394a90a7d97 | 30d23151-3cd8-4a15-a1da-46aa4be8fb79 | 2024-01-18 | Warnings | 30d23151-3cd8-4a15-a1da-46aa4be8fb79 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.