FDA.reportPublic FDA data

Colace

Manufacturer
Physicians Total Care, Inc.
Effective date
2010-03-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:30:25

Label at a glance#

ProductColace
Active ingredientdocusate sodium
Label structure13 sections

Indications and uses

relieves occasional constipation (irregularity) generally produces a bowel movement in 12 to 72 hours

Label contents#

Full prescribing information#

Drug Facts Colace 100 mg Active ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Docusate sodium 100 mg

Purpose

OTC - PURPOSE SECTION

Stool softener

Uses

INDICATIONS & USAGE SECTION

  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 12 to 72 hours

Do not use

OTC - DO NOT USE SECTION

  • if you are presently taking mineral oil, unless told to do so by a doctor

Ask a doctor before use if you have

OTC - ASK DOCTOR/PHARMACIST SECTION

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel movements that continues over a period of 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.
  • 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.

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 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
capsule daily
children under 2 yearsask a doctor

Other Information

SPL UNCLASSIFIED SECTION

  • each tablet 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 ingredients

INACTIVE INGREDIENT SECTION

D&C Red No. 33, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, PEG 400, propylene glycol, sorbitol, titanium dioxide

SPL UNCLASSIFIED SECTION

©2009 Purdue Products L.P.

Dist. by: Purdue Products L.P.
 Stamford, CT 06901-3431

302112-0B

SPL UNCLASSIFIED SECTION

Additional bar code label applied by:
Physicians Total Care, Inc.
Tulsa, Oklahoma      74146

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Colace

100mg

NDC 54868-2337-2

30 capsules

Colace Docusate Sodium 100mg
Colace Docusate Sodium 100mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1247756Colace 100 MG Oral CapsulePSN1
1115005docusate sodium 100 MG Oral CapsulePSN1
1247756docusate sodium 100 MG Oral Capsule [Colace]SBD1
1115005docusate sodium 100 MG Oral CapsuleSCD1
1247756Colace 100 MG Oral CapsuleSY1
1115005DOSS Sodium 100 MG Oral CapsuleSY1
1247756DOSS Sodium 100 MG Oral Capsule [Colace]SY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54868-2337-22019-09-24C16284748780-19350213a-42b6-c013-e053-90daa90a1393Colace 50 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54868-2337-2Colace30 in 1 BOTTLE, PLASTICCAPSULE301
54868-2337-2Colace1 in 1 CARTONCAPSULE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54868-2337COLACE (DOCUSATE SODIUM) CAPSULE [PHYSICIANS TOTAL CARE, INC.]12 package rows20111222_a6ffb144-0679-4702-8d97-7a78e176911e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54868-2337-2EA - Each54868-2337752d5d69-c339-412e-a9a2-6c445f014d1a12012-07-24
67618-101-01EA - Each67618-101f2ec6fdd-0022-4ae9-9cb1-1283a1d2759b12022-03-09
67618-101-10EA - Each67618-101676d3b90-74ba-48c7-af2d-57967b4b589012013-02-13
67618-101-30EA - Each67618-10131b331a1-c148-43af-8b5b-a8c2e1bca3e012012-07-24
67618-101-52EA - Each67618-101fa2dae37-1524-44fa-88c8-abc6ffaa91f112012-07-24
67618-101-60EA - Each67618-101019c7bf6-c568-44be-8113-3fe6d46ce30512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
docusate sodiumACTIVE INGREDIENTF05Q2T2JA01
docusateACTIVE MOIETYM7P27195AG1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54868-233754868-2337-2
67618-101

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
docusate sodiumF05Q2T2JA0ACTIB
D&C RED NO. 339DBA0SBB0LIACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
gelatin2G86QN327LIACT
glycerinPDC6A3C0OXIACT
polyethylene glycol 400B697894SGQIACT
propylene glycol6DC9Q167V3IACT
sorbitol506T60A25RIACT
titanium dioxide15FIX9V2JPIACT

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ColaceDOCUSATE SODIUMAtlantis Consumer Healthcare, Inc.7793fced-e8ee-44e2-b212-dd2a59a5f4622026-08-04WarningsExact identifier
ndc (product): 67618-101
a407b7b0-d214-4f75-9c48-669e3421d5c9a6ffb144-0679-4702-8d97-7a78e176911e2010-03-29WarningsExact identifier
spl id: a407b7b0-d214-4f75-9c48-669e3421d5c9
spl set id: a6ffb144-0679-4702-8d97-7a78e176911e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.