FDA.reportPublic FDA data

COLACE EXTRA STRENGTH

Manufacturer
Atlantis Consumer Healthcare Inc.
Effective date
2025-05-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:00:26

Label at a glance#

ProductCOLACE EXTRA STRENGTH STOOL SOFTNER
Active ingredientDOCUSATE SODIUM
Label structure9 sections

Indications and uses

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

Dosage and administration

adults and children 12 years of age and older take 1 softgel daily or as directed by a doctor. children under 12 years of age ask a doctor

Storage and handling

each softgel contains: sodium 15mg store at 20-25°C (68-77°F). Keep carton for full product information

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Docusate Sodium 250 mg

Purpose

OTC - PURPOSE SECTION

Stool softener

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Do not useif you are presently taking mineral oil, unless told to do so by a doctor.

Ask a doctor before use if you have

  • Stomach pain
  • Nausea
  • Vomiting
  • Noticed a sudden change in bowel habits that lasts over 2 weeks

Stop use and ask a doctor if

  • you have rectal bleeding or fail to have a bowel movement after use of a laxative.
    These can be signs of a serious condition
  • you need to use a stool softner laxative for more than 1 week

If pregnant or breast-feeding, ask a health care professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years of age and older

take 1 softgel daily or as directed by a doctor.

children under 12 years of age

ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each softgel contains:sodium 15mg
  • store at 20-25°C (68-77°F).
  • Keep carton for full product information

Inactive ingredients

INACTIVE INGREDIENT SECTION

gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol. Softgels are imprinted with edible, dye-free ink.

Questions? 

OTC - QUESTIONS SECTION

1-833-288-2684

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EXTRA STRENGTH

#1 DOCTOR RECOMMENDED

Stool Softner Brand

COLACE

Docusate Sodium, 250mg

EXTRA STRENGTH

Stool Softner

√Gentle & Effective

√Relieves Constipation

√Cramp & Stimulant-Free

√Dye & Preservative-Free √

60 Clear Soft Gels

Retain this carton for important information.

Dis. By: Atlantis Consumer Healthcare Inc.

Bridgewater, NJ 08807 USA

Questions? 1-833-288-2684

©2024 Atlantis Consumer Healthcare Inc.

Colace is a registered trademark of Atlantis Consumer Healthcare Inc.

A0824

Colace Extra strength 250mg 60 softgels
Colace Extra strength 250mg 60 softgels

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2692740Colace 250 MG Oral CapsulePSN3
1245468docusate sodium 250 MG Oral CapsulePSN3
2692740docusate sodium 250 MG Oral Capsule [Colace]SBD3
1245468docusate sodium 250 MG Oral CapsuleSCD3
2692740Colace 250 MG Oral CapsuleSY3
1245468DOSS Sodium 250 MG Oral CapsuleSY3
2692740DOSS sodium 250 MG Oral Capsule [Colace]SY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67618-201-12COLACE EXTRA STRENGTHSTOOL SOFTNER2 in 1 PACKAGECAPSULE, LIQUID FILLED23
67618-201-12COLACE EXTRA STRENGTHSTOOL SOFTNER60 in 1 BOTTLECAPSULE, LIQUID FILLED603
67618-201-60COLACE EXTRA STRENGTHSTOOL SOFTNER60 in 1 BOTTLECAPSULE, LIQUID FILLED603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67618-201COLACE EXTRA STRENGTH STOOL SOFTNER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [ATLANTIS CONSUMER HEALTHCARE INC.]3Current NDC, 3 package rows20250507_34e06b05-64a5-4b3e-af38-cdcd7c1d521b.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67618-20167618-201-60, 67618-201-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
GELATIN, UNSPECIFIED2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
CROSPOVIDONE (120 .MU.M)68401960MKIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
DOCUSATE SODIUMF05Q2T2JA0ACTIB

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COLACE EXTRA STRENGTH STOOL SOFTNERDOCUSATE SODIUMAtlantis Consumer Healthcare Inc.34e06b05-64a5-4b3e-af38-cdcd7c1d521b2025-05-01WarningsExact identifier
ndc (package): 67618-201-12
ndc (package): 67618-201-60
ndc (product): 67618-201
ndc11 (package): 67618020112
ndc11 (package): 67618020160
spl id: cb4d4f5a-9ae0-4cab-9806-017c6088f77f
spl set id: 34e06b05-64a5-4b3e-af38-cdcd7c1d521b

Reported adverse events (FAERS/openFDA)#

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