Label at a glance#

ProductColace

Active ingredientDOCUSATE SODIUM

Label structure12 sections

Contacts and useful links#

PhoneLabel contact1-833-288-2684

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

OTC - PURPOSE SECTION

*Active ingredient*	*Purpose*
(in each soft gel)
Docusate sodium 50 mg...........	Stool softener

INDICATIONS & USAGE SECTION

Uses

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

OTC - DO NOT USE SECTION

Warnings

Do not use

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 movementafter use of a laxative. These could be signs of a serious condition.
you need to use a stool softener laxative for more than1 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 FORMS & STRENGTHS 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 1-6 soft gels daily
children 2 to under 12 years of age	take 1-3 soft gels daily
children under 2 years	ask a doctor

HOW SUPPLIED SECTION

Other information

each soft gel contains: sodium 3 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
gelatin, glycerin, PEG 400, propylene glycol, sorbitol

Soft gels are imprinted with edible dye-free ink.

Dist. by: Atlantis Consumer Healthcare Inc.
Bridgewater, NJ 08807

Questions? 1-833-288-2684

©2023 Atlantis Consumer Healthcare Inc.
Colace is a registered trademark of Atlantis Consumer Healthcare Inc.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Colace_®
Docusate Sodium, 50mg

CLEAR

Stool Softener

28 Clear soft gels

Do not use an imprinted seal under cap is missing
or damaged. See carton for additional information.

Dist. by: Atlantis Consumer Healthcare Inc. A0925
Bridgewater, NJ 08807 USA Questions? 1-833-288-2684

R54005

Lot No.:
Exp. Date:

Front Panel

#1 DOCTOR
RECOMMENDED
Stool Softener Brand

Colace_®
Docusate Sodium, 50mg

CLEAR

Stool Softener

√ Gentle, Effective
Constipation Relief
√ Stimulant-Free & Dye-Free

28 Clear Soft Gels

Side Panel

Colace_®
Docusate Sodium, 50mg

Retain this carton for
Important information.
For added savings, visit:
colacecapsules.com

Dist. by: Atlantis Consumer Healthcare Inc.
Bridgewater, NJ 08807 USA
Questions? 1-833-288-2684 A0925

©2025 Atlantis Consumer Healthcare Inc.
Colace is a registered trademark of Atlantis
Consumer Healthcare Inc.

R54009

Lot No.:

Exp. Date:

Colace_®
Docusate Sodium, 50mg

CLEAR

Stool Softener

42 Clear soft gels

Do not use an imprinted seal under cap is missing
or damaged. See carton for additional information.

Dist. by: Atlantis Consumer Healthcare Inc. A0925
Bridgewater, NJ 08807 USA Questions? 1-833-288-2684

R54008

Lot No.:
Exp. Date:

Front Panel

#1 DOCTOR
RECOMMENDED
Stool Softener Brand

Colace_®
Docusate Sodium, 50mg

CLEAR

Stool Softener

√ Gentle, Effective
Constipation Relief
√ Stimulant-Free & Dye-Free

42 Clear Soft Gels

Side Panel

Colace_®
Docusate Sodium, 50mg

√ Dye & Preservative-Free
√ Stimulant -Free
√ No Artificial Sweeteners

Retain this carton for
Important information.
For added savings, visit:
colacecapsules.com

R54009

Dist. by: Atlantis Consumer Healthcare Inc.
Bridgewater, NJ 08807 USA
Questions? 1-833-288-2684
©2025 Atlantis Consumer Healthcare Inc.
Colace is a registered trademark of Atlantis
Consumer Healthcare Inc.

Lot No.:

Exp. Date:

A0925

Colace_®
Docusate Sodium, 50mg

CLEAR

Stool Softener

60 Clear Soft Gels

Do not use an imprinted seal under cap is missing
or damaged. See carton for additional information.

Dist. by: Atlantis Consumer Healthcare Inc. A0925
Bridgewater, NJ 08807 USA Questions? 1-833-288-2684

R54010

Lot No.:
Exp. Date:

Front Panel

#1 DOCTOR
RECOMMENDED
Stool Softener Brand

Colace_®
Docusate Sodium, 50mg

CLEAR

Stool Softener

√ Gentle, Effective
Constipation Relief
√ Stimulant-Free & Dye-Free

60 Clear Soft Gels

Side Panel

Colace_®
Docusate Sodium, 50mg

√ Dye & Preservative-Free
√ Stimulant -Free
√ No Artificial Sweeteners

Retain this carton for
Important information.
For added savings, visit:
colacecapsules.com

R54011

Dist. by: Atlantis Consumer Healthcare Inc.
Bridgewater, NJ 08807 USA
Questions? 1-833-288-2684
©2025 Atlantis Consumer Healthcare Inc.
Colace is a registered trademark of Atlantis
Consumer Healthcare Inc.

Lot No.:

Exp. Date:

A0925

Colace_®
Docusate Sodium, 50mg

CLEAR

Stool Softener

100 Clear Soft Gels

Do not use an imprinted seal under cap is missing
or damaged. See carton for additional information.

Dist. by: Atlantis Consumer Healthcare Inc.
Bridgewater, NJ 08807 USA Questions?
1-833-288-2684

R54367

Lot No.:
Exp. Date:

A0925

Front Panel

VALUE SIZE

#1 DOCTOR
RECOMMENDED
Stool Softener Brand

Colace_®
Docusate Sodium, 50mg

CLEAR

Stool Softener

√ Gentle, Effective
Constipation Relief
√ Stimulant-Free & Dye-Free

100 Clear Soft Gels

Side Panel

Colace_®
Docusate Sodium, 50mg

√ Dye & Preservative-Free
√ Stimulant -Free
√ No Artificial Sweeteners

Retain this carton for Important information.
For added savings, visit: colacecapsules.com

Dist. by: Atlantis Consumer Healthcare Inc.
Bridgewater, NJ 08807 USA
Questions? 1-833-288-2684
©2025 Atlantis Consumer Healthcare Inc.
Colace is a registered trademark of Atlantis
Consumer Healthcare Inc.

Actual size bottle

R54366

Lot No.:
Exp. Date:

A0925

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0367618000076	GTIN-13: 0367618000076 EAN-13: 0367618000076 GTIN-12: 367618000076 UPC-A: 367618000076 GTIN storage (14 digits): 00367618000076	60-carton.jpg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67618-111-28	EA - Each	67618-111	83568077-dfe8-4169-b53c-57668d071625	1	2017-06-15

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

Colace
Docusate sodium
DOCUSATE
GELATIN, UNSPECIFIED
GLYCERIN
POLYETHYLENE GLYCOL 400
PROPYLENE GLYCOL
SORBITOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
67618-111	67618-111-28, 67618-111-42, 67618-111-60, 67618-111-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DOCUSATE SODIUM	F05Q2T2JA0	ACTIB
GELATIN, UNSPECIFIED	2G86QN327L	IACT
GLYCERIN	PDC6A3C0OX	IACT
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SORBITOL	506T60A25R	IACT

Source Document#

Source XML · Source PDF

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
12	2026-06-18	monthly-update	2026-07-17 21:34:44
11	2026-06-02	daily-update	2026-06-06 05:10:16
10	2026-03-04	full-release	2026-06-01 01:49:20

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Colace	DOCUSATE SODIUM	Atlantis Consumer Healthcare, Inc.	a1591da0-a1a9-9583-3cf5-788b8fee3814	2026-08-24		Exact identifier ndc (package): 67618-111-60 ndc (package): 67618-111-42 ndc (package): 67618-111-10 ndc (package): 67618-111-28 ndc (product): 67618-111 ndc11 (package): 67618011128 ndc11 (package): 67618011110 ndc11 (package): 67618011160 ndc11 (package): 67618011142 spl id: ec10da1a-de65-47d1-ae30-07ad97469e73 spl set id: a1591da0-a1a9-9583-3cf5-788b8fee3814

Reported adverse events (FAERS/openFDA)#

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

Colace Clear