Label at a glance#

ProductColace

Active ingredientDocusate sodium

Label structure11 sections

Storage and handling

Otherinformation 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.

Contacts and useful links#

PhoneLabel contact1-833-288-2684

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 todo 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 over2 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 than1 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 caseof overdose, get medical help or contact a Poison Control Center rightaway.

Directions: Take only by mouth. Dosesmay be taken as a single daily dose or in divided doses.

adults and children 12 yearsand over	take 1-3 capsules daily
children 2 to under 12 yearsof age	take 1 capsules daily
children under 2 years	ask a doctor

STORAGE AND HANDLING SECTION

Otherinformation

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

Avrio Health L.P.

304996-0A

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

#1 DOCTOR
RECOMMENDED
Stool Softener Brand

Colace_®
Docusate Sodium, 100mg

REGULAR
STRENGTH

Stool Softener
√ Gentle & Effective
√ Relieves Constipation
√ Cramp & Stimulant-free

10 Capsules

R54013

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.

Tamper Evident: Do not use if sealed
blister unit is broken or damaged.

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

A1125

Colace Docusate Sodium, 100mg

Regular Strength
Capsules 100 mg

Dist. by: Atlantis Consumer Healthcare Inc.

LOT XXXXXX EXP YYYY/MM

TO REMOVE TABLETS PUSH THROUGH
FROM OTHER SIDE. DO NOT USE IF
BLISTER SEAL IS BROKEN OR DAMAGED.

Distributed by:
Atlantis Consumer Healthcare Inc.
Bridgewater, NJ 08807 USA

#1 DOCTOR
RECOMMENDED
Stool Softener Brand

Colace_®
Docusate Sodium, 100mg

REGULAR
STRENGTH

Stool Softener
√ Gentle & Effective
√ Relieves Constipation
√ Cramp & Stimulant-free

30 Capsules

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.

A0925

R54016

Colace_®
Docusate Sodium, 100mg

REGULAR
STRENGTH

Stool Softener

30 Capsules

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

Each capsule contains: sodium 5 mg VERY LOW SODIUM

R54014

A0925

#1 DOCTOR
RECOMMENDED
Stool Softener Brand

Colace_®
Docusate Sodium, 100mg

REGULAR
STRENGTH

Stool Softener
√ Gentle & Effective
√ Relieves Constipation
√ Cramp & Stimulant-free

60 Capsules

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.

A0925

R54018

Colace_®
Docusate Sodium, 100mg

REGULAR
STRENGTH

Stool Softener

60 Capsules

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

Each capsule contains: sodium 5 mg VERY LOW SODIUM

R54017

A0925

VALUE SIZE

#1 DOCTOR
RECOMMENDED
Stool Softener Brand

Colace_®
Docusate Sodium, 100mg

REGULAR
STRENGTH

Stool Softener
√ Gentle & Effective
√ Relieves Constipation
√ Cramp & Stimulant-free

100 Capsules

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.

A1025

R54020

Lot No.:
Exp. Date:

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

Each capsule contains: sodium 5 mg VERY LOW SODIUM

A0925

R54019

Lot No.:

Exp. Date:

#1 DOCTOR
RECOMMENDED
Stool Softener Brand

Colace®
Docusate Sodium, 100mg

REGULAR
STRENGTH

Stool Softener
√ Gentle, Effective Relief
√ Cramp & Stimulant-free

150 Capsules

Do not use if imprinted seal under cap is missing or damaged.

Colace is a
registered trademark
of Atlantis Consumer
Healthcare Inc.

A0125

Dist. by: Atlantis Consumer Healthcare Inc., Bridgewater, NJ 08807 USA
Questions? 1-833-288-2684 2025 Atlantis Consumer Healthcare Inc.
PLD-B487B
LB010259

Lot No.:

Exp. Date:

#1 DOCTOR
RECOMMENDED
Stool Softener Brand

Colace®
Docusate Sodium, 100mg

REGULAR
STRENGTH

Stool Softener
√ Gentle & Effective
√ Relieves Constipation
√ Cramp & Stimulant-free

250 Capsules

Do not use if imprinted seal under cap is missing or damaged.

Colace is a
registered
trademark of
Atlantis Consumer
Healthcare Inc.

A0925

Dist. by: Atlantis Consumer Healthcare Inc., Bridgewater, NJ 08807 USA
Questions? 1-833-288-2684 ©2025 Atlantis Consumer Healthcare Inc.

R54023

Lot:
Exp:

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0367618101520	GTIN-13: 0367618101520 EAN-13: 0367618101520 GTIN-12: 367618101520 UPC-A: 367618101520 GTIN storage (14 digits): 00367618101520	colace_250ct.jpg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Docusate sodium	ACTIVE INGREDIENT	F05Q2T2JA0	2
docusate	ACTIVE MOIETY	M7P27195AG	2
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	2

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

Colace
Docusate sodium
docusate
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

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
67618-101	67618-101-10, 67618-101-30, 67618-101-60, 67618-101-01, 67618-101-52, 67618-101-51, 67618-101-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Docusate sodium	F05Q2T2JA0	ACTIB
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

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
17	2026-07-20	daily-update	2026-07-24 05:10:16
16	2026-07-09	daily-update	2026-07-17 21:45:29
15	2026-06-29	monthly-update	2026-07-17 21:37:03
14	2026-06-02	full-release	2026-06-05 00:30:42
13	2025-02-25	full-release	2026-06-01 00:56:11

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 56 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Maximum daily exposure	Match
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CAPSULE / ORAL	13440 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE / ORAL	3487 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CAPSULE / ORAL	13440 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CAPSULE / ORAL	13440 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE / ORAL	16 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
D&C RED NO. 33	D&C RED NO. 33	9DBA0SBB0L	CAPSULE / ORAL	1 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CAPSULE / ORAL	13440 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CAPSULE / ORAL	13440 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE / ORAL	10932 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE / ORAL	1072 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CAPSULE / ORAL	13440 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
D&C RED NO. 33	D&C RED NO. 33	9DBA0SBB0L	CAPSULE / ORAL	1 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE / ORAL	3487 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE / ORAL	16 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CAPSULE / ORAL	13440 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
D&C RED NO. 33	D&C RED NO. 33	9DBA0SBB0L	CAPSULE / ORAL	1 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
D&C RED NO. 33	D&C RED NO. 33	9DBA0SBB0L	CAPSULE / ORAL	1 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE / ORAL	10932 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CAPSULE / ORAL	1111 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CAPSULE / ORAL	1111 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE / ORAL	1072 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE / ORAL	1072 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE / ORAL	3487 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
D&C RED NO. 33	D&C RED NO. 33	9DBA0SBB0L	CAPSULE / ORAL	1 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE / ORAL	10932 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE / ORAL	10932 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CAPSULE / ORAL	1111 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE / ORAL	1072 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE / ORAL	16 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE / ORAL	10932 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE / ORAL	10932 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE / ORAL	1072 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
D&C RED NO. 33	D&C RED NO. 33	9DBA0SBB0L	CAPSULE / ORAL	1 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE / ORAL	16 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CAPSULE / ORAL	1111 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
D&C RED NO. 33	D&C RED NO. 33	9DBA0SBB0L	CAPSULE / ORAL	1 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE / ORAL	3487 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE / ORAL	10932 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE / ORAL	1072 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE / ORAL	10932 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE / ORAL	3487 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE / ORAL	1072 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE / ORAL	16 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CAPSULE / ORAL	1111 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE / ORAL	3487 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE / ORAL	3487 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE / ORAL	16 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CAPSULE / ORAL	1111 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CAPSULE / ORAL	1111 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE / ORAL	16 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CAPSULE / ORAL	1111 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE / ORAL	16 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CAPSULE / ORAL	13440 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE / ORAL	3487 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE / ORAL	1072 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
D&C RED NO. 33	D&C RED NO. 33	9DBA0SBB0L	CAPSULE / ORAL	1 mg	Exact identifier — unii+route+dosage form 8 equally ranked IID candidates

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.	7793fced-e8ee-44e2-b212-dd2a59a5f462	2026-08-04	Warnings	Exact identifier ndc (package): 67618-101-25 ndc (package): 67618-101-60 ndc (package): 67618-101-30 ndc (package): 67618-101-51 ndc (package): 67618-101-01 ndc (package): 67618-101-10 ndc (package): 67618-101-52 ndc (product): 67618-101 ndc11 (package): 67618010152 ndc11 (package): 67618010101 ndc11 (package): 67618010130 ndc11 (package): 67618010125 ndc11 (package): 67618010110 ndc11 (package): 67618010160 ndc11 (package): 67618010151 spl id: 650714ee-2cec-42c9-8631-b3f8ebc7348f spl set id: 7793fced-e8ee-44e2-b212-dd2a59a5f462

Reported adverse events (FAERS/openFDA)#

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

Colace - Atlantis Consumer Healthcare, Inc.