COLACE- docusate sodium capsule 
Atlantis Consumer Healthcare, Inc.

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Drug Facts

Colace 100 mg

Active ingredient (in each capsule):

Docusate sodium 100 mg

Purpose

Stool softener

Uses

Warnings

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

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 overtake 1-3 capsules daily
children 2 to under 12 yearsof agetake 1 capsules daily
children under 2 yearsask a doctor

Otherinformation

Keep tightly closed.

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

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

30 Carton

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

30 Label

#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

60 Carton

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

60 Label

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:

100 Carton

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:

100 ct label

#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:

150 count

#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:

250 ct
COLACE 
docusate sodium capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67618-101
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Docusate sodium (UNII: F05Q2T2JA0) (docusate - UNII:M7P27195AG) Docusate sodium100 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITOL (UNII: 506T60A25R)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorRED, WHITEScoreno score
ShapeOVALSize12mm
FlavorImprint Code RPC;053
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67618-101-102 in 1 CARTON01/30/1997
15 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:67618-101-301 in 1 CARTON01/30/1997
230 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:67618-101-601 in 1 CARTON01/30/1997
360 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4NDC:67618-101-011 in 1 CARTON01/17/2022
4100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
5NDC:67618-101-52250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/30/1997
6NDC:67618-101-51150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/28/2025
7NDC:67618-101-25250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/27/2026
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00701/30/1997
Labeler - Atlantis Consumer Healthcare, Inc. (118983925)
Registrant - Atlantis Consumer Healthcare, Inc. (118983925)

Revised: 7/2026
Document Id: 012d9494-3fcd-48db-a9a5-7c4bc577b311
Set id: 7793fced-e8ee-44e2-b212-dd2a59a5f462
Version: 16
Effective Time: 20260709
 
Atlantis Consumer Healthcare, Inc.