Colace Clear

Colace Clear
SPL v10
SPL
SPL Set ID a1591da0-a1a9-9583-3cf5-788b8fee3814
Route
ORAL
Published
Effective Date 2026-03-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docusate (50 mg)
Inactive Ingredients
Gelatin, Unspecified Glycerin Polyethylene Glycol 400 Propylene Glycol Sorbitol

Identifiers & Packaging

Pill Appearance
Imprint: CLR;50 Shape: oval Color: brown Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 1900-01-07

Description

Drug Facts


Medication Information

Indications and Usage

Uses

  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours
Dosage Forms and Strengths

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.

Description

Drug Facts

Section 43678-2

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
Section 50565-1

Keep out of reach of  children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9

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
Section 50569-3

Ask a doctor before use if you have

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts over 2 weeks
Section 50570-1

Warnings

Do not use

  • if you are presently taking mineral oil, unless told to do so by a doctor
Section 51727-6

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.

Section 53414-9

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

Section 55105-1
Active ingredient Purpose
(in each soft gel)  
Docusate sodium 50 mg........... Stool softener
Section 55106-9

Drug Facts

Package Label.principal Display Panel

#1 DOCTOR

RECOMMENDED

Stool Softener Brand




Colace

Docusate Sodium, 50mg



CLEAR



Stool Softener

√ Gentle, Effective Relief

√ Dye & Preservative-free

√ Cramp & Stimulant-free



28 Clear Soft Gels

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

√ Non -GMO



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

©2023 Atlantis Consumer Healthcare Inc.

Colace is a registered trademark of Atlantis

Consumer Healthcare Inc.



Lot No.:



Exp. Date:



A0923

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

Do not use if imprinted seal under cap is missing

or damaged. See carton for additional information.



R54010

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.



R54366



Lot No.:



Exp. Date:



A0925

Do not use if imprinted seal under cap is missing

or damaged. See carton for additional information.



R54367


Structured Label Content

Indications and Usage (34067-9)

Uses

  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours
Dosage Forms and Strengths (34069-5)

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.

Section 43678-2 (43678-2)

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
Section 50565-1 (50565-1)

Keep out of reach of  children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

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
Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts over 2 weeks
Section 50570-1 (50570-1)

Warnings

Do not use

  • if you are presently taking mineral oil, unless told to do so by a doctor
Section 51727-6 (51727-6)

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.

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)
Active ingredient Purpose
(in each soft gel)  
Docusate sodium 50 mg........... Stool softener
Section 55106-9 (55106-9)

Drug Facts

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

#1 DOCTOR

RECOMMENDED

Stool Softener Brand




Colace

Docusate Sodium, 50mg



CLEAR



Stool Softener

√ Gentle, Effective Relief

√ Dye & Preservative-free

√ Cramp & Stimulant-free



28 Clear Soft Gels

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

√ Non -GMO



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

©2023 Atlantis Consumer Healthcare Inc.

Colace is a registered trademark of Atlantis

Consumer Healthcare Inc.



Lot No.:



Exp. Date:



A0923

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

Do not use if imprinted seal under cap is missing

or damaged. See carton for additional information.



R54010

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.



R54366



Lot No.:



Exp. Date:



A0925

Do not use if imprinted seal under cap is missing

or damaged. See carton for additional information.



R54367


Advanced Ingredient Data


Raw Label Data

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