DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Docusate (100 mg)

Inactive Ingredients

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

Identifiers & Packaging

Pill Appearance

Imprint: RPC;053 Shape: oval Color: red Color: white Size: 12 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 1997-01-30

Medication Information

Indications and Usage

Uses

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

Description

Drug Facts

Colace 100 mg

Section 43685-7

Warnings

Do not use

if you are presently taking mineral oil, unless told todo so by a doctor

Section 44425-7

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.

Section 50568-5

Ask a doctor before use if you have

stomach pain
nausea
vomiting
noticed a sudden change in bowel habits that lasts over2 weeks

Section 50570-1

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 51727-6

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

Section 51945-4

#1 DOCTOR

RECOMMENDED

Stool Softener Brand

Colace

Docusate Sodium, 100mg

REGULAR

STRENGTH

Stool Softener

√ Gentle, Effective Relief

√ Cramp & Stimulant-free

100 Capsules

#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:

Section 53414-9

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

Section 55105-1

Purpose

Stool softener

Section 55106-9

Active ingredient (in each capsule):

Docusate sodium 100 mg

Structured Label Content

Indications and Usage (34067-9)

Uses

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

Description (34089-3)

Drug Facts

Colace 100 mg

Section 43685-7 (43685-7)

Warnings

Do not use

if you are presently taking mineral oil, unless told todo so by a doctor

Section 44425-7 (44425-7)

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.

Section 50568-5 (50568-5)

Ask a doctor before use if you have

stomach pain
nausea
vomiting
noticed a sudden change in bowel habits that lasts over2 weeks

Section 50570-1 (50570-1)

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 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

#1 DOCTOR

RECOMMENDED

Stool Softener Brand

Colace

Docusate Sodium, 100mg

REGULAR

STRENGTH

Stool Softener

√ Gentle, Effective Relief

√ Cramp & Stimulant-free

100 Capsules

#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:

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Stool softener

Section 55106-9 (55106-9)

Active ingredient (in each capsule):

Docusate sodium 100 mg

Advanced Ingredient Data

[{"name": "docusate", "unii": "M7P27195AG", "classCode": "ACTIB", "strengthNumerator": "100", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "D&C RED NO. 33", "unii": "9DBA0SBB0L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 6", "unii": "H77VEI93A8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours", "34089-3": "Drug Facts Colace 100 mg", "43685-7": "Warnings Do not use if you are presently taking mineral oil, unless told todo so by a doctor", "44425-7": "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.", "50568-5": "Ask a doctor before use if you have stomach pain nausea vomiting noticed a sudden change in bowel habits that lasts over2 weeks", "50570-1": "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", "51727-6": "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", "51945-4": "#1 DOCTOR RECOMMENDED Stool Softener Brand Colace Docusate Sodium, 100mg REGULAR STRENGTH Stool Softener √ Gentle, Effective Relief √ Cramp & Stimulant-free 100 Capsules #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:", "53414-9": "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", "55105-1": "Purpose Stool softener", "55106-9": "Active ingredient (in each capsule): Docusate sodium 100 mg"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information