Colace

Drug Facts

Composition & Product

Active Ingredients

Docusate (50 mg) Sennosides (8.6 mg)

Inactive Ingredients

Microcrystalline Cellulose 102 Mineral Oil Polyethylene Glycol, Unspecified Sodium Benzoate Sodium Lauryl Sulfate Starch, Corn Stearic Acid Talc Titanium Dioxide Triacetin Croscarmellose Sodium Anhydrous Dibasic Calcium Phosphate Fd&c Blue No. 1 Fd&c Red No. 40 Fd&c Yellow No. 6 Hypromellose, Unspecified Magnesium Stearate Maltodextrin

Identifiers & Packaging

Pill Appearance

Imprint: P;054 Shape: round Color: red Size: 10 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 1957-02-08

Medication Information

Indications and Usage

Uses

relieves occasional constipation (irregularity)
generally produces bowel movement in 6 to 12 hours

Dosage and Administration

Directions

Take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses.

adults and children 12 years and over	take 2-4 tablets daily
children 6 to under 12 years of age	take 1-2 tablets daily
children 2 to under 6 years of age	take up to 1 tablet daily
children under 2	ask a doctor

Dosage Forms and Strengths

Other information

each tablet contains: calcium 7 mg, sodium 4 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 Active ingredient Purpose Docusate sodium 50 mg Stool softener Sennosides 8.6 mg Stimulant laxative

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 ifyou have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.

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

laxative products for longer than 1 week unless told to do so by a doctor
if you are presently taking mineral oil, unless told to do so by a doctor

Section 51727-6

Inactive ingredients

croscarmellose sodium, dicalcium phosphate, FD&C Blue #1 Lake, FD&C Red #40 Lake, FD&C Yellow #6 Lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, polyethylene glycol, sodium benzoate, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide, triacetin.

Dist. by: Atlantis Consumer Healthcare inc.

Bridgewater, NJ 08801 USA

Questions? 1-833-286-2684

©2023 Atlantis Consumer Healthcare inc.

Colace is a registered trademark of Atlantis

Consumer Healthcare Inc.

A1023

R52504

Section 53414-9

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

Section 55106-9

Drug Facts

Active ingredient	Purpose
Docusate sodium 50 mg	Stool softener
Sennosides 8.6 mg	Stimulant laxative

Package Label.principal Display Panel

#1

DOCTOR

RECOMMENDED

Stool Softener Brand

Colace®

Docusate Sodium, 50 mg

Sennosides 8.6 mg

2-IN-1

Stool Softener +

Stimulant Laxative

√ Gentle, Effective, & Dependable

√ Constipation Relief in 6 `12 hours

10Tablets

Colace® 2-IN-1 Tablets

Docusate Sodium

Sennosides

Dist. by: Atlantis Consumer

Healthcare Inc.

LOT XXXXXX

EXP YYYY-MM

#1

DOCTOR

RECOMMENDED

Stool Softener Brand

Colace®

Docusate Sodium, 50 mg

Sennosides 8.6 mg

2-IN-1

Stool Softener +

Stimulant Laxative

√ Gentle, Effective, & Dependable

√ Constipation Relief in 6 `12 hours

30Tablets

Retain this carton for

Important information

Dist. by: Atlantis Consumer Healthcare inc.

Bridgewater, NJ 08801 USA

Questions?1-833-286-2684

©2023 Atlantis Consumer Healthcare inc.

Colace is a registered trademark of Atlantis

Consumer Healthcare Inc.

A1023

R52506

Colace®

Docusate Sodium

Sennosides

2-IN-1

Stool Softener +

Stimulant Laxative

30Tablets

Do not use if imprinted seal under cap

is missing or damaged.

See carton for additional information

Dist. by: Atlantis Consumer Healthcare inc.

Bridgewater, NJ 08801 USA

Questions?1-833-286-2684

©2023 Atlantis Consumer Healthcare inc.

Colace is a registered trademark of Atlantis

Consumer Healthcare Inc.

A1023

R52507

#1

DOCTOR

RECOMMENDED

Stool Softener Brand

Colace®

Docusate Sodium, 50 mg

Sennosides 8.6 mg

2-IN-1

Stool Softener +

Stimulant Laxative

√ Gentle, Effective, & Dependable

√ Constipation Relief in 6 `12 hours

Retain this carton for

Important information

For added savings, visit:

colacecapsules.com

Dist. by: Atlantis Consumer Healthcare inc.

Bridgewater, NJ 08801 USA

Questions? 1-833-286-2684

©2023 Atlantis Consumer Healthcare inc.

Colace is a registered trademark of Atlantis

Consumer Healthcare Inc.

A1023

R52508

60Tablets

A1023

R52507

Colace®

Docusate Sodium

Sennosides

2-IN-1

Stool Softener +

Stimulant Laxative

60Tablets

Do not use if imprinted seal under cap

is missing or damaged.

See carton for additional information

Dist. by: Atlantis Consumer Healthcare inc.

Bridgewater, NJ 08801 USA

Questions?1-833-286-2684

©2023 Atlantis Consumer Healthcare inc.

Colace is a registered trademark of Atlantis

Consumer Healthcare Inc.

LOT:

EXP:

A1023

R52509

Structured Label Content

Indications and Usage (34067-9)

Uses

relieves occasional constipation (irregularity)
generally produces bowel movement in 6 to 12 hours

Dosage and Administration (34068-7)

Directions

Take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses.

adults and children 12 years and over	take 2-4 tablets daily
children 6 to under 12 years of age	take 1-2 tablets daily
children 2 to under 6 years of age	take up to 1 tablet daily
children under 2	ask a doctor

Dosage Forms and Strengths (34069-5)

Other information

each tablet contains: calcium 7 mg, sodium 4 mg VERY LOW SODIUM
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F).

Keep tightly closed..

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 ifyou have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.

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

laxative products for longer than 1 week unless told to do so by a doctor
if you are presently taking mineral oil, unless told to do so by a doctor

Section 51727-6 (51727-6)

Inactive ingredients

croscarmellose sodium, dicalcium phosphate, FD&C Blue #1 Lake, FD&C Red #40 Lake, FD&C Yellow #6 Lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, polyethylene glycol, sodium benzoate, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide, triacetin.

Dist. by: Atlantis Consumer Healthcare inc.

Bridgewater, NJ 08801 USA

Questions? 1-833-286-2684

©2023 Atlantis Consumer Healthcare inc.

Colace is a registered trademark of Atlantis

Consumer Healthcare Inc.

A1023

R52504

Section 53414-9 (53414-9)

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

Section 55106-9 (55106-9)

Drug Facts

Active ingredient	Purpose
Docusate sodium 50 mg	Stool softener
Sennosides 8.6 mg	Stimulant laxative

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

#1

DOCTOR

RECOMMENDED

Stool Softener Brand

Colace®

Docusate Sodium, 50 mg

Sennosides 8.6 mg

2-IN-1

Stool Softener +

Stimulant Laxative

√ Gentle, Effective, & Dependable

√ Constipation Relief in 6 `12 hours

10Tablets

Colace® 2-IN-1 Tablets

Docusate Sodium

Sennosides

Dist. by: Atlantis Consumer

Healthcare Inc.

LOT XXXXXX

EXP YYYY-MM

#1

DOCTOR

RECOMMENDED

Stool Softener Brand

Colace®

Docusate Sodium, 50 mg

Sennosides 8.6 mg

2-IN-1

Stool Softener +

Stimulant Laxative

√ Gentle, Effective, & Dependable

√ Constipation Relief in 6 `12 hours

30Tablets

Retain this carton for

Important information

Dist. by: Atlantis Consumer Healthcare inc.

Bridgewater, NJ 08801 USA

Questions?1-833-286-2684

©2023 Atlantis Consumer Healthcare inc.

Colace is a registered trademark of Atlantis

Consumer Healthcare Inc.

A1023

R52506

Colace®

Docusate Sodium

Sennosides

2-IN-1

Stool Softener +

Stimulant Laxative

30Tablets

Do not use if imprinted seal under cap

is missing or damaged.

See carton for additional information

Dist. by: Atlantis Consumer Healthcare inc.

Bridgewater, NJ 08801 USA

Questions?1-833-286-2684

©2023 Atlantis Consumer Healthcare inc.

Colace is a registered trademark of Atlantis

Consumer Healthcare Inc.

A1023

R52507

#1

DOCTOR

RECOMMENDED

Stool Softener Brand

Colace®

Docusate Sodium, 50 mg

Sennosides 8.6 mg

2-IN-1

Stool Softener +

Stimulant Laxative

√ Gentle, Effective, & Dependable

√ Constipation Relief in 6 `12 hours

Retain this carton for

Important information

For added savings, visit:

colacecapsules.com

Dist. by: Atlantis Consumer Healthcare inc.

Bridgewater, NJ 08801 USA

Questions? 1-833-286-2684

©2023 Atlantis Consumer Healthcare inc.

Colace is a registered trademark of Atlantis

Consumer Healthcare Inc.

A1023

R52508

60Tablets

A1023

R52507

Colace®

Docusate Sodium

Sennosides

2-IN-1

Stool Softener +

Stimulant Laxative

60Tablets

Do not use if imprinted seal under cap

is missing or damaged.

See carton for additional information

Dist. by: Atlantis Consumer Healthcare inc.

Bridgewater, NJ 08801 USA

Questions?1-833-286-2684

©2023 Atlantis Consumer Healthcare inc.

Colace is a registered trademark of Atlantis

Consumer Healthcare Inc.

LOT:

EXP:

A1023

R52509

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "Uses relieves occasional constipation (irregularity) generally produces bowel movement in 6 to 12 hours", "34068-7": "Directions Take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses. adults and children 12 years and over take 2-4 tablets daily children 6 to under 12 years of age take 1-2 tablets daily children 2 to under 6 years of age take up to 1 tablet daily children under 2 ask a doctor", "34069-5": "Other information each tablet contains: calcium 7 mg, sodium 4 mg VERY LOW SODIUM store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F). Keep tightly closed..", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "50566-9": "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.", "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", "50570-1": "Warnings Do not use laxative products for longer than 1 week unless told to do so by a doctor if you are presently taking mineral oil, unless told to do so by a doctor", "51727-6": "Inactive ingredients croscarmellose sodium, dicalcium phosphate, FD&C Blue #1 Lake, FD&C Red #40 Lake, FD&C Yellow #6 Lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, polyethylene glycol, sodium benzoate, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide, triacetin. Dist. by: Atlantis Consumer Healthcare inc. Bridgewater, NJ 08801 USA Questions? 1-833-286-2684 ©2023 Atlantis Consumer Healthcare inc. Colace is a registered trademark of Atlantis Consumer Healthcare Inc. A1023 R52504", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55106-9": "Drug Facts Active ingredient Purpose Docusate sodium 50 mg Stool softener Sennosides 8.6 mg Stimulant laxative", "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL": "#1 DOCTOR RECOMMENDED Stool Softener Brand Colace® Docusate Sodium, 50 mg Sennosides 8.6 mg 2-IN-1 Stool Softener + Stimulant Laxative √ Gentle, Effective, & Dependable √ Constipation Relief in 6 `12 hours 10 Tablets Colace® 2-IN-1 Tablets Docusate Sodium Sennosides Dist. by: Atlantis Consumer Healthcare Inc. LOT XXXXXX EXP YYYY-MM #1 DOCTOR RECOMMENDED Stool Softener Brand Colace® Docusate Sodium, 50 mg Sennosides 8.6 mg 2-IN-1 Stool Softener + Stimulant Laxative √ Gentle, Effective, & Dependable √ Constipation Relief in 6 `12 hours 30 Tablets Retain this carton for Important information Dist. by: Atlantis Consumer Healthcare inc. Bridgewater, NJ 08801 USA Questions? 1-833-286-2684 ©2023 Atlantis Consumer Healthcare inc. Colace is a registered trademark of Atlantis Consumer Healthcare Inc. A1023 R52506 Colace® Docusate Sodium Sennosides 2-IN-1 Stool Softener + Stimulant Laxative 30 Tablets Do not use if imprinted seal under cap is missing or damaged. See carton for additional information Dist. by: Atlantis Consumer Healthcare inc. Bridgewater, NJ 08801 USA Questions? 1-833-286-2684 ©2023 Atlantis Consumer Healthcare inc. Colace is a registered trademark of Atlantis Consumer Healthcare Inc. A1023 R52507 #1 DOCTOR RECOMMENDED Stool Softener Brand Colace® Docusate Sodium, 50 mg Sennosides 8.6 mg 2-IN-1 Stool Softener + Stimulant Laxative √ Gentle, Effective, & Dependable √ Constipation Relief in 6 `12 hours Retain this carton for Important information For added savings, visit: colacecapsules.com Dist. by: Atlantis Consumer Healthcare inc. Bridgewater, NJ 08801 USA Questions? 1-833-286-2684 ©2023 Atlantis Consumer Healthcare inc. Colace is a registered trademark of Atlantis Consumer Healthcare Inc. A1023 R52508 60 Tablets A1023 R52507 Colace® Docusate Sodium Sennosides 2-IN-1 Stool Softener + Stimulant Laxative 60 Tablets Do not use if imprinted seal under cap is missing or damaged. See carton for additional information Dist. by: Atlantis Consumer Healthcare inc. Bridgewater, NJ 08801 USA Questions? 1-833-286-2684 ©2023 Atlantis Consumer Healthcare inc. Colace is a registered trademark of Atlantis Consumer Healthcare Inc. LOT: EXP: A1023 R52509"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information