Stool Softener + Stimulant Laxative

Drug Facts

Composition & Product

Active Ingredients

Docusate (50 mg) Sennosides (8.6 mg)

Inactive Ingredients

Povidone K30 Water Carboxymethylcellulose Sodium Sorbitol Lecithin, Soybean Titanium Dioxide Silicon Dioxide Yellow Wax D&c Red No. 33 Fd&c Red No. 40 Gelatin Glycerin Light Mineral Oil

Identifiers & Packaging

Pill Appearance

Imprint: 584 Shape: capsule Color: red Size: 12 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Completed Since 2019-01-30 Until 2026-05-31

Medication Information

Warnings and Precautions

Warnings

Description

DRUG FACTS

Uses

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

Section 42229-5

DRUG FACTS

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1800-222-1222) right away.

Section 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 may indicate 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

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 53414-9

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

Section 55105-1

Purpose

Stool softener

Stimulant Laxative

Section 55106-9

Active ingredients

(in each softgel)

Docusate sodium 50 mg

Sennosides 8.6 mg

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 of age or over	take 2-4 softgels daily
children 6 to under 12 years of age	take 1-2 softgels daily
children 2 to under 6 years of age	take upto 1 softgel daily
children under 2	ask a doctor

Other Information

each softgel contains: calcium 2 mg and sodium 3 mg
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
Keep tightly closed

Inactive Ingredients

Aerosil, beeswax, FD&C Red No.33, FD&C Red No.40, gelatin, glycerin, light liquid paraffin, povidone (PVP K-30), purified water, sodium carboxymethylcellulose, sorbitol solution, soya lecithin, titanium dioxide

Questions Or Comments?

1-888-333-9792

Principal Display Panel 60 Capsule Bottle Carton

Leader™

NDC 70000-0442-1

Stool

Softener +

Stimulant

Laxative

Docusate Sodium, 50 mg

Sennosides, 8.6 mg

COMPARE TO

COLACE®

2-IN-1

active ingredients*

100% Money

Back Guarantee

60 SOFTGELS

Actual Size

Structured Label Content

Uses

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

Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

DRUG FACTS

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1800-222-1222) right away.

Section 50566-9 (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 may indicate 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)

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 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Stool softener

Stimulant Laxative

Section 55106-9 (55106-9)

Active ingredients

(in each softgel)

Docusate sodium 50 mg

Sennosides 8.6 mg

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 of age or over	take 2-4 softgels daily
children 6 to under 12 years of age	take 1-2 softgels daily
children 2 to under 6 years of age	take upto 1 softgel daily
children under 2	ask a doctor

Other Information (Other information)

each softgel contains: calcium 2 mg and sodium 3 mg
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
Keep tightly closed

Inactive Ingredients (Inactive ingredients)

Aerosil, beeswax, FD&C Red No.33, FD&C Red No.40, gelatin, glycerin, light liquid paraffin, povidone (PVP K-30), purified water, sodium carboxymethylcellulose, sorbitol solution, soya lecithin, titanium dioxide

Questions Or Comments? (Questions or Comments?)

1-888-333-9792

Principal Display Panel 60 Capsule Bottle Carton (PRINCIPAL DISPLAY PANEL - 60 Capsule Bottle Carton)

Leader™

NDC 70000-0442-1

Stool

Softener +

Stimulant

Laxative

Docusate Sodium, 50 mg

Sennosides, 8.6 mg

COMPARE TO

COLACE®

2-IN-1

active ingredients*

100% Money

Back Guarantee

60 SOFTGELS

Actual Size

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "relieves occasional constipation (irregularity) generally produces bowel movement in 6-12 hours", "34071-1": "Warnings", "42229-5": "DRUG FACTS", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1800-222-1222) 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 may indicate 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": "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", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Purpose Stool softener Stimulant Laxative", "55106-9": "Active ingredients (in each softgel) Docusate sodium 50 mg Sennosides 8.6 mg", "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 of age or over take 2-4 softgels daily children 6 to under 12 years of age take 1-2 softgels daily children 2 to under 6 years of age take upto 1 softgel daily children under 2 ask a doctor", "Other information": "each softgel contains: calcium 2 mg and sodium 3 mg store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) Keep tightly closed", "Inactive ingredients": "Aerosil, beeswax, FD&C Red No.33, FD&C Red No.40, gelatin, glycerin, light liquid paraffin, povidone (PVP K-30), purified water, sodium carboxymethylcellulose, sorbitol solution, soya lecithin, titanium dioxide", "Questions or Comments?": "1-888-333-9792", "PRINCIPAL DISPLAY PANEL - 60 Capsule Bottle Carton": "Leader™ NDC 70000-0442-1 Stool Softener + Stimulant Laxative Docusate Sodium, 50 mg Sennosides, 8.6 mg COMPARE TO COLACE® 2-IN-1 active ingredients* 100% Money Back Guarantee 60 SOFTGELS Actual Size"}

Stool Softener + Stimulant Laxative

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information