Leader™ Regular Strength Senna 60ct

Drug Facts

Composition & Product

Active Ingredients

Sennosides (8.6 mg)

Inactive Ingredients

Silica Dimethyl Silylate Yellow Wax Fd&c Blue No. 1 Fd&c Red No. 40 Fd&c Yellow No. 6 Gelatin Glycerin Paraffin Povidone K30 Water Carboxymethylcellulose Sodium Sorbitol Lecithin, Soybean Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: 458 Shape: capsule Color: brown Size: 12 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Completed Since 2018-12-26 Until 2026-05-31

Medication Information

Warnings and Precautions

Warnings

Purpose

Laxative

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 (1-800-222-1222) 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 53413-1

Questions or comments? 1-888-333-9792

Section 53414-9

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

Directions

■ take preferably at bedtime or as directed by a doctor

Age	Starting Dosage	Maximum Dosage
adults and children 12 years of age or over	2 softgels once a day	4 softgels twice a day
children 6 to under 12 years	1 softgel once a day	2 softgels twice a day
children under 6 years of age	ask a doctor	ask a doctor

Do Not Use

■ laxative products for longer than 1 week, unless directed by a doctor

Other Information

■ each softgel contains: calcium 1 mg and sodium less than 1 mg

■ store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

Inactive Ingredients

aerosil, beeswax, FD&C Blue No. 1, FD&C Red No.40, FD&C Yellow No. 6, gelatin, glycerin,

light liquid paraffin, povidone (PVP K-30), purified water, sodium carboxymethyl cellulose,

sorbitol solution, soya lecithin, titanium dioxide

Active Ingredient (in Each Softgel)

Sennosides 8.6 mg

Ask A Doctor Before Use If You Have

■ stomach pain ■ nausea ■ vomiting

■ noticed a sudden change in bowel habits that lasts over 2 weeks

Principal Display Panel Leader™ Regular Strngth Senna 60 Softgels Bottle Carton

LEADER

COMPARE TO

SENOKOT®

REGULAR

STRENGTH

active ingredient*

100% Money

Back Guarantee

NDC 70000-0441-1

Regular Strength

Senna

Sennosides, 8.6 mg | Laxative

Standardized

Senna Concentrate

Natural Vegetable Laxative Ingredient

60 SOFTGELS

Actual Size

*This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Senokot® Regular Strength.

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 (1-800-222-1222) 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 53413-1 (53413-1)

Questions or comments? 1-888-333-9792

Section 53414-9 (53414-9)

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

Purpose

Laxative

Directions

■ take preferably at bedtime or as directed by a doctor

Age	Starting Dosage	Maximum Dosage
adults and children 12 years of age or over	2 softgels once a day	4 softgels twice a day
children 6 to under 12 years	1 softgel once a day	2 softgels twice a day
children under 6 years of age	ask a doctor	ask a doctor

Do Not Use (Do not use)

■ laxative products for longer than 1 week, unless directed by a doctor

Other Information (Other information)

■ each softgel contains: calcium 1 mg and sodium less than 1 mg

■ store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

Inactive Ingredients (Inactive ingredients)

aerosil, beeswax, FD&C Blue No. 1, FD&C Red No.40, FD&C Yellow No. 6, gelatin, glycerin,

light liquid paraffin, povidone (PVP K-30), purified water, sodium carboxymethyl cellulose,

sorbitol solution, soya lecithin, titanium dioxide

Active Ingredient (in Each Softgel) (Active ingredient (in each softgel))

Sennosides 8.6 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

■ stomach pain ■ nausea ■ vomiting

■ noticed a sudden change in bowel habits that lasts over 2 weeks

Principal Display Panel Leader™ Regular Strngth Senna 60 Softgels Bottle Carton (PRINCIPAL DISPLAY PANEL - LEADER™ REGULAR STRNGTH SENNA 60 Softgels Bottle Carton)

LEADER

COMPARE TO

SENOKOT®

REGULAR

STRENGTH

active ingredient*

100% Money

Back Guarantee

NDC 70000-0441-1

Regular Strength

Senna

Sennosides, 8.6 mg | Laxative

Standardized

Senna Concentrate

Natural Vegetable Laxative Ingredient

60 SOFTGELS

Actual Size

*This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Senokot® Regular Strength.

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 (1-800-222-1222) 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.", "53413-1": "Questions or comments? 1-888-333-9792", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purpose": "Laxative", "Directions": "■ take preferably at bedtime or as directed by a doctor Age Starting Dosage Maximum Dosage adults and children 12 years of age or over 2 softgels once a day 4 softgels twice a day children 6 to under 12 years 1 softgel once a day 2 softgels twice a day children under 6 years of age ask a doctor ask a doctor ", "Do not use": "■ laxative products for longer than 1 week, unless directed by a doctor", "Other information": "■ each softgel contains: calcium 1 mg and sodium less than 1 mg ■ store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)", "Inactive ingredients": "aerosil, beeswax, FD&C Blue No. 1, FD&C Red No.40, FD&C Yellow No. 6, gelatin, glycerin, light liquid paraffin, povidone (PVP K-30), purified water, sodium carboxymethyl cellulose, sorbitol solution, soya lecithin, titanium dioxide", "Active ingredient (in each softgel)": "Sennosides 8.6 mg", "Ask a doctor before use if you have": "■ stomach pain ■ nausea ■ vomiting ■ noticed a sudden change in bowel habits that lasts over 2 weeks", "PRINCIPAL DISPLAY PANEL - LEADER™ REGULAR STRNGTH SENNA 60 Softgels Bottle Carton": "LEADER COMPARE TO SENOKOT® REGULAR STRENGTH active ingredient* 100% Money Back Guarantee NDC 70000-0441-1 Regular Strength Senna Sennosides, 8.6 mg | Laxative Standardized Senna Concentrate Natural Vegetable Laxative Ingredient 60 SOFTGELS Actual Size *This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Senokot® Regular Strength."}

Leader™ Regular Strength Senna 60ct

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information