Leader Stool Softener plus Stimulant Laxative

Manufacturer: Cardinal Health
Effective date: 2012-03-05
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: legacy-cache
Hydrated at: 2026-08-02 01:49:34

Label at a glance#

ProductLeader Stool Softener plus Stimulant Laxative

Active ingredientDOCUSATE SODIUM, SENNOSIDES A AND B

Label structure9 sections

Indications and uses

relieves occasional constipation (irregularity) generally produces a bowel movement within 6 to 12hours.

Dosage and administration

Take only by mouth. Doses may be taken as a single daily does 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

Storage and handling

each softgel contains: sodium 6mg VERY LOW SODIUM each tablet contains: calcium 20mg/tablets store at 15 - 30 degrees C (59-86 degrees F), protect from excessive moisture do not use if imprinted safety seal under cap is broken or missing. *This product is not manufactured or distributed by Purdue Products, LP, owner of the registered trademark Peri Colace.

Contacts and useful links#

PhoneLabel contact1-800-200-6313

Websitewww.myleader.com

www.myleader.com

Label contents#

Full prescribing information#

Active Ingredients (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Docusate Sodium 50mg
Sennosides 8.6mg

Purpose

OTC - PURPOSE SECTION

Stool softener
Stimulant Laxative

Uses

INDICATIONS & USAGE SECTION

relieves occasional constipation (irregularity)
generally produces a bowel movement within 6 to 12hours.

Warnings - Do not use

WARNINGS SECTION

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.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

stomach pain
nausea
vomiting
noticed a sudden change in bowel habits that lasts over 2 weeks.

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

If pregnant or breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Take only by mouth. Doses may be taken as a single daily does 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

Other information

STORAGE AND HANDLING SECTION

each softgel contains: sodium 6mg VERY LOW SODIUM
each tablet contains: calcium 20mg/tablets
store at 15 - 30 degrees C (59-86 degrees F), protect from excessive moisture
do not use if imprinted safety seal under cap is broken or missing.
*This product is not manufactured or distributed by Purdue Products, LP, owner of the registered trademark Peri Colace.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, ethanol, FDandC Blue no2 Aluminum Lake, FDandC Red No40 Aluminum Lake, hypromellose, magnesium stearate, *maltodextrin, microcrystalline cellulose, *mineral oil, *Opadry II red, polyethylene glycol (PEG) 400, *pregelatinized starch, *silicon dioxide 50s, sodium benzoate, stearic acid and titanium dioxide. *May also contain.

Questions or comments?

OTC - QUESTIONS SECTION

call toll free:1-800-200-6313

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Comapre to the active ingredient Peri Colace

Leader

Stool Softener plus Stimulant Laxative

Docusate Sodium 50mg
Sennosides, 8.6mg

Relieves of Occasional Constipation
100 Softgels

Distributed by Cardinal Health
Dublin, Ohio 43017
CIN 1382639

www.myleader.com
1-800-200-6313

All Leader Brand Products are 100% satisfaction guaranteed or return to place of purchase for a full refund.

Product Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Stool Softener

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
37205-349-78	2025-04-11	C162847	48780-1	9d75b9d0-ef89-f424-e053-dadaa90a57ce	Leader Stool Softener plus Laxative
37205-349-78	2020-01-31	C162847	48780-1	9d75b9d0-ef89-f424-e053-dadaa90a57ce	Leader Stool Softener plus Laxative

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
37205-349-78	EA - Each	37205-349	5aeb33ae-9ddf-4738-b8c3-e3e4e7657236	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
DOCUSATE SODIUM	ACTIVE INGREDIENT	F05Q2T2JA0	2
SENNOSIDES A AND B	ACTIVE INGREDIENT	1B5FPI42EN	2
DOCUSATE	ACTIVE MOIETY	M7P27195AG	2
SENNOSIDES A AND B	ACTIVE MOIETY	1B5FPI42EN	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	2
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	2
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	2
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	2
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 21 matching rows.

Leader Stool Softener plus Stimulant Laxative
DOCUSATE SODIUM, SENNOSIDES
DOCUSATE SODIUM
DOCUSATE
SENNOSIDES A AND B
CARNAUBA WAX
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
ALCOHOL
FD&C BLUE NO. 2
FD&C RED NO. 40
HYPROMELLOSES
MAGNESIUM STEARATE
MALTODEXTRIN
CELLULOSE, MICROCRYSTALLINE
MINERAL OIL
POLYETHYLENE GLYCOL 400
SODIUM BENZOATE
STEARIC ACID
TITANIUM DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
37205-349	37205-349-78

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DOCUSATE SODIUM	F05Q2T2JA0	ACTIB
SENNOSIDES A AND B	1B5FPI42EN	ACTIB
CARNAUBA WAX	R12CBM0EIZ	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	O7TSZ97GEP	IACT
ALCOHOL	3K9958V90M	IACT
FD&C BLUE NO. 2	L06K8R7DQK	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MALTODEXTRIN	7CVR7L4A2D	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
MINERAL OIL	T5L8T28FGP	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
STEARIC ACID	4ELV7Z65AP	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 8 · 466 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	GUM, CHEWING / BUCCAL		182 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	FILM, EXTENDED RELEASE / TRANSDERMAL	49 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION, EMULSION / INTRAVENOUS		520 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	OINTMENT / TOPICAL		1950 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION / INTRAMUSCULAR		1491 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SUSPENSION/ DROPS / ORAL		1 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL		582 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / DENTAL	19 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, COATED / ORAL		920 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, ORALLY DISINTEGRATING / ORAL		41 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	CAPSULE, DELAYED RELEASE / ORAL		105 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL		736 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	GEL / VAGINAL		1250 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	DIBASIC CALCIUM PHOSPHATE DIHYDRATE	O7TSZ97GEP	TABLET, DELAYED RELEASE / ORAL		2834 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, EXTENDED RELEASE / ORAL		5119 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	GUM, CHEWING / BUCCAL		48 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, EXTENDED RELEASE / ORAL		67 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CAPSULE, EXTENDED RELEASE / ORAL		17 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SOLUTION / ORAL		38 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, DELAYED RELEASE / ORAL		2210 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	POWDER, FOR SUSPENSION / ORAL		160 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, DELAYED RELEASE PELLETS / ORAL	0.02 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE PELLETS / ORAL		24 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SYSTEM / TOPICAL		420 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	POWDER, FOR SOLUTION / ORAL		690 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE / ORAL		16 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GRANULE, FOR SUSPENSION / ORAL		120 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	GEL / TOPICAL		6300 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / BUCCAL	17.5 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	POWDER, FOR SUSPENSION / ORAL		3 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL		6184 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, COATED PELLETS / ORAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	FILM, SOLUBLE / ORAL		19 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE / ORAL	5000 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, CHEWABLE / ORAL		254 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, METERED / RESPIRATORY (INHALATION)		26664 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	GRANULE, FOR SUSPENSION / ORAL	1.7 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SUSPENSION / ORAL	100 mg/5ml		Exact identifier — unii candidate 28 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SOLUTION / ORAL		336 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	FILM / BUCCAL		1 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL		750 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	PASTE, DENTIFRICE / DENTAL	0.4 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	221 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SOLUTION / TOPICAL	0.1 %w/v		Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	PASTE, DENTIFRICE / DENTAL	0.5 %w/w		Exact identifier — unii candidate 35 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	WAFER / ORAL	66 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	POWDER, FOR SUSPENSION / ORAL	11.25 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	FILM, SOLUBLE / BUCCAL		11 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, DELAYED RELEASE / ORAL	3.2 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 27 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, EXTENDED RELEASE / ORAL		450 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUSPENSION / AURICULAR (OTIC)	0.5 %w/v		Exact identifier — unii candidate 30 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / RESPIRATORY (INHALATION)	0.08 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	POWDER, FOR SUSPENSION / ORAL		4441 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, FOR SUSPENSION / ORAL		200 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, DELAYED RELEASE / ORAL		280 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, DELAYED RELEASE / ORAL		79 mg	Exact identifier — unii candidate 27 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
cffa89e6-2188-4af8-83b9-5a28a0819e31			dac2c344-cbf4-45d0-b126-cb5c5987570f	2025-04-09	Warnings	Exact identifier spl set id: dac2c344-cbf4-45d0-b126-cb5c5987570f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.