STOOL SOFTENER AND STIMULANT LAXATIVE- docusate sodium and sennosides capsule, gelatin coated

STOOL SOFTENER AND STIMULANT LAXATIVE by

Drug Labeling and Warnings

STOOL SOFTENER AND STIMULANT LAXATIVE by is a Otc medication manufactured, distributed, or labeled by Cardinal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS

PURPOSE

Purpose
Stool softener
Stimulant Laxative

ACTIVE INGREDIENT

Active ingredients
(in each softgel) 
Docusate sodium 50 mg
Sennosides 8.6 mg

SPL UNCLASSIFIED SECTION

Uses

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

WARNINGS

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

Ask a doctor before use if you have

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

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.

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

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

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

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Purdue
Products L.P., owner of the registered trademark Colace® 2-IN-1.

© 2019 Cardinal Health. All Rights Reserved. CARDINAL HEALTH,
the Cardinal Health LOGO, LEADER, and the Leader LOGO are
trademarks or registered trademarks of Cardinal Health. All other
marks are the property of their respective owners.

DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017
www.myleader.com 1-800-200-6313
Made in India

All LEADER™ Brand Products Have A
Return to place of purchase if not satisfied.
100% Money Back Guarantee

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY
SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE
WARNINGS AND PRODUCT INFORMATION

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

INGREDIENTS AND APPEARANCE

STOOL SOFTENER AND STIMULANT LAXATIVE 
docusate sodium and sennosides capsule, gelatin coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0442
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	50 mg
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX)	SENNOSIDES	8.6 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
YELLOW WAX (UNII: 2ZA36H0S2V)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
POVIDONE K30 (UNII: U725QWY32X)
WATER (UNII: 059QF0KO0R)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SORBITOL (UNII: 506T60A25R)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	red (OPAQUE)	Score	no score
Shape	CAPSULE (SOFTGEL)	Size	12mm
Flavor		Imprint Code	584
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0442-1	1 in 1 CARTON	01/30/2019
1		60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	01/30/2019

Labeler - Leader (097537435)

Registrant - SPIRIT PHARMACEUTICALS LLC (179621011)

Establishment
Name	Address	ID/FEI	Business Operations
MEDGEL PRIVATE LIMITED		677385498	manufacture(70000-0442)