LEADER REGULAR STRENGTH SENNA LAXATIVE SOFTGEL- sennosides capsule, liquid filled

LEADER Regular Strength Senna Laxative SOFTGEL by

Drug Labeling and Warnings

LEADER Regular Strength Senna Laxative SOFTGEL by is a Otc medication manufactured, distributed, or labeled by Cardinal Health 110, LLC. DBA Leader, SOFTGEL HEALTHCARE PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each softgel)

Sennosides 8.6 mg

Purpose

Laxative

Uses

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

Warnings

Do not use
laxative products for longer than 1 week unless directed by a doctor

Ask a doctor before use if you have
stomach pain nausea vomiting noticed a sudden change in bowel habits that continues over a period of 2 weeks

Stop use and ask a doctor ifyou 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 right away.

Directions

take preferably at bedtime or as directed by a doctor

Age	Starting Dosage	Maximum Dosage
adults and children 12 years of age and 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

Other information

 each softgel contains: calcium 4 mg
 store at room temperature between 20°-25°C (68°-77°F)

Inactive ingredients

black iron oxide, fumaric acid, gelatin, glycerin, lecithin liquid, methyl paraben, purified water, red iron oxide, sorbitol 70% solution, soybean oil, yellow bees wax

Questions or comments?

Call 1-800-200-6313

SPL UNCLASSIFIED SECTION

Standardized Senna Concentrate

Natural Vegetable Laxative Ingredient

COMPARE TO SENOKOT ®REGULAR STRENGTH active ingredient*

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

CardinalHealth ™

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017

www.myleader.com
1-800-200-6313
Essential to Care™ since 1979

Product of India

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

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

Overnight, gentle laxative

*This product is not manufactured or distributed by Atlantis Consumer Healthcare Inc., owner of the registered trademark Senokot®.
©2024 Cardinal Health. CARDINAL HEALTH, the Cardinal Health LOGO, ESSENTIAL TO CARE, LEADER, and the LEADER LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners.

Packaging

INGREDIENTS AND APPEARANCE

LEADER REGULAR STRENGTH SENNA LAXATIVE SOFTGEL 
sennosides capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0686
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX)	SENNOSIDES	8.6 mg

Inactive Ingredients
Ingredient Name	Strength
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FUMARIC ACID (UNII: 88XHZ13131)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
SOYBEAN LECITHIN (UNII: 1DI56QDM62)
METHYLPARABEN (UNII: A2I8C7HI9T)
WATER (UNII: 059QF0KO0R)
FERRIC OXIDE RED (UNII: 1K09F3G675)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
SOYBEAN OIL (UNII: 241ATL177A)
YELLOW WAX (UNII: 2ZA36H0S2V)

Product Characteristics
Color	brown	Score	no score
Shape	OVAL	Size	10mm
Flavor		Imprint Code	901
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0686-1	1 in 1 CARTON	07/16/2024	07/31/2025
1		60 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	07/16/2024

Labeler - Cardinal Health 110, LLC. DBA Leader (063997360)

Establishment
Name	Address	ID/FEI	Business Operations
SOFTGEL HEALTHCARE PRIVATE LIMITED		675584180	manufacture(70000-0686)