SENNA- sennosides capsule, gelatin coated

SENNA by

Drug Labeling and Warnings

SENNA 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

Active ingredient (in each softgel)

Sennosides 8.6 mg

Purpose

Laxative

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 directed 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

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.

PREGNANCY OR BREAST FEEDING

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 (1-800-222-1222) 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 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

SPL UNCLASSIFIED SECTION

Drug Facts (continued)

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

QUESTIONS

Questions or comments? 1-888-333-9792

PRINCIPAL DISPLAY PANEL - LEADER™ REGULAR STRNGTH SENNA 60 Softgels Bottle Carton

LEADER 

COMPARE TO
SENOKOT®
REGULAR
STRENGTH
active ingredient*
100% Money
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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.

INGREDIENTS AND APPEARANCE

SENNA 
sennosides capsule, gelatin coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0441
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
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
YELLOW WAX (UNII: 2ZA36H0S2V)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
PARAFFIN (UNII: I9O0E3H2ZE)
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	brown (Opaque)	Score	no score
Shape	CAPSULE (SOFTGEL)	Size	12mm
Flavor		Imprint Code	458
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0441-1	1 in 1 CARTON	12/26/2018
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	12/26/2018

Labeler - Leader™ (097537435)

Registrant - Spirit Pharmaceuticals LLC (179621011)

Establishment
Name	Address	ID/FEI	Business Operations
MEDGEL PRIVATE LTD		677385498	manufacture(70000-0441)