SENNA PLUS- docusate sodium, 50 mg sennosides, 8.6 mg capsule, gelatin coated

Senna Plus by

Drug Labeling and Warnings

Senna Plus 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

Active ingredients                                      Purpose
(in each softgel)
Docusate sodium 50 mg..............................Stool softener
Sennosides 8.6 mg................................................Laxative

Uses

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

Warnings

Do not use

if you are now taking mineral oil, unless directed by a doctor
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 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 (1-800-222-1222) right away.

Directions

take preferably at bedtime or as directed by a doctor

Age	Starting dose	Maximum Dosage
adults and children 12 years of age or older	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 2 mg and sodium 3 mg
■ store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

Inactive ingredients

FD&C yellow #6, gelatin, glycerin, polyethylene glycol-400, povidone (PVP K-30), propylene
glycol, purified water, sorbitol, titanium dioxide

QUESTIONS

Questions or comments?1-888-333-9792

PRINCIPAL DISPLAY PANEL - 60 Softgels Bottle Carton

NDC: 70000-0445-1
Senna Plus
Docusate Sodium, 50 mg | Sennosides, 8.6 mg
Stool Softener | Laxative
COMPARE TO
SENOKOT-S¬
active ingredients*
Dual Action
Standardized Senna Concentrate
60 SOFTGELS Actual Size
100% Money
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INGREDIENTS AND APPEARANCE

SENNA PLUS 
docusate sodium, 50 mg sennosides, 8.6 mg capsule, gelatin coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0445
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE K30 (UNII: U725QWY32X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	orange (Opaque)	Score	no score
Shape	CAPSULE (Softgel)	Size	6mm
Flavor		Imprint Code	S62
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0445-1	1 in 1 CARTON	01/15/2019
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	01/15/2019

Labeler - Leader (097537435)

Registrant - Spirit Pharmaceuticals LLC (179621011)

Establishment
Name	Address	ID/FEI	Business Operations
MEDGEL PRIVATE LTD		677385498	manufacture(70000-0445)