SENNA PLUS- sennosides and docusate sodium tablet
Cardinal Health

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Active ingredient (in each tablet)

Docusate Sodium 50 mg
Sennosides 8.6 mg

Purpose

Stool softener

Laxative

Uses

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

Warnings

Do not use for more than 1 week unless directed by a doctor

Ask a doctor before use if you -have abdominal pain, nausea or vomiting -are taking mineral oil -have noticed a sudden change in bowel habits that lasts over 2 weeks

Stop use and ask a doctor if -you have no bowel movement within 12 hours -you have rectal bleeding. these could signs of 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

• do not exceed 8 tablets in 24 hours

Age	Starting Dose	Maximum Dose
adults and children 12 years of age and older	2 tablets once a day preferably at bedtime; increase as needed, or as directed by a doctor	4 tablets in the morning and 4 tablets at bedtime
children under 12 years	ask a doctor

Other information

• each tablet contains: calcium 7 mg

• store at room temperature

Inactive ingredients

cellulose, croscarmellose sodium, dicalcium phosphate, FD & C yellow #6, hypromellose, magnesium stearate, PEG, sodium benzoate, stearic acid, titanium dioxide. May also contain D & C yellow #10, FD&C Yellow #5 (tartrazine), magnesium silicate, mineral oil, silica, sodium lauryl sulfate, starch, triacetin, wax

Generic Section

COMPARE TO ACTIVE INGREDIENTS IN SENOKOT-S ®*

*This product is not manufactured or distributed by the owner of the registered trademark Senokot-S®.

Distributed By: Geri-Care Pharmaceuticals Corp.

1650 63rd Street, Brooklyn, NY 11204

Repackaged By:
Cardinal Health

Zanesville, OH 43701

REV 0613

IT49094871213

Principal Display Panel

Senna Plus Tablets

Principal Display Panel

Senna Plus Tablets

Qty 30

SENNA PLUS
sennosides and docusate sodium tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55154-1877(NDC:57896-455)
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SODIUM BENZOATE (UNII: OJ245FE5EU)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
MAGNESIUM SILICATE (UNII: 9B9691B2N9)
MINERAL OIL (UNII: T5L8T28FGP)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STARCH, CORN (UNII: O8232NY3SJ)
TRIACETIN (UNII: XHX3C3X673)
WHITE WAX (UNII: 7G1J5DA97F)

Product Characteristics
Color	ORANGE	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	TCL;081
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55154-1877-9	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	01/01/2000	01/15/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	01/01/2000	01/15/2016

Labeler - Cardinal Health (188557102)

Registrant - Geri-Care Pharmaceutical Corp (611196254)

Name	Address	ID/FEI	Business Operations
Establishment
Cardinal Health		188557102	REPACK(55154-1877)

Revised: 9/2017

Document Id: 72e2893c-d308-4f42-a6b4-c5209a37a692

Set id: 2003456b-3cf7-4c36-9dbf-ebf6d8f21816

Version: 2

Effective Time: 20170922

Cardinal Health