SENNA PLUS- sennosides and docusate sodium tablet

Senna Plus by

Drug Labeling and Warnings

Senna Plus by is a Otc medication manufactured, distributed, or labeled by NCS HealthCare of KY, Inc dba Vangard Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Sennosides from Senna Concentrate 8.6 mg

Sodium Dioctylsulfosuccinate 50 mg

Purpose

Laxetive

Stool Softener

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

if you are now taking mineral oil, unless directed by a doctor

Ask a doctor before use if you have

stomache pain, nausea, vomiting, noticed a sudden change in bowel habits that continues over a period of 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 care 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 over 12 years				2 tablets once a day		4 tablets twice a day
children 6 to under 12 years				1 tablet once a day		2 tablets twice a day
children under 6 years				ask a doctor

Other Information

Store at room temperature, USP

Other ingredients

Croscarmellose Sodium, Dicalcium Phosphate, FD&C Yellow #5 Lake**, FD&C Yellow #6 Lake, Hypromellose, Magnesium Silicate, Magnesium Stearate, Microcrystalline Cellulose, Mineral Oil, Polyethylene Glycol, Sodium Benzoate, Sodium Lauryl Sulfate, Starch, Stearic Acid, Titanium Dioxide and Triacetin.

Questions

Serious Adverse Effects Call: (800) 616-2471

**WARNING: Contains FD&C Yellow #5 Lake (Tartrazine) as a color additive.

*This product is not manufactured or distributed by Purdue Pharma L.P. owner of the registered trademark Senokto-S®.

Distributed by: Major Pharmaceuticals  31778 Enterprise Drive, Livonia, MI 48150, USA

Rev. 04/11 M-29

Principal Display Panel

Senna Plus Tablets

(Standardized senna concentrate equiv. to

8.6mg sennosides and sodium dioctylsulfosuccinate 50mg)

INGREDIENTS AND APPEARANCE

SENNA PLUS 
sennosides and docusate sodium tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0615-5533(NDC: 0904-5512)
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM SILICATE (UNII: 9B9691B2N9)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MINERAL OIL (UNII: T5L8T28FGP)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STARCH, TAPIOCA (UNII: 24SC3U704I)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STEARIC ACID (UNII: 4ELV7Z65AP)
TARTARIC ACID (UNII: W4888I119H)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	ORANGE	Score	no score
Shape	ROUND (bi-convex)	Size	10mm
Flavor		Imprint Code	CPC;490
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0615-5533-31	31 in 1 BLISTER PACK
2	NDC: 0615-5533-39	30 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part334	06/16/2011

Labeler - NCS HealthCare of KY, Inc dba Vangard Labs (050052943)

Establishment
Name	Address	ID/FEI	Business Operations
NCS HealthCare of KY, Inc dba Vangard Labs		050052943	RELABEL(0615-5533) , REPACK(0615-5533)