SENEXON-S- docusate sodium-sennosides tablet tablet, coated

SENEXON-S by

Drug Labeling and Warnings

SENEXON-S 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 ingredients (in each tablet)

Docusate sodium 50 mg

Sennosides 8.6 mg

Purposes

Stool Softener

Stimulant Laxative 

Uses

relieves occasional constipation

generally produces bowel movement in 6 - 12 hours 

Warnings

Do not use  if you are taking mineral oil     for longer than one week    when abdominal pain, nausea or vomiting are present

ASK DOCTOR

Ask a doctor before use if you have noticed a sudden change in bowel habits that lasts over two weeks

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

STOP USE

Stop use and ask a doctor if   you have rectal bleeding  you fail to have a bowel movement after use of this product. 

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

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

if you do not have a comforable bowel movement by the second day, increase dose by one tablet (do not exceed maximum dosage)

age				starting dosage		maximum dosage
adults and children 12 years and older				2 tablets once daily		4 tablets twice daily
children 5 to under 12 years				1 tablet once daily		2 tablets twice daily
children 2 to under 6 years				1/2 tablet once daily		1 tablet twice daily
children under 2 years				ask a doctor		ask a doctor

Other Information

each tablet contains: calcium 20 mg, sodium 6 mg (LOW SODIUM)

store at 20º - 25ºC (68º - 77ºF) 

Inactive Ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium benzoate, stearic acid, titanium dioxide

Questions or comments?

1-800-645-2158

SPL UNCLASSIFIED SECTION

 Dispense contents with a child-resistant closure in a tight, light-resistant container as defined in the USP.

192R

Distributed by: Rugby Laboratories

31778 Enterprise Drive, Livonia, MI 48150

R-14  Rev. 03/13

Principal Display Panel

INGREDIENTS AND APPEARANCE

SENEXON-S 
docusate sodium-sennosides tablet tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0615-7773(NDC: 0536-4086)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SENNOSIDES A AND B (UNII: 1B5FPI42EN) (SENNOSIDES A AND B - UNII:1B5FPI42EN)	SENNOSIDES A AND B	8.6 mg
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	50 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
SODIUM BENZOATE (UNII: OJ245FE5EU)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	ORANGE	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	TCL081
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0615-7773-31	31 in 1 BLISTER PACK
2	NDC: 0615-7773-39	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	02/09/2006

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(0615-7773) , REPACK(0615-7773)