FDA.reportPublic FDA data

SENEXON-S

Manufacturer
NCS HealthCare of KY, Inc dba Vangard Labs
Effective date
2017-01-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:34:32

Label at a glance#

ProductSENEXON-S
Active ingredientDOCUSATE SODIUM, SENNOSIDES A AND B
Label structure14 sections

Indications and uses

relieves occasional constipation generally produces bowel movement in  6-12 hours

Dosage and administration

take preferably at bedtime or as directed by a doctor if you do not have a comfortable bowel movement by the second day, increase dose by one tablet (do not exceed maxiumum dosage) age starting dosage maximum dosage adults and children 12 years and older 2 tablets once daily 4 tablets twice daily children 6 to under 12 years 1 tablet once daily 2 tablets twice daily children 2 to under 6 years 1/2 tablet once dail...

Label contents#

Full prescribing information#

Active ingredients (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Docusate sodium 50 mg

Sennosides 8.6 mg

Purposes

OTC - PURPOSE SECTION

Stool Softener

Stimulant Laxative 

Uses

INDICATIONS & USAGE SECTION

  • relieves occasional constipation
  • generally produces bowel movement in  6-12 hours

Warnings

WARNINGS SECTION

Do not use

  • if you are taking mineral oil
  • for longer than one week
  • when abdominal pain, nausea or vomiting are present

Ask a doctor before use if you

OTC - ASK DOCTOR SECTION

have a sudden change in bowel habits that lasts over two weeks

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

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 and ask a doctor if

OTC - STOP USE SECTION

  • you fail to have a bowel movement after use of this product
  • you have rectal bleeding  

These may indicate a serious condition.

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take preferably at bedtime or as directed by a doctor
  • if you do not have a comfortable bowel movement by the second day, increase dose by one tablet (do not exceed maxiumum dosage)
agestarting dosagemaximum dosage
adults and children 12 years and older2 tablets once daily4 tablets twice daily
children 6 to under 12 years1 tablet once daily2 tablets twice daily
children 2 to under 6 years1/2 tablet once daily1 tablet twice daily
children under 2 yearsask a doctorask a doctor

Other information

OTHER SAFETY INFORMATION

  • each tablet contains: calcium 20mg, sodium 6 mg (LOW SODIUM)
  • store at 20º - 25ºC (68º - 77ºF)

*Rugby Laboratories is not affiliated with the owner of the registered trademark Senokot-S®.

192R R-14 Rev. 02/13

Questions or comments?

OTC - QUESTIONS SECTION

 1-800-645-2158 

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Senexon-S 50mg/8.6mg bingo card labelSenexon-S 50mg/8.6mg bingo card label 

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-4086-01EA - Each0536-4086af38146a-a60f-4c1c-9038-38a930152ea612012-07-24
0536-4086-10EA - Each0536-4086eb55d6fe-9265-49bf-8f42-35b29c4f319f12012-07-24

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0615-80830615-8083-39
0536-4086

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
DOCUSATE SODIUMF05Q2T2JA0ACTIB
SENNOSIDES A AND B1B5FPI42ENACTIB
CARNAUBA WAXR12CBM0EIZIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
D&C YELLOW NO. 1035SW5USQ3GIACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
HYPROMELLOSES3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
SODIUM BENZOATEOJ245FE5EUIACT
STEARIC ACID4ELV7Z65APIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2f7a9208-3925-4cf7-9a22-0d9b702eb344baace5c9-ac2b-4f12-b4e7-e396dd8238f02017-01-19WarningsExact identifier
spl id: 2f7a9208-3925-4cf7-9a22-0d9b702eb344
spl set id: baace5c9-ac2b-4f12-b4e7-e396dd8238f0

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.