FDA.reportPublic FDA data

Sennosides

Manufacturer
Rugby Laboratories
Effective date
2024-01-11
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:14:51

Label at a glance#

ProductSennosides
Active ingredientSENNOSIDES
Label structure10 sections

Indications and uses

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

Dosage and administration

take preferably at bedtime or as directed by a doctor age starting dosage maximum dosage adults and children 12 years and over 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 2 to under 6 years 1/2 tablet once a day 1 tablet twice a day children under 2 years ask a doctor ask a doctor

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Sennosides 8.6 mg

OTC - PURPOSE SECTION

Purpose

Laxative

Uses 

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use

  • laxative products for longer than one week unless directed by a doctor

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that continues over a period of 2 weeks

OTC - STOP USE SECTION

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE 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
agestarting dosagemaximum dosage

adults and children 12 years and over

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 2 to under 6 years

1/2 tablet once a day

1 tablet twice a day

children under 2 years

ask a doctor

ask a doctor

Other information

OTHER SAFETY INFORMATION

  • each tablet contains: calcium 25 mg
  • each tablet contains: sodium 1 mg (VERY LOW SODIUM)
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

INACTIVE INGREDIENT SECTION

croscarmellose sodium, dicalcium phosphate, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, polyethylene glycol and talc

Questions or comments?

OTC - QUESTIONS SECTION

1-800-645-2158

SPL UNCLASSIFIED SECTION

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

SAVE CARTON FOR COMPLETE DRUG FACTS

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Distributed by: Rugby Laboratories

17177 N Laurel Park Dr., Suite 233,

Livonia, MI 48152

www.rugbylaboratories.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rugby ®

NDC 0536-1168-10

COMPARE TO THE ACTIVE INGREDIENT IN SENOKOT®*

Standardized Senna Concentrate

Sennosides 8.6 mg

SENEXON ®

Natural Vegetable Stimulant Ingredient

Laxative

1000 Tablets

Rugby LabelRugby Label

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1168SENNOSIDES TABLET, FILM COATED [RUGBY LABORATORIES]3Legacy NDC20240112_78fc2b97-ea53-0538-e053-2991aa0a9099.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0536-11680536-1168-10, 0536-1168-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
SENNOSIDES3FYP5M0IJXACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
MALTODEXTRIN7CVR7L4A2DIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
LIGHT MINERAL OILN6K5787QVPIACT
MAGNESIUM STEARATE70097M6I30IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
HYPROMELLOSES3NXW29V3WOIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
TALC7SEV7J4R1UIACT

Source Document#

Source XML

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
0eafc535-7f23-7eab-e063-6294a90a07c878fc2b97-ea53-0538-e053-2991aa0a90992024-01-11WarningsExact identifier
spl id: 0eafc535-7f23-7eab-e063-6294a90a07c8
spl set id: 78fc2b97-ea53-0538-e053-2991aa0a9099

Reported adverse events (FAERS/openFDA)#

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