FDA.reportPublic FDA data

Sennosides,Docusate sodium

Manufacturer
Rugby Laboratories
Effective date
2022-03-23
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 22:05:10

Label at a glance#

ProductSennosides,Docusate sodium
Active ingredientDOCUSATE SODIUM, SENNOSIDES
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 tablets once a day 2 tablets twice a day children 2 to under 6 years 1/2 tablet once a day 1 tablets 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 ingredients (in each tablet)

Sennosides 8.6 mg

Docusate sodium 50 mg

OTC - PURPOSE SECTION

Purposes

Laxative

Stool softener

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

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

■ laxative products for longer than 1 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 tablets once a day

    2 tablets twice a day

    children 2 to under 6 years

    1/2 tablet once a day

    1 tablets twice a day

    children under 2 years

    ask a doctor

    ask a doctor

Other information

OTHER SAFETY INFORMATION

■ each tablet contains: calcium 11 mg

■ each tablet contains: sodium 4 mg

■ store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

INACTIVE INGREDIENT SECTION

croscarmellose sodium, dicalcium phosphate, FD&C yellow #5 lake†, FD&C yellow #6 lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, polyethylene glycol, sodium benzoate, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide and triacetin

†contains FD&C yellow #5 lake (tartrazine) as a color additive.

Questions or comments?

OTC - QUESTIONS SECTION

1-800-645-2158

SPL UNCLASSIFIED SECTION

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

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

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

Distributed by: Rugby Laboratories

17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152

www.rugbylaboratories.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

THIS PACKAGE IS FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

Rugby ®

NDC 0536-1169-10

Senexon-S

NATURAL VEGETABLE INGREDIENT

STIMULANT LAXATIVE

PLUS STOOL SOFTENER

Docusate Sodium 50 mg

Sennosides 8.6 mg

1000 TABLETS

COMPARE TO THE ACTIVE INGREDIENTS IN SENOKOT-S®*

0490C-1000ct-label0490C-1000ct-label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1169-01EA - Each0536-1169f1e8649b-4385-4af2-9381-d9bed66b201b12019-02-13
0536-1169-10EA - Each0536-116954bc2640-c0b1-4c04-8c4a-b2e083b3871912019-01-24

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0536-11690536-1169-10, 0536-1169-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C YELLOW NO. 6H77VEI93A8IACT
LIGHT MINERAL OILN6K5787QVPIACT
TALC7SEV7J4R1UIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEO7TSZ97GEPIACT
HYPROMELLOSES3NXW29V3WOIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SODIUM LAURYL SULFATE368GB5141JIACT
STARCH, CORNO8232NY3SJIACT
STEARIC ACID4ELV7Z65APIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIACETINXHX3C3X673IACT
DOCUSATE SODIUMF05Q2T2JA0ACTIB
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
SODIUM BENZOATEOJ245FE5EUIACT
SENNOSIDES3FYP5M0IJXACTIB
POLYETHYLENE GLYCOL 400B697894SGQIACT

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
dae81e35-85a4-c319-e053-2995a90a113a780d2e3b-aaff-5ff8-e053-2a91aa0a0c2a2022-03-23WarningsExact identifier
spl id: dae81e35-85a4-c319-e053-2995a90a113a
spl set id: 780d2e3b-aaff-5ff8-e053-2a91aa0a0c2a

Reported adverse events (FAERS/openFDA)#

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