FDA.reportPublic FDA data

Sennosides, Docusate Sodium

Manufacturer
Cardinal Health
Effective date
2022-03-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:05:11

Label at a glance#

ProductSennosides, Docusate Sodium
Active ingredientSENNOSIDES, DOCUSATE SODIUM
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 of age 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 ingredients (in each tablet)

Docusate sodium 50 mg

Sennosides 8.6 mg

OTC - PURPOSE SECTION

Purpose

Stool softener

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

  • 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. 1-800-222-1222

Directions

DOSAGE & ADMINISTRATION SECTION

  • take preferably at bedtime or as directed by a doctor
    agestarting dosagemaximum dosage

    adults and children
    12 years of age and over     		2 tablets once a day4 tablets twice a day
    children 6 to under 12 years1 tablet once a day2 tablets twice a day
    children 2 to under 6 years1/2 tablet once a day1 tablet twice a day
    children under 2 yearsask a doctorask 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 between15º-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, triacetin

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

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-231-4670 Monday - Friday 9AM-5PM EST

SPL UNCLASSIFIED SECTION

†This product is not manufactured or distributed by Purdue Products L.P., owner of registered trademark Senokot-S®.

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com 1-800-200-6313


CARDINAL HEALTH, the Cardinal Health LOGO,
LEADER, and the Leader LOGO are trademarks or
registered trademarks of Cardinal Health.

100% Money Back Guarantee
Return to place of purchase if not satisfied.

12958-11-18

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER TH

NDC 70000-0405-1

Senna Plus

Docusate Sodium, 50 mg | Sennosides, 8.6 mg

Stool Softner | Laxative

Dual Action

Standardized Senna

Concentrate

30 TABLETS

Tablet Image

Actula Size

COMPARE TO

SENOKOT-S®

active ingredients

100% Money Back Guarantee

0490c0490c

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0405-1EA - Each70000-0405a2ee8ca8-5858-4a83-be17-ed35d7871ff612019-08-06

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
70000-040570000-0405-1

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
POLYETHYLENE GLYCOL 400B697894SGQIACT
SENNOSIDES3FYP5M0IJXACTIB
STARCH, CORNO8232NY3SJIACT
TRIACETINXHX3C3X673IACT
DOCUSATE SODIUMF05Q2T2JA0ACTIB
FD&C YELLOW NO. 5I753WB2F1MIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
SODIUM BENZOATEOJ245FE5EUIACT
TALC7SEV7J4R1UIACT
HYPROMELLOSES3NXW29V3WOIACT
STEARIC ACID4ELV7Z65APIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEO7TSZ97GEPIACT
MALTODEXTRIN7CVR7L4A2DIACT
MAGNESIUM STEARATE70097M6I30IACT
LIGHT MINERAL OILN6K5787QVPIACT
SODIUM LAURYL SULFATE368GB5141JIACT
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
c4fcb5b6-0401-bd1b-e053-2995a90adde27c4a8402-4766-50b6-e053-2991aa0a0d852022-03-23WarningsExact identifier
spl id: c4fcb5b6-0401-bd1b-e053-2995a90adde2
spl set id: 7c4a8402-4766-50b6-e053-2991aa0a0d85

Reported adverse events (FAERS/openFDA)#

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