FDA.reportPublic FDA data

Sennosides and Docusate Sodium

Manufacturer
Reliable-1 Laboratories LLC
Effective date
2018-08-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:40:27

Label at a glance#

ProductSennosides and Docusate Sodium
Active ingredientSENNOSIDES, DOCUSATE SODIUM
Label structure14 sections

Indications and uses

relieves occasional constipation (irregularity) generally causes 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 does by one tablet (do not exceed maximum dosage) or decrease does until you are comfortable age starting dosage maximum dosage adults and children 12 years of age and older 2 tablets once a day 4 tablets twice a day children 6 to 12 years 1 tablet once a day 2 tablets twice a day child...

Storage and handling

each tablet contains: calcium 20 mg, sodium 6 mg (LOW SODIUM) store at 25°C (77°F) excursions permitted between 15°30°C (59°-86°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Docusate Sodium 50mg

Sennosides 8.6 mg

Purpose

OTC - PURPOSE SECTION

Stool softener

Stimulant laxative

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Do not use

  • this product if you are presently taking mineral oil, unless directed by a doctor
  • laxative products for longer than 1 week unless directed by a doctor

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • stomach pain
  • nausea
  • vomiting
  • a sudden change in bowel movements that presists over 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 if a laxative. These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, 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 contacnt a Posion 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 does by one tablet (do not exceed maximum dosage) or decrease does until you are comfortable
agestarting dosagemaximum dosage
adults and children 12 years of age and older2 tablets once a day4 tablets twice a day
children 6 to 12 years1 tablet once a day

2 tablets twice a day

children 2 to 6 years1/2 tablet once a day

1 tablet twice a day

children under 2 yearsask a doctorask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains: calcium 20 mg, sodium 6 mg (LOW SODIUM)
  • store at 25°C (77°F) excursions permitted between 15°30°C (59°-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69618-049-01

SENNA PLUS

Sennosides 8.6 mg

Docusate Sodium 50 mg

NATURAL VEGETABLE

LAXATIVE AND STOOL SOFTNER

100 TABLETS

*Compate to the active ingredients in SENOKOT-S®

Senna Plus 1Senna Plus 1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69618-049-01EA - Each69618-04978e88443-ee39-4a6f-b36b-b771578225c512019-01-24

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69618-04969618-049-01

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
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
CARNAUBA WAXR12CBM0EIZIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
SENNOSIDES3FYP5M0IJXACTIB
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SODIUM BENZOATEOJ245FE5EUIACT
STEARIC ACID4ELV7Z65APIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
DOCUSATE SODIUMF05Q2T2JA0ACTIB

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
cf5e92d6-c1a8-5ff2-e053-2a95a90a4140737e9716-8773-89b5-e053-2a91aa0abd1d2021-10-27WarningsExact identifier
spl set id: 737e9716-8773-89b5-e053-2a91aa0abd1d

Reported adverse events (FAERS/openFDA)#

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