FDA.reportPublic FDA data

SENNA-S

Manufacturer
STRATEGIC SOURCING SERVICES LLC | Geri-Care Pharmaceutical Corp
Effective date
2024-07-09
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 20:59:30

Label at a glance#

ProductSENNA-S
Active ingredientSENNOSIDES, DOCUSATE SODIUM
Label structure9 sections

Indications and uses

relieves occasional constipation (irregularity) this product generally produces a bowel movement in 6 to 12 hours

Dosage and administration

• If taking the starting dosage, take preferably at bedtime; or as directed by a doctor. • If taking the maximum dosage, take in the morning and at bedtime. 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...

Storage and handling

each tablet contains: calcium 20 mg, sodium 3 mg. Very low sodium. store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F).

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Docusate Sodium 50 mg
Sennosides 8.6 mg

Purpose

OTC - PURPOSE SECTION

Stool softener

Laxative

Uses

INDICATIONS & USAGE SECTION

  • relieves occasional constipation (irregularity)
  • this product generally produces a bowel movement in 6 to 12 hours

Warnings

WARNINGS 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
Ask a doctor before use if you

• have stomach pain, nausea or vomiting
• have noticed a sudden change in bowel habits that lasts over two weeks

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.

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. In case of overdose, get medical help or contact a Poison Control Center right away 800-222-1222..

Directions

DOSAGE & ADMINISTRATION SECTION


• If taking the starting dosage, take preferably at bedtime; or as directed by a doctor.
• If taking the maximum dosage, take in the morning and at bedtime.

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

STORAGE AND HANDLING SECTION

  • each tablet contains: calcium 20 mg, sodium 3 mg. Very low sodium.
  • store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

cellulose, croscarmellose sodium, dicalcium phosphate, FD&C yellow #6 lake, hypromellose, magnesium stearate, PEG, silica, talc, titanium dioxide.

Questions or Comments?

OTC - QUESTIONS SECTION

Call 833-358-6431 Monday to Friday 9:00am to 7:00pm EST

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-0167-1EA - Each70677-016769d42214-229f-4070-bd1f-688857fd611012022-12-07

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70677-016770677-0167-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSL11K75P92JIACT
MAGNESIUM STEARATE70097M6I30IACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
HYPROMELLOSES3NXW29V3WOIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TALC7SEV7J4R1UIACT
SENNOSIDES3FYP5M0IJXACTIB
DOCUSATE SODIUMF05Q2T2JA0ACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT

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
1cd433b4-33f4-9f1b-e063-6294a90a7f55ec818bd2-4dc4-2464-e053-2995a90a41412024-07-09WarningsExact identifier
spl id: 1cd433b4-33f4-9f1b-e063-6294a90a7f55
spl set id: ec818bd2-4dc4-2464-e053-2995a90a4141

Reported adverse events (FAERS/openFDA)#

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