FDA.reportPublic FDA data

SENNA-PLUS

Manufacturer
Geri-Care Pharmaceutical Corp
Effective date
2024-11-28
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:39:47

Label at a glance#

ProductSENNA-PLUS
Active ingredientSENNOSIDES, DOCUSATE SODIUM
Label structure8 sections

Indications and uses

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

Dosage and administration

• do not exceed 8 tablets in 24 hours Age Starting Dose Maximum Dose adults and children 12 years of age and older 2 tablets once a day preferably at bedtime; increase as needed, or as directed by a doctor 4 tablets in the morning and 4 tablets at bedtime children under 12 years ask a doctor

Storage and handling

each tablet contains: calcium 20 mg, sodium 3 mg 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.

Directions

DOSAGE & ADMINISTRATION SECTION

• do not exceed 8 tablets in 24 hours

Age
Starting Dose
Maximum Dose
adults and children 12 years of age and older
2 tablets once a day preferably at bedtime; increase as needed, or as directed by a doctor
4 tablets in the morning and 4 tablets at bedtime
children under 12 years
ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains: calcium 20 mg, sodium 3 mg
  • 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.

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSN6
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCD6
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSY6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57896-555-01SENNA-PLUS100 in 1 BOTTLETABLET1006
57896-555-06SENNA-PLUS60 in 1 BOTTLETABLET606
57896-555-10SENNA-PLUS1000 in 1 BOTTLETABLET10006
57896-555-20SENNA-PLUS200 in 1 BOTTLETABLET2006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57896-555SENNA-PLUS (SENNOSIDES AND DOCUSATE SODIUM) TABLET [GERI-CARE PHARMACEUTICAL CORP]6Current NDC, Legacy NDC, 4 package rows20241130_8a0882ed-f623-2359-e053-2995a90a6f98.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-555-01EA - Each57896-55599ff87f3-bd78-44e5-95d2-ced09a47e88712020-08-06
57896-555-06EA - Each57896-555c097fdf8-843e-480e-b2c8-169d6169722112021-12-08
57896-555-10EA - Each57896-555a8f7f135-b3ac-4250-967e-cb39c37b340612020-06-05
57896-555-20EA - Each57896-5552bd72b42-9f99-4221-abc0-be95352cf75212022-03-09

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
57896-55557896-555-01, 57896-555-06, 57896-555-10, 57896-555-20

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
SENNA-PLUSSENNOSIDES AND DOCUSATE SODIUMGeri-Care Pharmaceutical Corp8a0882ed-f623-2359-e053-2995a90a6f982024-11-28WarningsExact identifier
ndc (package): 57896-555-20
ndc (package): 57896-555-10
ndc (package): 57896-555-01
ndc (package): 57896-555-06
ndc (product): 57896-555
ndc11 (package): 57896055510
ndc11 (package): 57896055501
ndc11 (package): 57896055520
ndc11 (package): 57896055506
spl id: 27ff1c70-104a-4f88-e063-6394a90a7e82
spl set id: 8a0882ed-f623-2359-e053-2995a90a6f98

Reported adverse events (FAERS/openFDA)#

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