FDA.reportPublic FDA data

Sennosides,Docusate sodium

Manufacturer
Major Pharmaceuticals
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 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 or over 2 tablets once a day 4 tablets twice a day children 6 to under 12 years of age 1 tablet once a day 2 tablets twice a day children 2 to under 6 years of age 1/2 tablet once a day 1 tablets twice a day children under 2 years of age 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

Purposes

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.

Directions

DOSAGE & ADMINISTRATION SECTION

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

    adults and children

    12 years of age or over

    2 tablets

    once a day

    4 tablets

    twice a day

    children 6 to under

    12 years of age

    1 tablet

    once a day

    2 tablets

    twice a day

    children 2 to under

    6 years of age

    1/2 tablet

    once a day

    1 tablets

    twice a day

    children under

    2 years of age

    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, triacetin

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

Questions or comments?

OTC - QUESTIONS SECTION

(800) 616-2471

SPL UNCLASSIFIED SECTION

Tamper Evident: Do not use if sealed blister units are broken or damaged.

Product color may slightly vary due to natural changes of ingredients.

Distributed by:

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0904-6724-61

MAJOR

Unit Dose

SENNA PLUS TABLETS
(Stadardized Senna Concentrate & Docusate Sodium)

8.6/50 mg

100 Tablets

0490C-100ct-label0490C-100ct-label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6724-61EA - Each0904-6724a440e6d6-61d1-401a-864b-c65d3218358c12019-02-13

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
0904-67240904-6724-61

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

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
dae821db-98d6-660e-e053-2995a90a4d1b780b838c-b1f9-442f-e053-2991aa0a77582022-03-23WarningsExact identifier
spl id: dae821db-98d6-660e-e053-2995a90a4d1b
spl set id: 780b838c-b1f9-442f-e053-2991aa0a7758

Reported adverse events (FAERS/openFDA)#

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