Label: SENNA S- docusate sodium and sennosides tablet

  • NDC Code(s): 10135-669-01
  • Packager: Marlex Pharmaceuticals Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 15, 2023

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    SENNOSIDES AND DOCUSATE SODIUM-sennosides, docusate sodium tabletMarlexPharmaceuticals, Inc.

    Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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    SennaS

    Drug Facts

  • Active ingredient (in each tablet)

    Docusate Sodium 50mg Sennosides 8.6 mg

  • Purpose

    Stool softener Stimulant laxative

  • Uses

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

    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

    • stomach pain
    • Nausea
    • Vomiting
    • a sudden change in bowel movements that persists over 2 weeks

    Stop use and ask a doctorif

    you have rectal bleeding or fail to have a bowel movement after use if a laxative. These could be signs of a serious condition.

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

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

  • Directions

    • 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 day2 tablets twice a day
    children 2 to 6 years1/2 tablet once a day1 tablet twice a day
    children under 2 yearsask a doctorask a doctor
  • Other information

    • each tablet contains:calcium 4mg, sodium 8mg
    • store at 20°C to 25°C (68°F to 77°F) excursions permitted between 15°30°C (59°-86°F)
  • Inactive ingredients

    Colloidal silicon dioxide, croscarmellose sodium, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium benzoate, titanium dioxide

    *Compare to the active ingredients in SENOKOT-S®

  • PRINCIPAL DISPLAY PANEL

    NDC 10135-0669-01
    Senna S
    100 TABLET

    669-01

  • INGREDIENTS AND APPEARANCE
    SENNA S 
    docusate sodium and sennosides tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10135-669
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.6 mg
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColororangeScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code S6
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10135-669-011 in 1 CARTON10/01/2018
    1100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00710/01/2018
    Labeler - Marlex Pharmaceuticals Inc (782540215)