Label: SENEXON-S- docusate sodium -sennosides tablet, coated

  • NDC Code(s): 0536-4086-01, 0536-4086-10
  • Packager: RUGBY LABORATORIES, INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated July 17, 2020

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  • ACTIVE INGREDIENT

    Active ingredients (in each tablet)

    Docusate sodium 50 mg

    Sennosides 8.6 mg

  • WARNINGS

    Do not use if your are taking mineral oil; for longer than one week; when abdominal pain, nausea or vomiting are present
  • KEEP OUT OF REACH OF CHILDREN

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

  • PURPOSE

    Uses: relieves occasional constipation; generally produces bowel movement in 6-12 hours.
  • INACTIVE INGREDIENT

    Inactive ingredients

    carnauba wax, colloidal silicon dioxide, croscarmellose sodium

    D-C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD-C yellow #6 aluminum lake, hypromellose,magnesium stearate, microcrystalline cellulose, polyethyleneglycol, sodium benzoate, stearic acide, Titanium dioxide

  • DOSAGE & ADMINISTRATION

    Dosage and Administration

    Adults and children 12 years and over - 2 tablets once a day - maximum dosage - 4 tablets twice a day

    children 6 to under 12 years - 1 tablet once a day maximum dosage - 2 tablets twice a day

    children 2 to under 6 years - 1/2 tablet once a day - maximum dosage- 1 tablet twice a day

    children uner 2 years - ask a doctor


  • INDICATIONS & USAGE

    RELIEVES OCCASIONAL CONSTIPATION

    GENERALLY PRODUCES BOWEL MOVEMENT IN 6-12 HOURS

  • PRINCIPAL DISPLAY PANEL

    1000 CT

  • INGREDIENTS AND APPEARANCE
    SENEXON-S 
    docusate sodium -sennosides tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-4086
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
    SENNOSIDES A AND B (UNII: 1B5FPI42EN) (SENNOSIDES A AND B - UNII:1B5FPI42EN) SENNOSIDES A AND B8.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    Product Characteristics
    ColororangeScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code TCL081
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-4086-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/17/2020
    2NDC:0536-4086-101000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/17/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33403/16/2011
    Labeler - RUGBY LABORATORIES, INC. (079246066)
    Registrant - TIME-CAP LABS, INC (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    TIME-CAP LABS, INC037052099manufacture(0536-4086)