Label: SENEXON-S- docusate sodium 50mg and sennosides 8.6mg tablet, film coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 24, 2024

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  • Active Ingredients (in each tablet)

    Docusate Sodium 50 mg

    Sennosides 8.6 mg

  • Purpose

    Stool Softener

    Laxative

  • Uses

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

    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
    • vomiting
    • noticed a sudden change in bowel habits that continues over a period of 2 weeks

    Stop use and ask a doctor if

    you have rectal bleeding or fail to have a bowel movement after the use of a laxative.

    These may indicate 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 (1-800-222-1222).

  • Directions

    • take preferably at bedtime or as directed by a doctor

    age

    starting dosage

    maximum dosage

    adults and children 12 years 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 day

    children under 2 years

    ask a doctor

     ask a doctor
  • Other information

    • each tablet contains: calcium 10 mg, sodium 5 mg, Very Low Sodium
    • store at 20-25°C (68-77°F); excursions permitted between 15-30oC (59-86oF)
  • Inactive ingredients

    croscarmellose sodium, D&C Yellow# 10, dicalcium phosphate, FD&C Yellow #6, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium benzoate, talc, titanium dioxide

  • Questions or comments?

    1-800-645-2158

  • SPL UNCLASSIFIED SECTION

    Dist. by: Rugby® Laboratories

    17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152

    www.rugbylaboratories.com

    Rev. 09/19 R-111

  • Principal Display Section

    PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    SENEXON-S 
    docusate sodium 50mg and sennosides 8.6mg tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0615-8331(NDC:0536-1247)
    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
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colororange (ORANGE COLOR) Scoreno score
    ShapeROUND (ROUND TABLET) Size10mm
    FlavorImprint Code PH32
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0615-8331-3930 in 1 BLISTER PACK; Type 0: Not a Combination Product01/07/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)10/02/2019
    Labeler - NCS HealthCare of KY, LLC dba Vangard Labs (050052943)
    Establishment
    NameAddressID/FEIBusiness Operations
    NCS HealthCare of KY, LLC dba Vangard Labs050052943repack(0615-8331)
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