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

  • NDC Code(s): 0536-1247-01, 0536-1247-10
  • Packager: RUGBY LABORATORIES
  • 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 December 21, 2022

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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

  • PRINCIPAL DISPLAY PANEL

    RUGBY

    NDC 0536-1247-10

    Compare to the active ingredients in Senokot-S®*

    Senexon-S

    Docusate Sodium, 50 mg

    Sennosides, 8.6 mg

    Natural Vegetable Laxative

    Ingredient Plus Stool Softener

    1000 TABLETS

    Rugby Senexon-S 1000 ct. Product Label

  • INGREDIENTS AND APPEARANCE
    SENEXON-S 
    docusate sodium 50mg and sennosides 8.6mg tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)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:0536-1247-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/02/2019
    2NDC:0536-1247-101000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/02/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33410/02/2019
    Labeler - RUGBY LABORATORIES (079246066)
    Registrant - Pharbest Pharmaceuticals, Inc. (557054835)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharbest Pharmaceuticals, Inc.557054835manufacture(0536-1247) , analysis(0536-1247) , pack(0536-1247) , label(0536-1247)
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