Label: SENNA-S- sennosides and docusate sodium tablet, film coated

  • 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 March 26, 2013

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  • Active Ingredients

    Sennosides from Senna Concentrate 8.6 mg

    Sodium Dioctylsulfosuccinate 50 mg

  • Purposes

    Sennosides from Senna Concentrate 8.6 mg...........Laxative
    Sodium Dioctylsulfosuccinate 50 mg......................Stool Softener

  • Uses

    • Relieves occasional constipation (irregularity)
    • Generally produces a bowel movement in 6-12 hours.
  • Warnings

    Do not use

    • laxative products for longer than 1 week unless directed by a doctor
    • if you are now taking mineral oil, 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 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.

  • Directions

    • take preferably at bedtime or as directed by a doctor

    agestarting dosagemaximum dosage
    adults and children 12 years of age 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 20 mg, sodium 6mg Low Sodium
    • store at room temperature between 15-300C (59-860F)
  • Inactive ingredients

    carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium benzoate, stearic acid, tapoica starch, tartaric acid, titanium dioxide

  • Questions? Adverse drug event call: (866) 562-2756

  • PRINCIPAL DISPLAY PANEL

    PP Senna-S 60ct carton
  • INGREDIENTS AND APPEARANCE
    SENNA-S 
    sennosides and docusate sodium tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61715-019
    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
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    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 GLYCOLS (UNII: 3WJQ0SDW1A)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STARCH, TAPIOCA (UNII: 24SC3U704I)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colororange (orange) Scoreno score
    ShapeROUND (round shape) Size10mm
    FlavorImprint Code S90
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61715-019-601 in 1 CARTON
    160 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33405/10/2011
    Labeler - Kinray Inc. (012574513)
    Registrant - Pharbest Pharmaceuticals Inc. (557054835)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharbest Pharmaceutical Inc.557054835repack(61715-019) , relabel(61715-019)
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