Label: SENNA-S- sennosides 8.6mg and docusate sodium 50mg 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 April 12, 2022

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  • Active ingredient (in each tablet)

    Sennosides from Senna Concentrate 8.6 mg

    Docusate sodium 50 mg

  • Purpose

    Laxative
    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 
    • you 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 immediately.

  • Directions

    • take preferably at bedtime or as directed by a doctor
    • Adults and children 12 years and over: 2 tablets once a day; maximum 4 tablets twice a day
    • Children 6 to 12 years of age: 1 tablet once a day; maximum 2 tablets twice a day
    • Children 2 to under 6 years: 1/2 tablet once a day; maximum 1 tablet twice a day
    • Children under 2 years of age: ask a doctor
  • Other information

    • each tablet contains 8 mg of Calcium, 3 mg Sodium, Very Low Sodium
    • Store at controlled room temperature 150-300C (590-860F)
  • Inactive ingredients

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

  • Questions?

    Adverse drug event call: (866) 562-2756

  • PRINCIPAL DISPLAY PANEL

    Preferred plus PharmacyTM

    NDC 61715-149-60

    60 Tablets

    Senna-S

    (standard senna concentrate

    plus docusate sodium)

    Gentle Natural

    Vegetable Laxative

    Compare to the Active Ingredients in Senokot-S®†

    Preferred Plus Senna-S 60 Ct.

  • INGREDIENTS AND APPEARANCE
    SENNA-S 
    sennosides 8.6mg and docusate sodium 50mg tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61715-149
    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, ANHYDROUS (UNII: L11K75P92J)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colororange (ORANGE COLOR) Scoreno score
    ShapeROUND (round shape) Size10mm
    FlavorImprint Code PH32
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61715-149-601 in 1 CARTON08/01/2018
    160 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33408/01/2018
    Labeler - Kinray Inc. (012574513)
    Registrant - Pharbest Pharmaceuticals Inc. (557054835)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharbest Pharmaceutical Inc.557054835analysis(61715-149) , manufacture(61715-149) , pack(61715-149) , label(61715-149)
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