Label: SENOKOT-S- standardized senna concentrate and docusate sodium tablet

  • NDC Code(s): 67618-310-01, 67618-310-30, 67618-310-60
  • Packager: Avrio Health L.P.
  • 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 August 17, 2020

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  • INDICATIONS & USAGE

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each tablet)

    Docusate sodium         50 mg

    Sennosides                      8.6 mg

  • PURPOSE

    Purpose

    Stool softener

    Laxative

  • WHEN USING

    Uses

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

    Warnings

  • DO NOT USE

    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 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

    Stop using 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.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • 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.

  • DOSAGE & ADMINISTRATION

    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 day4 tablets twice a day
    children 6 to under 12 years1 tablet once a day2 tablets twice a day
    children 2 to under 6 years1/2 tablet once a day1 tablet twice a day
    children under 2 yearsask a doctorask a doctor
  • HOW SUPPLIED

    Other information

    • each tablet contains: calcium 7 mg, sodium 4 mg VERY LOW SODIUM
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • INACTIVE INGREDIENT

    Inactive ingredients

    Inactive ingredients croscarmellose sodium, dicalcium phosphate, FD&C Yellow #5 Lake*, FD&C Yellow #6 Lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, polyethylene glycol, sodium benzoate, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide, triacetin

    ©2020

    Avrio Health L.P.

    305627-0A

  • PRINCIPAL DISPLAY PANEL

    Senokot-S 30 Tablets Carton
    NDC: 67618-310-30

    Senokot-S 30 Tablets Carton
  • INGREDIENTS AND APPEARANCE
    SENOKOT-S 
    standardized senna concentrate and docusate sodium tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67618-310
    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)  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code P
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67618-310-011 in 1 CARTON10/01/1974
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:67618-310-301 in 1 CARTON10/01/1974
    230 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:67618-310-601 in 1 CARTON10/01/1974
    360 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 finalpart33410/01/1974
    Labeler - Avrio Health L.P. (141916531)
    Registrant - Purdue Pharma LP (932323652)
    Establishment
    NameAddressID/FEIBusiness Operations
    Contract Pharmacal Corporation968334974MANUFACTURE(67618-310)