Label: SENNA-S- docusate sodium and sennosides tablet, 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 June 1, 2020

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  • ACTIVE INGREDIENT

    Active ingredients (in each tablet)

    Docustate sodium 50 mg

    Sennosides 8.6 mg

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, d-c yellow#10 aluminum lake fd&c yelow#6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium benzoate, stearic acid, titanium dioxide

  • PURPOSE

    stool softner, laxative

  • INDICATIONS & USAGE

    Uses:

    Relieves occasional constipation (irregularity); generally causes bowel movement in 6-12 hours

  • DOSAGE & ADMINISTRATION

    Directions:

    • Take preferably at bedtime or as directed by a doctor.
    • If you do not have a comfortable bowel movement by the second day, increase dose by one tablet (not to exceed maximum dosage) or decrease dose until you are comfortable.
    • Adults and children 12 years and over - starting dosage: 2 tablets once a day maximum dosage: 4 tablets twice a day
    • Children 6 to under 12 years - starting dosage: 1 tablet once a day maximum dosage: 2 tablets twice a day
    • Children to 2 to under 6 years - starting dosage: 1/2 tablet once a day maximum dosage: 1 tablet twice a day
    • Children under 2 years - Ask a doctor

  • WARNINGS

    WARNINGS:

    Do not use this product this product:

    • If you are presently taking mineral oil, unless directed by a doctor
    • Laxative products for longer than 1 week unless directed by a doctor
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • PRINCIPAL DISPLAY PANEL

    60 ct

  • INGREDIENTS AND APPEARANCE
    SENNA-S 
    docusate sodium and sennosides tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41226-192
    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
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColororangeScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code TCL081
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41226-192-0660 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33406/01/2020
    Labeler - KROGER (006999528)
    Registrant - TIME CAP LABORATORIES, INC (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    TIME CAP LABORATORIES, INC037052099manufacture(41226-192)
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