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

  • NDC Code(s): 49483-081-00, 49483-081-01, 49483-081-10
  • Packager: TIME CAP LABORATORIES, INC
  • 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 February 18, 2019

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Each Tablet contains:

    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

  • 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 to2 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

  • INDICATIONS & USAGE

    Uses:

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

  • WARNINGS

    WARNINGS:

    Do not use 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

    192label

  • INGREDIENTS AND APPEARANCE
    SENNA TIME S 
    docusate sodium-sennosides tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-081
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
    SENNOSIDES A AND B (UNII: 1B5FPI42EN) (SENNOSIDES A AND B - UNII:1B5FPI42EN) SENNOSIDES A AND B8.6 min
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    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 GLYCOL (UNII: 3WJQ0SDW1A)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColororangeScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code TCL081
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49483-081-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/14/2018
    2NDC:49483-081-101000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/14/2018
    3NDC:49483-081-00100000 in 1 CARTON; Type 0: Not a Combination Product12/14/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33405/14/2012
    Labeler - TIME CAP LABORATORIES, INC (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    TIME CAP LABORATORIES, INC.037052099manufacture(49483-081)