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 December 27, 2021

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  • DRUG FACTS

  • ACTIVE INGREDIENT

    Active ingredients (in each tablet)

    Docustate sodium 50 mg

    Sennosides 8.6 mg

  • PURPOSE

    Purposes

    Stool softener

    Stimulant laxative

  • INDICATIONS & USAGE

    Uses

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

    Warnings


  • DO NOT USE

    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
  • ASK DOCTOR

    Ask a doctor before use if you have

    • stomach pain
    • nausea
    • vomiting
    • a sudden change in bowel movements that persists over 2 weeks
  • STOP USE

    Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative.

    These could be signs of 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 the 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.
    • if you do not have a comfortable bowel movement by the second day, increase dose by one tablet (do not exceed maximum dosage) or decrease dose until you are comfortable
    agestarting dosagemaximum dosage
    adults and children 12 years of age and older2 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 years½ tablet once a day1 tablet twice a day
    children under 2 yearsask a doctorask a doctor
  • OTHER SAFETY INFORMATION

    Other information

    • each tablet contains: calcium 20 mg, sodium 6 mg (LOW SODIUM)
    • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)

  • INACTIVE INGREDIENT

    Inactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, D&C yellow#10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium benzoate, stearic acid, titanium dioxide

  • QUESTIONS

    Questions or comments?

    Call 1-877-290-4008

  • PRINCIPAL DISPLAY PANEL

    192R-Timely-SennaS-1000-bottle-label192label

  • 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)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    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)
    Registrant - TIME CAP LABORATORIES, INC (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    TIME CAP LABORATORIES, INC.037052099manufacture(49483-081)
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