Label: STOOL SOFTENER AND STIMULANT LAXATIVE- docusate sodium, sennosides tablet

  • 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 4, 2022

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  • ACTIVE INGREDIENT

    Active ingredients (in each tablet)

    Docusate sodium 50 mg

    Sennosides 8.6 mg

  • PURPOSE

    Purposes

    Stool Softener

    Stimulant laxative

  • USES

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

    Warnings

    • laxative products for longer than 1 week unless told to do so by a doctor
    • if you are presently taking mineral oil, unless told to do so by a doctor

    Ask a doctor before use if you have

    • stomach pain
    • nausea
    • vomiting
    • noticed a sudden change in bowel habits that lasts over 2 weeks

    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.

    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 right away.

  • DIRECTIONS

    • take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses

      adults and children 12 years and older take 2-4 tablets daily

      children 6 to under 12 years of age take 1-2 tablets daily

      children 2 to under 6 years of age take up to 1 tablet daily

      children under 2 years ask a doctor

  • OTHER INFORMATION

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

    carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C red #40 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

    HEB209R-240ct-peelbackHEB209R-240ct

  • INGREDIENTS AND APPEARANCE
    STOOL SOFTENER AND STIMULANT LAXATIVE 
    docusate sodium, sennosides tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-549
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
    SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Product Characteristics
    ColorredScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code TCL097
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37808-549-29240 in 1 BOTTLE; Type 0: Not a Combination Product05/04/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33402/04/2022
    Labeler - H-E-B (007924756)
    Registrant - TIME CAP LABORATORIES, INC. (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    TIME CAP LABORATORIES, INC.037052099manufacture(37808-549)
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