Label: NATURAL VEGETABLE LAXATIVE AND STOOL SOFTENER- docusate sodium and sennosides tablet

  • NDC Code(s): 21130-219-03
  • Packager: BETTER LIVING BRANDS LLC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 25, 2024

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

  • Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each tablet)

    Docusate sodium 50 mg

    Sennosides 8.6 mg

  • PURPOSE

    Purposes

    Stool softener

    Laxative

  • INDICATIONS & USAGE

    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/PHARMACIST

    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 use 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 the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

  • DOSAGE & ADMINISTRATION

    Directions

    • take preferably at bedtime or as directed by a doctor
    agestarting dose maximum dosage
    adults and children 12 years of age and over

    2 tablets once a day

    4 tablets twice a day

    children 6 to under 12

    years
    1 tablet once a day2 tablets twice a day

    children 2 to under 6

    years

    ½ tablet once a day

    1 tablet twice a day
    children under 2 years

    ask a doctor

    ask 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_Albertsons_Lbl_30ct192R_Albertsons_IFC_30ct

  • INGREDIENTS AND APPEARANCE
    NATURAL VEGETABLE LAXATIVE AND STOOL SOFTENER 
    docusate sodium and sennosides tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-219
    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
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    Product Characteristics
    ColororangeScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code TCL081
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-219-031 in 1 CARTON12/14/2023
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00712/14/2023
    Labeler - BETTER LIVING BRANDS LLC. (009137209)
    Registrant - TIME CAP LABORATORIES, INC. (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    TIME CAP LABORATORIES, INC.037052099manufacture(21130-219)