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

  • NDC Code(s): 49348-532-12
  • Packager: Strategic Sourcing Services LLC
  • 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 October 18, 2019

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

  • Active ingredients (in each tablet)

    Docusate sodium 50 mg

    Sennosides 8.6 mg

  • Purpose

    Stool softener

    Laxative

  • Uses

    • relieves occasional constipation (irregularity)
    • generally produces bowel movement in 6-12 hours
  • Warnings

  • 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 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 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.

  • 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 preferably at bedtime or as directed by a doctor
     age starting dosage maximum dosage
     adults and children 12 years of age or older 2 tablets
    once a day
     4 tablets
    twice a day
     children 6 to under 12 years 1 tablet
    once a day
     2 tablets
    twice a day
     children 2 to under 6 years 1/2 tablet
    once a day
     1 tablet
    twice a day
     children under 2 years ask a doctor ask a doctor
  • Other Information

    • each tablet contains: sodium 6 mg LOW SODIUM
    • each tablet contains: Calcium 20 mg
    • store at 25o (77o F); excursions permitted between 15o- 30o C (59o-86o F)
  • Inactive ingredients

    carnauba wax*, croscarmellose sodium, D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C blue #2 aluminum lake*, FD&C red #40 aluminum lake*, FD&C yellow #6 aluminum lake, hypromellose*, magnesium stearate, maltodextrin*, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol*, purified water*, silicon dioxide, sodium benzoate, stearic acid, talc*, titanium dioxide

    *contains one or more of these ingredients

  • Questions or comments?

    Call toll free: 1-877-753-3935 Monday- Friday 9AM- 5PM EST

  • Principal Display Panel

    †Compare to Senokot- S® active ingredients

    Natural laxative plus stool softener

    Docusate sodium 50 mg

    Sennosides 8.6 mg

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    Another Quality Product Distributed by McKesson

    One post street, San Francisco, CA 94104

    Money Back Guarantee

    Please visit us at www.sunmarkbrand.com

    †This product is not manufactured or distributed by L.P., owner of the registered trademark Senokot-S®

  • Product Label

    Natural laxative plus stool softener

    Natural laxative plus stool softener

     

  • INGREDIENTS AND APPEARANCE
    NATURAL LAXATIVE  PLUS STOOL SOFTENER
    docusate sodium and sennosides tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-532
    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
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    WATER (UNII: 059QF0KO0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code TCL081;SS1;S35
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49348-532-121 in 1 BOX07/09/201012/30/2021
    160 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart33407/09/201012/30/2021
    Labeler - Strategic Sourcing Services LLC (116956644)