Label: STOOL SOFTENER PLUS 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 November 8, 2022

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  • Active Ingredients (in each tablet)

    Docusate Sodium 50 mg
    Sennosides 8.6 mg

    Purpose

    Stool softener

    Laxative

  • Purpose

    Stool softener

    laxative

  • Uses

    • relieves occasional constipation (irregularity)
    • generally causes 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 breastfeeding,

    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 and 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: calcium 20 mg
    • each tablet contains: sodium 6 mg VERY LOW SODIUM
    • store at 25ºC (77º); excursions permitted between 15º-30ºC (59º-86ºF)
  • 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*, silicon dioxide, sodium benzoate, stearic acid, talc* and titanium dioxide.
    *contains one or more of these ingredients

  • Questions or comments?

    call 1-248-449-9300 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    †Compare to the active ingredients in Senokot-S®

    Stool Softener plus laxative

    Stool Softener • Laxative

    Docusate Sodium, 50 mg/ Sennosides, 8.6 mg
    Provides Gentle Relief of: Occasional Constipation

    Tablets

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

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

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    Distributed by C.D.M.A., Inc©

    43157 W. Nine Mile

    Novi, MI 48376-0995

    www.qualitychoice.com

  • Product Label

    Docusate Sodium 50 mg, Sennosides 8.6 mg

    Quality Choice Stool Softener Orange Tablets

  • INGREDIENTS AND APPEARANCE
    STOOL SOFTENER PLUS LAXATIVE 
    docusate sodium, sennosides tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-137
    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)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    DIBASIC CALCIUM PHOSPHATE 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)  
    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;0805;AV;S35
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-137-601 in 1 BOX11/30/2015
    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 finalpart33411/30/2015
    Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)
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