Label: STOOL SOFTENER STIMULANT LAXATIVE- docusate sodium and sennosides tablet

  • NDC Code(s): 63868-875-01
  • Packager: QUALITY CHOICE (Chain Drug Marketing Association)
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 1, 2024

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  • Active ingredients (in each tablet)

    Docusate sodium 50 mg

    Sennosides 8.6 mg

  • Purpose

    Stool softener

    Stimulant laxative

  • Uses

    • for overnight relief from occasional constipation (irregularity)
    • generally produces bowel movement in 6 to12 hours
  • Warnings

    Do not use

    • laxative products for longer than 1 week unless directed by a doctor
    • if you are now taking mineral oil, 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 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 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 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 oldertake 2-4 tablets daily 
    childrens 6 to under 12 years of age  take1-2 tablets daily
    children 2 to under 6 years of agetake up to 1 tablet daily 
    children under 2  ask a doctor

  • Other Information

    • each tablet contains: calcium 30 mg
    • each tablet contains: sodium 6 mg VERY LOW SODIUM
    • store at 25ºC(77ºF), excursion permitted between 15-30ºC (59-86ºF)
  • Inactive ingredients

    carnauba wax*, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake,  hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol*, sillicon dioxide, sodium benzoate*, stearic acid, talc*, 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 Colace® 2-IN-1

    STOOL SOFTENER

     Plus Stimulant Laxative

    Docusate sodium, 50 mg

    Sennosides, 8.6 mg

    Effective

    Reliable

    Comfortable 

    TABLETS

    †This product is not manufactured or distributed by Avrio Health L.P., Distributor of Colace® 2-IN-1.

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

    Distributed by C.D.M.A. Inc.©

    43157 W. 9 Mile Rd

    Novi, MI 48375

    www.qualitychoice.com

  • Product Label

    Docusate Sodium 50 mg, Sennosides 8.6 mg

    QUALITY CHOICE Stool Softener Plus Stimulant Laxative

  • INGREDIENTS AND APPEARANCE
    STOOL SOFTENER  STIMULANT LAXATIVE
    docusate sodium and sennosides tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-875
    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)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    ColorredScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code TCL097;PSD21;S44
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-875-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/31/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00712/31/2018
    Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)
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