Label: STIMULANT LAXATIVE PLUS STOOL SOFTENER- docusate sodium 50 mg and sennosides 8.6 mg tablet, film coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 9, 2024

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  • Active Ingredients (in each tablet)

    Docusate Sodium 50 mg

    Sennosides 8.6 mg

  • Purpose

    Stool softener

    Stimulant laxative

  • Uses

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

    Do not use

    • 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 continues over 2 weeks

    Stop use and ask a doctor if

    you have rectal bleeding or fail to have a bowel movement after the use of a laxative.

    These could be sings 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 (1-800-222-1222).

  • 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 over

    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 upto 1 tablet daily

    children under 2 

    ask a doctor

  • Other information

    • each tablet contains: calcium 10 mg, sodium 5 mg, Very Low Sodium
    • store at 20-25°C (68-77°F); excursions permitted between 15-30oC (59-86oF)
  • Inactive ingredients

    croscarmellose sodium, dicalcium phosphate, FD&C Red #40, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium benzoate, talc, titanium dioxide

  • Questions or comments?

    1-800-645-2158

    DISTRIBUTED BY:

    ATLANTIC BIOLOGICALS CORP.

    MIAMI, FL 33179

  • PRINCIPAL DISPLAY PANEL

    NDC 17856-1248-01

    Compare to the

    active ingredients

    in Colace® 2-IN-1*

    Stimulant

    Laxative

    Plus Stool Softener

    Docusate Sodium, 50 mg

    Sennosides, 8.6 mg

    50 mg/ 8.6 mg

    100 TABLETS

    image description

  • INGREDIENTS AND APPEARANCE
    STIMULANT LAXATIVE PLUS STOOL SOFTENER 
    docusate sodium 50 mg and sennosides 8.6 mg tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-1248(NDC:0536-1248)
    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
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorredScoreno score
    ShapeROUND (ROUND TABLET) Size10mm
    FlavorImprint Code PH32
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17856-1248-1100 in 1 BOX, UNIT-DOSE05/09/2024
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM10/22/2019
    Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)
    Registrant - ATLANTIC BIOLOGICALS CORP. (047437707)
    Establishment
    NameAddressID/FEIBusiness Operations
    UNIT DOSE SOLUTIONS360804194repack(17856-1248)
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