Label: LAXATIVE DOCUSATE SODIUM WITH SENNA- docusate sodium and sennosides tablet, coated

  • 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 March 5, 2021

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each tablet)Purposes
    Docusate sodium 50 mgStool softener
    Sennosides 8.6 mgStimulant laxative
  • Uses

    • relieves occasional constipation (irregularity)
    • generally produces bowel movement in 6 to 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 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 overtake 2-4 tablets daily
    children 6 to under 12 years of agetake 1-2 tablets daily
    children 2 to under 6 years of agetake up to 1 tablet daily
    children under 2 yearsask a doctor
  • Other information

    • each tablet contains: calcium 20 mg, sodium 3 mg (low sodium)
    • store between 20-25°C (68-77°F)
  • Inactive ingredients

    colloidal silicon dioxide, crosscarmellose sodium, dibasic calcium phosphate, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide

  • Questions?

    Call 1-888-423-0139

  • PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Carton

    NDC 36800-154-01

    *Compare to the active ingredients
    in Colace® 2-IN-1

    Stool
    Softener
    + Stimulant
    Laxative

    DOCUSATE SODIUM 50 mg
    STOOL SOFTENER

    SENNOSIDES 8.6 mg
    STIMULANT LAXATIVE

    For Relief of
    Occasional Constipation

    • Effective
    • Reliable
    • Comfortbale

    100 TABLETS

    actual size

    Principal Display Panel - 100 Tablet Bottle Carton
  • INGREDIENTS AND APPEARANCE
    LAXATIVE DOCUSATE SODIUM WITH SENNA 
    docusate sodium and sennosides tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-861
    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
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Croscarmellose Sodium (UNII: M28OL1HH48)  
    Anhydrous Dibasic Calcium Phosphate (UNII: L11K75P92J)  
    FD&C Blue No. 2--Aluminum Lake (UNII: 4AQJ3LG584)  
    FD&C Red NO. 40 (UNII: WZB9127XOA)  
    Aluminum Oxide (UNII: LMI26O6933)  
    Hypromellose, Unspecified (UNII: 3NXW29V3WO)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Microcrystalline Cellulose (UNII: OP1R32D61U)  
    Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A)  
    Talc (UNII: 7SEV7J4R1U)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorREDScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code S154
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-861-011 in 1 CARTON05/01/2021
    1100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart33405/01/2021
    Labeler - TOPCO ASSOCIATES LLC (006935977)