Label: SENNOSIDES, DOCUSATE SODIUM tablet, film coated

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

Drug Label Information

Updated May 1, 2024

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  • Drug Facts

    Active ingredients (in each tablet)

    Docusate sodium 50 mg
    Sennosides 8.6 mg

  • PURPOSE

    Purposes

    Stool softener
    Stimulant laxative

  • Uses

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

    • 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 lasts over two 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 could be signs 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.

  • 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 SAFETY INFORMATION

    • each tablet contains: calcium 5 mg
    • Store in a dry place at 15° – 30°C (59° – 86°F).
  • INACTIVE INGREDIENT

    corn starch, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 lake, FD&C red #40 lake, FD&C yellow #6 lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, polyethylene glycol, sodium benzoate, sodium lauryl sulfate, stearic acid, talc, titanium dioxide.

  • QUESTIONS

    Questions or comments? 1-800-231-4670

  • SPL UNCLASSIFIED SECTION

    Keep this carton for complete product information

    Tamper Evident:

    Do not use if sealed blister units are broken or damaged.

    Distributed by:
    MAJOR® PHARMACEUTICALS
    Indianapolis, IN 46268
    (800) 616-2471
    www.majorpharmaceuticals.com

  • PRINCIPAL DISPLAY PANEL

    Major

    NDC 0904-7440-61

    Unit Dose

    Sennosides/Docusate Sodium

    8.6mg/50mg

    Stool Softener/Stimulant Laxative

    100 Tablets

    Major Label

  • INGREDIENTS AND APPEARANCE
    SENNOSIDES, DOCUSATE SODIUM 
    sennosides, docusate sodium tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-7440
    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
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C YELLOW NO. 6 ALUMINUM LAKE (UNII: GYP6Z2JR6Q)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    FD&C RED NO. 40 ALUMINUM LAKE (UNII: 6T47AS764T)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TALC (UNII: 7SEV7J4R1U)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    Product Characteristics
    ColorredScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code 49;0
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-7440-6110 in 1 BOX, UNIT-DOSE05/01/2024
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00705/01/2024
    Labeler - Major Pharmaceuticals (191427277)
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