Label: SENNOSIDES AND DOCUSATE SODIUM 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 July 28, 2021

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  • Active ingredient

    Docusate Sodium 50mg

    Sennosides 8.6 mg

  • Purpose

    Docusate Sodium...............Stool Softener

    Sennosides.........................Stimulant Laxative

  • Keep Out of Reach of Children

  • Uses

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

    Do Not Use

    • this product if you are presently 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
    • a sudden change in bowel movements that persists 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 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 preferably at bedtime or as directed by a doctor
    • If you do not have a comfortable bowel movement by the second day, increase dose by one tablet (do not exceed the maximum dosage) or decrease dose until you are comfortable.
    AgeStarting DoseMaximum Dose
    Adults and children 12 years of age and over2 tablets once a day4 tablets twice a day
    Children 6 to under 12 years1 tablet once a day2 tablets twice a day
    Children 2 to under 6 years1/2 tablet once a day1 tablets twice a day
    Children under 2 yearsask a doctorask a doctor

    Other Information

    • each tablet contains calcium 20mg, sodium 6mg (LOW SODIUM)
    • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
  • Inactive ingredients

    carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium benzoate, stearic acid, titanium dioxide

  • Package/Label Principal Display Panel

    Package/Label Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    SENNOSIDES AND DOCUSATE SODIUM 
    sennosides and docusate sodium tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63739-432(NDC:49483-081)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SENNOSIDES A AND B (UNII: 1B5FPI42EN) (SENNOSIDES A AND B - UNII:1B5FPI42EN) SENNOSIDES A AND B8.6 mg
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColororangeScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code TCL081
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63739-432-1010 in 1 BOX, UNIT-DOSE11/10/200707/31/2021
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:63739-432-0125 in 1 BOX, UNIT-DOSE11/10/200707/31/2021
    230 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:63739-432-0425 in 1 BOX11/10/200705/31/2013
    330 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:63739-432-0230 in 1 BOX07/28/2021
    410 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33410/11/2007
    Labeler - McKesson Packaging Services a business unit of McKesson Corporation (140529962)
    Establishment
    NameAddressID/FEIBusiness Operations
    Legacy Pharmaceutical Packaging, LLC143213275repack(63739-432) , relabel(63739-432)
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