Label: DOCUSATE SODIUM AND SENNOSIDES capsule, liquid filled

  • NDC Code(s): 35916-0449-2
  • Packager: SOFTGEL HEALTHCARE PRIVATE LIMITED
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 22, 2024

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  • Active ingredient (in each softgel)

    Docusate Sodium 50 mg

    Sennosides 8.6 mg

  • Purpose

    Stool softener

    Laxative

  • Uses

    • relieves occasional constipation (irregularity)
    • generally causes bowel movement in 6-12 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 movements 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 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 accidental overdose, seek professional assistance or contact a Poison Control Center right away.

  • Directions

    • take preferably at bedtime or as directed by a doctor.
      AgeStarting Dosage Maximum Dosage
      adults and children 12 years of age and older2 softgels once a day4 softgels twice a day
      children 6 to 12 years of age1 softgel once a day2 softgels twice a day
      children under 6 years of ageask a doctorask a doctor

  • Other information

    • each softgel contains: Sodium 3 mg
    • store at 25°C (77°F); excursions permitted between 15°- 30°C (59°- 86°F)
  • Inactive ingredients

    Propylene glycol, Povidone, Colloidal Silicon Dioxide, Yellow wax, Polyethylene glycol 400, Gelatin, Glycerin, Sorbitol Sorbitan Solution, FD&C Red No.40, Titanium dioxide and Purified water.

  • PRINCIPAL DISPLAY PANEL

    Bottle Label

  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM AND SENNOSIDES 
    docusate sodium and sennosides capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35916-0449
    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
    POVIDONE K30 (UNII: U725QWY32X)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SORBITOL (UNII: 506T60A25R)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    1,4-SORBITAN (UNII: AV0YTZ4E6J)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorred ((Opaque)) Scorescore with uneven pieces
    ShapeOVALSize5mm
    FlavorImprint Code 903
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35916-0449-2500 in 1 BOTTLE; Type 0: Not a Combination Product04/22/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00704/22/2024
    Labeler - SOFTGEL HEALTHCARE PRIVATE LIMITED (675584180)
    Establishment
    NameAddressID/FEIBusiness Operations
    SOFTGEL HEALTHCARE PRIVATE LIMITED675584180manufacture(35916-0449)
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