Label: DOCUSATE SODIUM AND SENNOSIDES capsule, gelatin coated

  • NDC Code(s): 35916-0453-1
  • Packager: Softgel Healthcare Pvt Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 4, 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 DosageMaximum Dosage
      adults and children 12 years of age and older2 softgels once a day4 softgels twice a day
      children 6 to 12 years1 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 Yellow No.6, Titanium dioxide and Purified water.

  • PRINCIPAL DISPLAY PANEL

    Bottle Label

  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM AND SENNOSIDES 
    docusate sodium and sennosides capsule, gelatin coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35916-0453
    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
    WATER (UNII: 059QF0KO0R)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    GELATIN (UNII: 2G86QN327L)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    SORBITOL (UNII: 506T60A25R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colororange (opaque) Scoreno score
    ShapeOVALSize12mm
    FlavorImprint Code 902
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35916-0453-1500 in 1 BOTTLE; Type 0: Not a Combination Product06/04/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00706/04/2024
    Labeler - Softgel Healthcare Pvt Ltd (675584180)
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