Label: DOCUSATE SODIUM AND SENNOSIDES capsule, gelatin coated

  • NDC Code(s): 35916-0454-1
  • Packager: Softgel Healthcare Pvt Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 22, 2024

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

View All Sections
  • 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 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, gelatin coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35916-0454
    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
    POVIDONE K30 (UNII: U725QWY32X)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    WATER (UNII: 059QF0KO0R)  
    GELATIN (UNII: 2G86QN327L)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    Product Characteristics
    Colorred (opaque) Scoreno score
    ShapeOVALSize12mm
    FlavorImprint Code 903
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35916-0454-1500 in 1 BOTTLE; Type 0: Not a Combination Product06/22/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00706/22/2024
    Labeler - Softgel Healthcare Pvt Ltd (675584180)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!