Label: SENNA-S- docusate sodium and sennosides tablet

  • NDC Code(s): 68210-4103-1, 68210-4103-2
  • Packager: Spirit Pharmaceuticals LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 8, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients (in each tablet)

    Docusate sodium 50 mg
    Sennosides 8.6 mg

  • Purpose

    Stool Softner 

    Laxative

  • Uses

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

    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 habits that lasts 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 indicate 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. 1(800)222-1222

  • Directions

    • take preferably at bedtime or as directed by a doctor 
     Age Starting Dosage Maximum Dosage
     adults and children 12 years of age or over 2 tablets once a day 4 tablets twice a day
     children 6 to under 12 years 1 tablet once a day 2 tablets twice a day
     children 2 to under 6 years 1/2 tablet once a day 1 tablet twice a day
     children under 2 years ask a doctor ask a doctor

  • Other information

    • each tablet contains: calcium 19.92 mg, sodium 5.61 mg
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) 
  • Inactive ingredients

    Colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate, D&C yellow No. 10, FD&C Yellow No. 6, hypromellose,magnesium stearate, microcrystalline cellulose, maltodextrin,polyethylene glycol-400, purified water, sodium benzoate, stearic acid, titanium dioxide 

  • Questions or comments?

    1-888-333-9792 

  • PDP

    Cabinet:

    Stool Softener & Laxative

    DOCUSATE SODIUM 50 mg

    SENNOSIDES 8.6 mg

    75 TABLETS

    c

  • INGREDIENTS AND APPEARANCE
    SENNA-S 
    docusate sodium and sennosides tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-4103
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColororangeScoreno score
    ShapeROUND (biconvex) Size10mm
    FlavorImprint Code S35
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68210-4103-175 in 1 BOTTLE; Type 0: Not a Combination Product07/02/2020
    2NDC:68210-4103-2200 in 1 BOTTLE; Type 0: Not a Combination Product07/02/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00707/02/2020
    Labeler - Spirit Pharmaceuticals LLC (179621011)
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