Label: SENNA PLUS- docusate sodium 50 mg and sennosides 8.6 mg tablet, film coated

  • NDC Code(s): 70000-0520-1
  • Packager: CARDINAL HEALTH, 110 DBA LEADER
  • 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 June 29, 2021

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  • Active Ingredients (in each tablet)

    Docusate Sodium 50 mg

    Sennosides 8.6 mg

  • Purpose

    Stool Softener

    Laxative

  • Uses

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

    Do not use

    • if you are 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 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 the 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 and 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 10 mg, sodium 5 mg, Very Low Sodium
    • store at 20-25°C(68-77°F); excursions permitted between 15o-30oC (59o-86oF)
  • Inactive ingredients

    croscarmellose sodium, D&C Yellow# 10, dicalcium phosphate, FD&C Yellow #6, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium benzoate, talc, titanium dioxide

  • Questions or comments?

    (866) 562-2756 (Mon-Fri 8 AM to 4 PM EST)

  • PRINCIPAL DISPLAY PANEL

    LEADER TM

    NDC 70000-0520-1

    Senna Plus

    Docusate Sodium, 50 mg

    Sennosides, 8.6 mg

    Stool Softener l Laxative

    Dual Action

    Standardized

    Senna Concentrate

    COMPARE TO

    SENOKOT-S® 

    active ingredients*

    100% Money

    Back Guarantee

    30 TABLETS

    Leader Senna Plus Tablet 30 ct. Product Label

  • INGREDIENTS AND APPEARANCE
    SENNA PLUS 
    docusate sodium 50 mg and sennosides 8.6 mg tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0520
    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
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colororange (ORANGE COLOR) Scoreno score
    ShapeROUND (ROUND TABLET) Size10mm
    FlavorImprint Code PH32
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0520-130 in 1 CARTON10/23/2019
    130 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33410/23/2019
    Labeler - CARDINAL HEALTH, 110 DBA LEADER (063997360)
    Registrant - Pharbest Pharmaceuticals, Inc. (557054835)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharbest Pharmaceuticals, Inc.557054835manufacture(70000-0520) , analysis(70000-0520) , pack(70000-0520) , label(70000-0520)
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