Label: LEADER STOOL SOFTENER PLUS STIMULANT LAXATIVE- docusate sodium, sennosides tablet

  • 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 March 5, 2012

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

View All Sections
  • Active Ingredients (in each tablet)

    Docusate Sodium 50mg
    Sennosides 8.6mg

    Purpose

    Stool softener
    Stimulant Laxative

  • Uses

    • relieves occasional constipation (irregularity)
    • generally produces a bowel movement within 6 to 12hours.
  • Warnings - Do not use

    • laxative products for longer than 1 week unless told to do so by a doctor.
    • if you are presently taking mineral oil, unless told to do so 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 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 could be signs of a serious condition

    If pregnant or breastfeeding

    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 immediately.

  • Directions

    Take only by mouth. Doses may be taken as a single daily does or in divided doses.

    • adults and children 12 years and over: take 2-4 tablets daily
    • children 6 to under 12 years of age: take 1-2 tablets daily
    • children 2 to under 6 years of age: take up to 1 tablet daily
    • children under 2: ask a doctor
  • Other information

    • each softgel contains: sodium 6mg VERY LOW SODIUM
    • each tablet contains: calcium 20mg/tablets
    • store at 15 - 30 degrees C (59-86 degrees F), protect from excessive moisture
    • do not use if imprinted safety seal under cap is broken or missing.
    • *This product is not manufactured or distributed by Purdue Products, LP, owner of the registered trademark Peri Colace.
  • Inactive Ingredients

    carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, ethanol, FDandC Blue no2 Aluminum Lake, FDandC Red No40 Aluminum Lake, hypromellose, magnesium stearate, *maltodextrin, microcrystalline cellulose, *mineral oil, *Opadry II red, polyethylene glycol (PEG) 400, *pregelatinized starch, *silicon dioxide 50s, sodium benzoate, stearic acid and titanium dioxide. *May also contain.

  • Questions or comments?

    call toll free:1-800-200-6313

  • PRINCIPAL DISPLAY PANEL

    Comapre to the active ingredient Peri Colace               

    Leader

    Stool Softener plus Stimulant Laxative

    Docusate Sodium 50mg
    Sennosides, 8.6mg

    Relieves of Occasional Constipation
    100 Softgels

    Distributed by Cardinal Health
    Dublin, Ohio 43017
    CIN 1382639

    www.myleader.com
    1-800-200-6313

    All Leader Brand Products are 100% satisfaction guaranteed or return to place of purchase for a full refund.

  • Product Labeling

    Stool Softener

  • INGREDIENTS AND APPEARANCE
    LEADER STOOL SOFTENER PLUS STIMULANT LAXATIVE 
    docusate sodium, sennosides tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-349
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
    SENNOSIDES A AND B (UNII: 1B5FPI42EN) (SENNOSIDES A AND B - UNII:1B5FPI42EN) SENNOSIDES A AND B8.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
    ALCOHOL (UNII: 3K9958V90M)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorred (RED) Scoreno score
    ShapeROUND (ROUND) Size10mm
    FlavorImprint Code TLC97;SS1;S44
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37205-349-78100 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33403/01/2012
    Labeler - Cardinal Health (097537435)
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!