Label: LEADER STOOL SOFTENER PLUS STIMULANT LAXATIVE - docusate sodium and sennosides a and b tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 03/12

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

  • Active Ingredients (in each tablet)

    Docusate Sodium 50mg
    Sennosides 8.6mg

    Purpose

    Stool softener
    Stimulant Laxative

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  • Uses

    • relieves occasional constipation (irregularity)
    • generally produces a bowel movement within 6 to 12hours.
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  • 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.

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  • 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
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  • 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.
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  • 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.

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  • Questions or comments?

    call toll free:1-800-200-6313

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  • 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.

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  • Product Labeling
  • INGREDIENTS AND APPEARANCE
    LEADER STOOL SOFTENER PLUS STIMULANT LAXATIVE 
    docusate sodium, sennosides tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:37205-349
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 50 mg
    SENNOSIDES A AND B (SENNOSIDES A AND B) SENNOSIDES A AND B 8.6 mg
    Inactive Ingredients
    Ingredient Name Strength
    CARNAUBA WAX  
    SILICON DIOXIDE  
    CROSCARMELLOSE SODIUM  
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE  
    ALCOHOL  
    FD&C BLUE NO. 2  
    FD&C RED NO. 40  
    HYPROMELLOSES  
    MAGNESIUM STEARATE  
    MALTODEXTRIN  
    CELLULOSE, MICROCRYSTALLINE  
    MINERAL OIL  
    CELLULOSE, MICROCRYSTALLINE  
    POLYETHYLENE GLYCOL 400  
    SODIUM BENZOATE  
    STEARIC ACID  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color red (RED) Score no score
    Shape ROUND (ROUND) Size 10mm
    Flavor Imprint Code TLC97;SS1;S44
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:37205-349-78 100 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part334 03/01/2012
    Labeler - Cardinal Health (097537435)
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