Label: STOOL SOFTENER- docusate sodium capsule

  • 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 November 15, 2012

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  • Active Ingredient (in each capsule)

    Docusate Sodium 100 mg

    Purpose

    Stool softener

  • Uses

    • for the prevention of dry, hard stools
    • for relief of occasional constipation. This product generally produces a bowel movement within 12 to 72 hours.
  • Warnings - Do not use

    • if you are currently taking mineral oil, unless directed by a doctor
    • when abdominal pain, nausea or vomiting are present
    • for longer than 1 week, unless directed by a doctor

    Ask a doctor before use if

    you notice a sudden change in bowel habits that persists over a period of 2 weeks

    Stop use and ask a doctor if

    • you have rectal bleeding
    • you fail to have a bowel movement after use

    If pregnant or breastfeeding

    ask a health care professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • adults and children 12 years of age and over: take 1- 3 capsules, preferably at bedtime
    • children 6 to 12 years of age: take 1 capsule at bedtime
  • Other information

    • each capsule contains: sodium 6 mg
    • store at controlled room temperature 15o - 30o C (59o- 86o F)
    • do not use if imprinted safety seal under cap is broken or missing.
    • *This product is not manufactured or distributed by Purdue Pharma L.P., owner of the registered trademark Colace®
  • Inactive Ingredients

    D&C Red #33, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, sorbitol special and titanium dioxide. May also contain: FD&C blue #1 and purified water.

  • Questions or Comments?

    Call toll free: 1-877-753-3935

  • Principal Display Panel

    Compare to active ingredient in COLACE®*

    stool softener

    Docusate sodium 100 mg

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

  • Product Label

    valu merchandisers best choice stool softener

    Docusate Sodium 100 mg

  • INGREDIENTS AND APPEARANCE
    STOOL SOFTENER 
    docusate sodium capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63941-146
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM100 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL (UNII: 506T60A25R)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorRED, WHITEScoreno score
    ShapeOVALSize13mm
    FlavorImprint Code P10;51A
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63941-146-011 in 1 BOX
    1100 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart33408/24/2010
    Labeler - Valu Merchandisers Company (Best Choice) (868703513)
    Registrant - P and L Development of New York Corporation (800014821)
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