Label: STOOL SOFTENER- docusate sodium capsule, liquid filled 

  • Label RSS
  • NDC Code(s): 41520-115-10, 41520-115-20, 41520-115-25
  • Packager: Care One (American Sales Company)
  • 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 12/12

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

  • Active Ingredient (in each capsule)

    Docusate Sodium 100 mg

    Purpose

    Stool softener

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  • 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.
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  • 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 one 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 breast-feeding,

    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.

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  • Directions

    • adults and children 12 years and over: take 1- 2 capsules preferably at bedtime
    • children 6 to 12 years of age: take 1 capsule at bedtime
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  • 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®
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  • Inactive Ingredients

    D&C Red #33, edible ink, 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.

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  • Principal Display Panel

    Compare to active ingredient of COLACE®*

    stool softener

    Docusate sodium 100 mg

    Distributed by: American Sales Company

    4201 walden avenue, Lancaster, NY 14086

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  • Product Label

    CareOne

    Docusate Sodium 100 mg

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  • INGREDIENTS AND APPEARANCE
    STOOL SOFTENER 
    docusate sodium capsule, liquid filled
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:41520-115
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 100 mg
    Inactive Ingredients
    Ingredient Name Strength
    FD&C RED NO. 40  
    FD&C YELLOW NO. 6  
    GELATIN  
    GLYCERIN  
    POLYETHYLENE GLYCOLS  
    PROPYLENE GLYCOL  
    SORBITOL  
    D&C RED NO. 33  
    TITANIUM DIOXIDE  
    FD&C BLUE NO. 1  
    WATER  
    Product Characteristics
    Color RED, WHITE Score no score
    Shape OVAL Size 13mm
    Flavor Imprint Code P10;51A
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41520-115-25 1 in 1 BOX
    1 25 in 1 BOTTLE
    2 NDC:41520-115-10 100 in 1 BOTTLE
    3 NDC:41520-115-20 250 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part334 07/20/2010
    Labeler - Care One (American Sales Company) (809183973)
    Registrant - P and L Development of New York Corporation (800014821)
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