Label: STOOL SOFTENER- docusate sodium capsule

  • 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 09/12

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

  • Active Ingredient (in each softgel)

    Docusate Sodium 100 mg

    Purpose

    Stool softener

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  • Uses

    • temporary 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 abdominal pain, nausea or vomiting are present

    Ask a doctor before use if

    • you notice a sudden change in bowel habits that persists over a period of 2 weeks
    • you are presently taking mineral oil

    Stop use and ask a doctor if

    • rectal bleeding or failure to have a bowel movement occur after use which may indicate a serious condition 
    • you need to use a laxative for more than 1 week

    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: 1-800-222-1222

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  • Directions

    • take with a glass of water
     adults and children 12 years of age and over  take 1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses.
     children 2 to under 12 years of age  take 1 softgel daily
     children under 2 years of age  ask a doctor
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  • Other information

    • each softgel 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.
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  • Inactive Ingredients

    edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water and sorbitol special.

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  • Principal Display Panel

    †Compare to Dulcolax® Stool Softener active ingredient

    STOOL SOFTENER

    DOCUSATE SODIUM 100 mg

    †This product is not manufactured or distributed by Boehringer Ingelheim Consumer Healthcare, owner of the registered trademark of Dulcolax®.

    Another quality product distributed by McKesson

    one post street, San Francisco, CA 94104

    Money back gurantee

    Please visit us at www.sunmarkbrand.com

    Questions or comments? Call toll free 1-877-753-3935

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  • Product Label

     sunmark stool softener 25 count

    docusate sodium 100 mg

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  • INGREDIENTS AND APPEARANCE
    STOOL SOFTENER 
    docusate sodium capsule
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49348-917
    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  
    WATER  
    SORBITOL  
    Product Characteristics
    Color ORANGE Score no score
    Shape OVAL Size 13mm
    Flavor Imprint Code P51
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49348-917-05 1 in 1 BOX
    1 25 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part334 08/24/2010
    Labeler - Mckesson (Sunmark) (177667227)
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