Label: STOOL SOFTENER- docusate calcium capsule, liquid filled 

  • Label RSS
  • 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 Calcium 240 mg

    Purpose

    Stool softener

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  • Uses

    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 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: 1-800-222-1222

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  • Directions

    • adults and children over 12 years of age: take 1 softgel daily for several days, or until bowel movements are normal, or as directed by a doctor.
    • children under 12 years of age: take as directed by a doctor.
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  • Other information

    • 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 Chattem, Inc., owner of the registered trademark Surfak® Stool Softener.
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  • Inactive Ingredients

    corn oil, D&C Red #33, edible white ink, FD&C Red #40, gelatin, glycerin, purified water and sorbitol special.

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  • Questions or comments?

    Call toll free 1-877-753-3935

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  • Principal Display Panel

    Stool softener

    For gentle relief of constipation

    DOCUSATE CALCIUM

    Compare to Surfak® Active Ingredient*

    Another quality product distributed by McKesson

    one post street, San francisco, CA 94104

    Money back gurantee

    Please visit us at  www.sunmarkbrand.com

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

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  • Product Label

    Sunmark stool softener

    Docusate calcium 240 mg

     

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  • INGREDIENTS AND APPEARANCE
    STOOL SOFTENER 
    docusate calcium capsule, liquid filled
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49348-280
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DOCUSATE CALCIUM (DOCUSATE) DOCUSATE CALCIUM 240 mg
    Inactive Ingredients
    Ingredient Name Strength
    CORN OIL  
    D&C RED NO. 33  
    FD&C RED NO. 40  
    GELATIN  
    GLYCERIN  
    WATER  
    SORBITOL  
    Product Characteristics
    Color RED Score no score
    Shape CAPSULE Size 21mm
    Flavor Imprint Code P58
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49348-280-10 1 in 1 BOX
    1 100 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part334 07/09/2010
    Labeler - Mckesson (Sunmark) (177667227)
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