Label: DOCUSATE CALCIUM 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 September 7, 2011

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  • Active ingredient(s)

    Docusate Calcium

  • Purpose

    Stool Softener

  • Use(s)

    for relief of occasional constipation. This product generally produces a bowel movement within 12 to 72 hours.

  • Warnings

    Do not use

    -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.

    Ask a doctor or pharmacist 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

    Pregnancy/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 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

  • Other information

    -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

  • Storage

    Store at controlled room temperature 15 degrees-30 degrees C (59 degrees-86 degrees F)

  • Inactive ingredients

    Corn oil, D&C Red #33, FD&C Red #40, gelatin, glycerin, purified water and sorbitol special.

  • Questions

    Adverse Drug Event Call: (800) 616-2471

    Distributed by: Rugby Laboratories, Inc. Duluth GA 30097

    Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320

  • Principal Display Panel

    Docusate Calcium Softgel Capsules

    240mg

    Docusate Calcium 240mg

  • INGREDIENTS AND APPEARANCE
    DOCUSATE CALCIUM 
    docusate calcium capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-980(NDC:0536-3755)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCUSATE CALCIUM (UNII: 6K7YS503HC) (DOCUSATE - UNII:M7P27195AG) DOCUSATE CALCIUM240 mg
    Inactive Ingredients
    Ingredient NameStrength
    CORN OIL (UNII: 8470G57WFM)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorREDScoreno score
    ShapeCAPSULESize21mm
    FlavorImprint Code P58
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21695-980-0707 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33407/01/2010
    Labeler - Rebel Distributors Corp (118802834)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rebel Distributors Corp118802834RELABEL, REPACK
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