Label: STOOL SOFTENER- docusate calcium capsule, liquid filled

  • NDC Code(s): 59726-170-01
  • Packager: P & L Development of New York Corporation
  • 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 December 1, 2011

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

  • Active Ingredient (in each softgel)

    Docusate Calcium 240mg

    Purpose

    Stool softener

  • Uses

    For relief of occasional constipation. This product generally produces a bowel movement within 12 to72 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 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

    • store at controlled room temperature 15 - 20 degrees C (59-86 degrees 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.
  • Inactive Ingredients

    corn oil, DandC Red #33, edible white ink, FDandC Red #40, gelating, glycerin, purified water and sorbitol special.

  • Questions or comments?

    call toll free: 1-877-753-3935

  • PRINCIPAL DISPLAY PANEL

    8Comapre to the active ingredient in Surfak Stool Softener                      NDC: 59726-170-01

    Sodium Free

    Stool Softener

    Docusate Calcium 240mg

    Gentle Relief of Constipation

    100 softgels



    Distributed by PL Development

    Westbury, NY 11590 USA


  • Product Labeling

    Stool Softener

  • INGREDIENTS AND APPEARANCE
    STOOL SOFTENER 
    docusate calcium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59726-170
    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
    Colorred (RED) Scoreno score
    ShapeOVAL (OVAL) Size8mm
    FlavorImprint Code P58
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59726-170-01100 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33412/01/2011
    Labeler - P & L Development of New York Corporation (800014821)