Label: KAO- TIN- docusate calcium capsule, liquid filled

  • NDC Code(s): 0904-5779-40, 0904-5779-60
  • Packager: Major Pharmaceuticals
  • 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 20, 2018

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 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.
  • Inactive Ingredients

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

  • Questions ?

    Adverse Drug Event Call: (800) 616-2471

  • PRINCIPAL DISPLAY PANEL

    NDC 0904-5779-60

    MAJOR KAO- TIN ™

    Docusate Calcium 240 mg

    Stool Softener

    For Mild, Dependable, More natural relief of constipation

    Non- habit forming

    NO SODIUM

    *Compare to the active ingredient in Surfak® Stool Softener         

    Distributed by:

    Major Pharmaceuticals

    31778 Enterprise Drive

    Livonia MI 48150 USA

  • Product Label

    Major Pharmaceuticals Docusate calcium 240 mg

    Docusate Calcium 240 mg

     

  • INGREDIENTS AND APPEARANCE
    KAO- TIN 
    docusate calcium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-5779
    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
    ShapeCAPSULE (OVAL) Size21mm
    FlavorImprint Code P58
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-5779-40500 in 1 BOTTLE; Type 0: Not a Combination Product12/01/201112/31/2020
    2NDC:0904-5779-60100 in 1 BOTTLE; Type 0: Not a Combination Product12/01/201112/31/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart33412/01/201112/31/2020
    Labeler - Major Pharmaceuticals (191427277)