Label: COLISTAT- docusate sodium tablet, film coated

  • 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 July 16, 2015

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  • Active ingredient (in each tablet)

    Docusate Sodium 100 mg

  • Purpose

    Stool Softener

  • Uses

    • for relief of occasional constipation (irregularity).This product generally produces a bowel movement within 12 to 72 hours.
  • Warnings


    Do not use

    • laxative products for longer than one week unless directed to do so by a doctor
    • if you are presently taking mineral oil unless told to do so by a doctor

    Ask a doctor before use if you have

    • stomach pain
    • nausea
    • vomiting
    • noticed  a sudden change in bowel habits that lasts over 2 weeks

    Stop use and ask a doctor if

    • you have rectal bleeding
    • you fail to have a bowel movement after use

    These could be signs of a serious condition.


    If pregnant or breast-feeding,

    ask a doctor 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 12 years of age and older:    		Take 1 tablet as needed,
    not to exceed more than 3
    tablets daily, or as directed
    by a doctor.
    Children under
    12 years of age:    		Consult a doctor before use.






  • Other information

    • Each tablet contains: Calcium 40 mg
    • Each tablet contains: Sodium 10  mg
    • Store at room temperature.
    • Do not use if imprinted safety seal is broken or missing
  • Inactive ingredients

    Croscarmellose Sodium, Dicalcium Phosphate, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Pregelatinized Starch, Silica, Sodium Benzoate, Stearic Acid.

  • Questions?

    If you have any questions or comments, or to report an adverse event, please contact +1 404 256 8817

  • Principal Display Panel

    COLISTAT

    Docusate Sodium

    Stool Softener



    • Gentle
    • Effective
    • Stimulant Free

    50 TABLETS 100 mg each



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  • INGREDIENTS AND APPEARANCE
    COLISTAT 
    docusate sodium tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69975-750
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM100 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeROUND (Round Biconvex with bisect) Size11mm
    FlavorImprint Code GPI;S1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69975-750-0550 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33407/16/2015
    Labeler - Amvilab LLC (006092439)
    Registrant - Gemini Pharmaceuticals, Inc. dba Plus Pharma (055942270)
    Establishment
    NameAddressID/FEIBusiness Operations
    Gemini Pharmaceuticals, Inc. dba Plus Pharma055942270manufacture(69975-750)
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