Label: STOOL SOFTENER- docusate calcium capsule, liquid filled

  • 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 November 28, 2018

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  • Active ingredient (in each softgel)

    Docusate calcium 240 mg

  • Purpose

    Stool softener laxative

  • Uses

    • for relief of occasional constipation
    • this product generally produces a bowel movement within 12 to 72 hours
  • Warnings

    Do not use

    if you are currently taking mineral oil, unless directed 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 or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
    • you need to use a laxative for more than 1 week

    If pregnant or breast-feeding,

    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 12 years of age and over: take 1 softgel daily or as directed by a doctor
    • children under 12 years of age: ask a doctor
  • Other information

    • store between 20-25ºC (68-77ºF); excursions permitted between 15-30ºC (59-86ºF)
  • Inactive ingredients

    corn oil, D&C red #33*, edible white ink, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, purified water, sorbitol special

    *contains one or more of these ingredients

  • Questions or comments?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • HOW SUPPLIED

    Product: 76413-354

    NDC: 76413-354-30 30 CAPSULE, LIQUID FILLED in a BOTTLE, PLASTIC

  • STOOL SOFTENER (DOCUSATE CALCIUM) CAPSULE, LIQUID FILLED

    Label Image
  • INGREDIENTS AND APPEARANCE
    STOOL SOFTENER 
    docusate calcium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76413-354(NDC:70677-0027)
    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 BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    Product Characteristics
    ColorREDScoreno score
    ShapeCAPSULESize18mm
    FlavorImprint Code P58;SCU
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76413-354-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/28/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart33403/31/2017
    Labeler - Central Texas Community Health Centers (079674019)
    Establishment
    NameAddressID/FEIBusiness Operations
    Travis County Healthcare District797039398RELABEL(76413-354) , REPACK(76413-354)
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