Label: PREFERRED STOOL SOFTENER- docusate calcium capsule, liquid filled

  • NDC Code(s): 10956-891-00
  • Packager: Reese Pharmaceutical Co
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 18, 2024

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  • Active ingredient

    Docusate Calcium 240 mg

  • Purpose

    Stool Softener

  • Uses

    • For the 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.
    • When abdominal pain, nausea or vomiting are present.
    • For longer than one week unless directed by a doctor.
  • Ask a Doctor Before Use

    ■ 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.
  • If Pregnant or Breast Feeding

    Ask a healthcare professional before use.

  • Keep Out of Reach of Children.

    In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    Adults and Children over 12 years of age

    Take orally 1 softgel daily for 2 to 3 days or until bowl movements are normal, or as directed by a doctor.

    Children under 12 years of age

    Do not use this product for children under 12 years of age, unless directed by a doctor.

  • Other Information

    • Store at room temperature between 15ºC to 25ºC (59ºF to 77ºF).
    • Do not use if either seal is broken or missing.
  • Inactive Ingredients

    FD&C Blue #1, FD&C Red #40, Gelatin, Glycerin, Sorbitol Special.

  • Questions or Comments

  • Package/Label Principal Display Panel

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  • INGREDIENTS AND APPEARANCE
    PREFERRED STOOL SOFTENER 
    docusate calcium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10956-891
    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
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVALSize19mm
    FlavorImprint Code SCU
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10956-891-00100 in 1 BOTTLE; Type 0: Not a Combination Product05/11/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00705/11/2023
    Labeler - Reese Pharmaceutical Co (004172052)
    Registrant - Reese Pharmaceutical Co (004172052)
    Establishment
    NameAddressID/FEIBusiness Operations
    Swiss Caps Romania565466997manufacture(10956-891)
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