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
  • 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 May 11, 2023

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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 not finalpart33405/11/2023
    Labeler - Reese Pharmaceutical Co (004172052)
    Registrant - Reese Pharmaceutical Co (004172052)
    Establishment
    NameAddressID/FEIBusiness Operations
    Swiss Caps Romania565466997manufacture(10956-891)
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