Label: DOCUSATE CALCIUM 240 MG SODIUM FREE- docusate calcium capsule, liquid filled

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 31, 2023

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  • Active ingredient

    Docusate Calcium 240 mg

  • Purpose

    Stool Softener

  • Uses

    • For the relief of occasional constipation.
    • Helps to prevent dry, hard stools.
    • 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

    if you notice a sudden change in bowel habits that persists over a period of two 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 overdose, get medical help or contact a Poison Control Center immediately.

  • 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

    Corn Oil, FD&C Blue #1, FD&C Red #40, Gelatin, Glycerin, Ink (Edible), Sorbitol Special.

  • Questions or Comments

    Call 1-855-361-3993                 

  • Package/Label Principal Display Panel

    NDC 50268-266-15

    AvKARE                    

    DOCUSATE
    CALCIUM
    SODIUM-FREE
    STOOL SOFTENER
    240 mg Each
    100 Softgels

    USA
    AV Rev. 05/16 (P)          

    Manufactured for:
    AvKARE, Inc.
    Pulaski, TN 38478

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  • INGREDIENTS AND APPEARANCE
    DOCUSATE CALCIUM 240 MG SODIUM FREE 
    docusate calcium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50268-266(NDC:54629-640)
    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)  
    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
    ShapeOVALSize15mm
    FlavorImprint Code NV02
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50268-266-1550 in 1 BOX05/17/2017
    1NDC:50268-266-111 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00705/17/2017
    Labeler - AvPAK (832926666)
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