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

  • NDC Code(s): 54629-640-01
  • Packager: National Vitamin Company
  • 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 June 29, 2016

If you are a consumer or patient please visit this version.

  • Active ingredient

    Docusate Calcium 240 mg

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  • Purpose

    Stool Softener

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  • 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.
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  • 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.
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  • Ask a Doctor Before Use

    if you notice a sudden change in bowel habits that persists over a period of two weeks.

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  • Stop Use and Ask a Doctor If

    You have rectal bleeding.
    You fail to have a bowel movement after use.
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  • If Pregnant or Breast Feeding

    Ask a healthcare professional before use.

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  • Keep Out of Reach of Children.

    In case of overdose, get medical help or contact a Poison Control Center immediately.

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  • 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.

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  • Other Information

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

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

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  • Questions or Comments

    Call 1 (800) 682-9862

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  • Package/Label Principal Display Panel

    NDC 54629-0640-01

    LIFE-LINE®

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

    LIFE-LINE VITAMINS
    U.S.A.
    Since 1974

    Manufactured and Distributed by
    NATIONAL VITAMIN COMPANY
    Casa Grande, AZ 85122

    Label

    Label

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  • INGREDIENTS AND APPEARANCE
    DOCUSATE CALCIUM 240 MG SODIUM FREE 
    docusate calcium capsule, liquid filled
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:54629-640
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DOCUSATE CALCIUM (UNII: 6K7YS503HC) (DOCUSATE - UNII:M7P27195AG) DOCUSATE CALCIUM 240 mg
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color RED Score no score
    Shape OVAL Size 15mm
    Flavor Imprint Code NV02
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54629-640-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2016
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part334 02/01/2016
    Labeler - National Vitamin Company (102098324)
    Registrant - National Vitamin Company (102098324)
    Establishment
    Name Address ID/FEI Business Operations
    National Vitamin Company 102098324 MANUFACTURE(54629-640) , ANALYSIS(54629-640)
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