Label: DOCUSATE SODIUM - docusate sodium capsule, liquid filled

  • Category: HUMAN OTC DRUG LABEL

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 December 8, 2016

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  • Active ingredient (in each softgel)

    Docusate sodium 100 mg

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  • Purpose

    Stool softener

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  • Uses

    • relieves occasional constipation (irregularity)
    • generally produces bowel movement in 12 to 72 hours
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  • 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 or vomiting
    • have 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
    • you need to use a stool softener 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.

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  • Directions

    • doses may be taken as a single daily dose or in divided doses
    adults and children 12 years and over                        
    take 1 to 3 softgels daily
    children 2 to under 12 years of age
    take 1 softgel daily
    children under 2 years
    ask a doctor
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  • Other information

    • each capsule contains sodium 6 mg
    • store at room temperature 15o-30oC (59o-86oF)
    • Tamper Evident: Do not use if imprinted safety seal under cap is broken or missing
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  • Inactive ingredients: D&C red #33,Edible ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, sorbitol special
  • Questions?

    Adverse drug event call (800) 687-0176

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  • HOW SUPPLIED

    Product: 50436-1222

    NDC: 50436-1222-1 30 CAPSULE, LIQUID FILLED in a BOTTLE

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  • DOCUSATE SODIUM (DOCUSATE SODIUM ) CAPSULE, LIQUID FILLED
  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM 
    docusate sodium capsule, liquid filled
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:50436-1222(NDC:66424-030)
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 100 mg
    Inactive Ingredients
    Ingredient Name Strength
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Color red (Two toned- white and clear red) Score no score
    Shape OVAL Size 5mm
    Flavor Imprint Code 51A
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50436-1222-1 30 in 1 BOTTLE; Type 0: Not a Combination Product 09/15/2010
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part334 09/15/2010
    Labeler - Unit Dose Services (831995316)
    Establishment
    Name Address ID/FEI Business Operations
    Unit Dose Services 831995316 REPACK(50436-1222) , RELABEL(50436-1222)
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