Label: NON-HABIT FORMING STOOL SOFTENER- docusate sodium capsule, liquid filled

  • 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 January 17, 2012

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  • Active Ingredient (in each softgel capsule)

    Docusate Sodium 100mg

    Purpose

    Stool softener

  • Uses

    • Relieves occasional constipation.
    • Generally produces bowel movement within 12 to72 hours.
  • Warnings - Do not use

    • for longer than one week
    • if you are taking mineral oil
    • when abdominal pain, nausea, or vomiting are present

    Ask a doctor before use if

    you have a sudden change in bowel habits that lasts over two weeks

    Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

    Stop use and ask a doctor if

    • you experience rectal bleeding
    • you fail to have a bowel movement after using this product

    These may indicate a serious condition.

    If pregnant or breastfeeding

    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.

  • Directions

    • adults and children over 12 years and over:1 capsule once daily or in divided doses
    • children 6 to under 12 years: 1 capsule once daily
    • children under 6 years: ask a doctor
  • Other information

    • store at controlled room temperature 15 - 30 degrees C (59-86 degrees F)

    Each capsule contains sodium 6mg

  • Inactive Ingredients

    edible white ink, FDandC Red No. 40, FDandC Yellow No. 6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special.

  • Questions or comments?

    Call 1-800-645-2158, 9am - 5am ET Monday - Friday

  • Principal Display Panel

    Docusate Sodium (Stool Softener) 100mg

  • INGREDIENTS AND APPEARANCE
    NON-HABIT FORMING STOOL SOFTENER 
    docusate sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42254-125(NDC:0536-3756)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM100 mg
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Colororange (orange) Scoreno score
    ShapeOVAL (OVAL) Size13mm
    FlavorImprint Code P51
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42254-125-3030 in 1 BOTTLE
    2NDC:42254-125-6060 in 1 BOTTLE
    3NDC:42254-125-00100 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33403/29/2012
    Labeler - Rebel Distributors Corp (118802834)
    Registrant - PSS World Medical, Inc. (101822862)
    Establishment
    NameAddressID/FEIBusiness Operations
    PSS World Medical, Inc.791528623REPACK(42254-125)
    Establishment
    NameAddressID/FEIBusiness Operations
    STAT RX USA LLC786036330REPACK(42254-125)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dispensing Solutions, Inc.066070785RELABEL(42254-125) , REPACK(42254-125)
    Establishment
    NameAddressID/FEIBusiness Operations
    SCRIPT PAK964420108RELABEL(42254-125) , REPACK(42254-125)
    Establishment
    NameAddressID/FEIBusiness Operations
    Keltman Pharmaceuticals, Inc.362861077REPACK(42254-125)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rebel Distirbutors Corp.118802834RELABEL(42254-125) , REPACK(42254-125)
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