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

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/12

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

  • Active Ingredient (in each softgel capsule)

    Docusate Sodium 100mg

    Purpose

    Stool softener

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  • Uses

    • Relieves occasional constipation.
    • Generally produces bowel movement within 12 to72 hours.
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  • 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.

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  • 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
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  • Other information

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

    Each capsule contains sodium 6mg

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  • Inactive Ingredients

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

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  • Questions or comments?

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

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  • Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    NON-HABIT FORMING STOOL SOFTENER 
    docusate sodium capsule, liquid filled
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:42254-125(NDC:0536-3756)
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 100 mg
    Inactive Ingredients
    Ingredient Name Strength
    FD&C RED NO. 40  
    FD&C YELLOW NO. 6  
    GELATIN  
    GLYCERIN  
    POLYETHYLENE GLYCOLS  
    PROPYLENE GLYCOL  
    WATER  
    SORBITOL  
    Product Characteristics
    Color orange (orange) Score no score
    Shape OVAL (OVAL) Size 13mm
    Flavor Imprint Code P51
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42254-125-30 30 in 1 BOTTLE
    2 NDC:42254-125-60 60 in 1 BOTTLE
    3 NDC:42254-125-00 100 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part334 03/29/2012
    Labeler - Rebel Distributors Corp (118802834)
    Registrant - PSS World Medical, Inc. (101822862)
    Establishment
    Name Address ID/FEI Business Operations
    PSS World Medical, Inc. 791528623 REPACK(42254-125)
    Establishment
    Name Address ID/FEI Business Operations
    STAT RX USA LLC 786036330 REPACK(42254-125)
    Establishment
    Name Address ID/FEI Business Operations
    Dispensing Solutions, Inc. 066070785 RELABEL(42254-125), REPACK(42254-125)
    Establishment
    Name Address ID/FEI Business Operations
    SCRIPT PAK 964420108 RELABEL(42254-125), REPACK(42254-125)
    Establishment
    Name Address ID/FEI Business Operations
    Keltman Pharmaceuticals, Inc. 362861077 REPACK(42254-125)
    Establishment
    Name Address ID/FEI Business Operations
    Rebel Distirbutors Corp. 118802834 RELABEL(42254-125), REPACK(42254-125)
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