Label: EXTRA STRENGTH STOOL SOFTENER LAXATIVE- docusate sodium capsule, liquid filled 

  • Label RSS
  • 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 09/14

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

  • Active Ingredient (in each softgel)

    Docusate Sodium 250 mg

    Purpose

    Stool softener

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  • Uses

    for the prevention of dry, hard stools
    for relief of occasional constipation
    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 more than 1 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 2 weeks.

    Stop use and ask a doctor if

    you have rectal bleeding
    you fail to have a bowel movement after use

    These could be signs of a serious condition.

    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.

    This package is intended for in-patient institutional use only.

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  • Directions

    adults and children 12 years of age and over: take1 softgel daily or as directed by a doctor
    children under 12 years of age: take as directed by a doctor
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  • Other information

    each softgel contains: sodium 15 mg

    store between 15º-30ºC (59º-86ºF)
    See window for lot number and expiration date
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  • Inactive Ingredients

    edible white ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special

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  • Questions or comments?

    1-800-645-2158

    Extra Strength Stool Softener Laxative
    Docusate Sodium USP, 250 mg

    SOFTGEL CAPSULES

    Distributed by: Rugby Laboratories

    31778 Enterprise Drive

    Livonia, MI  48150
    www.rugbylaboratories.com

    Rugby is trademark of its respective owner.

    Repackaged by: Cardinal Health

    Zanesville, OH 43701

    LUC4600029-10114

    LUC4600029-20114

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  • Principal Display Panel

    Stool Softener

    (docusate sodium USP)

    250 mg

    pouch
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  • Principal Display Panel

    Stool Softener

    (docusate sodium USP)

    250 mg

    100 Softgel Capsules

    Bag Label
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  • Principal Display Panel

    Stool Softener

    Laxative

    Docusate Sodium USP, 250 mg

    10 SOFTGEL CAPSULES

    Bag Label

     

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  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH STOOL SOFTENER LAXATIVE 
    docusate sodium capsule, liquid filled
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55154-6812(NDC:0536-3757)
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 250 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 20mm
    Flavor Imprint Code P20
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55154-6812-4 100 in 1 CARTON
    1 NDC:55154-6812-6 1 in 1 POUCH; Combination Product Type = C112160
    2 NDC:55154-6812-0 10 in 1 BAG
    2 1 in 1 POUCH; Combination Product Type = C112160
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part334 03/29/2012
    Labeler - Cardinal Health (188557102)
    Establishment
    Name Address ID/FEI Business Operations
    Cardinal Health 188557102 REPACK(55154-6812)
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