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

  • Label RSS
  • NDC Code(s): 0536-3756-01, 0536-3756-10
  • Packager: Rugby Laboratories Inc
  • 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 04/13

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

  • Active ingredient (in each softgel)

    Docusate Sodium 100 mg

    Purpose

    Stool softener

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  • Uses

    • for 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 longer than 1 week, unless directed by a doctor 

    Ask a doctor before use if

    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 care 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 of age  take 1 to 3 softgels preferably at bedtime
     children 6-12 years of age  take 1 softgel at bedtime
     children under 6 years  ask a doctor
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  • Other information

    • each softgel contains: sodium 6 mg
    • store between 15º-30ºC (59º-86ºF)
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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

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  • Principal Display Panel

    COMPARE TO ACTIVE INGREDIENT IN COLACE®*

    NON-HABIT FORMING

    Stool Softener Laxative

    Docusate Sodium USP, 100 mg

    SOFTGEL CAPSULES

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    *Rugby Laboratories is not affiliated with the owner of the trademark Colace®.

    Distributed by: Rugby Laboratories

    31778 Enterprise Drive

    Livonia, MI  48150

    www.rugbylaboratories.com

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  • Product Label

    Docusate Sodium 100 mg

    Rugby Stool Softener Laxative Softgel

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  • 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: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:0536-3756-01 100 in 1 BOTTLE
    2 NDC:0536-3756-10 1000 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 - Rugby Laboratories Inc (191427277)
    Registrant - P and L Development of New York Corporation (800014821)
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