Label: COLACE- docusate sodium capsule

  • 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 March 29, 2010

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  • Drug Facts Colace 100 mg Active ingredient (in each capsule)

    Docusate sodium 100 mg

  • Purpose

    Stool softener

  • Uses

    • relieves occasional constipation (irregularity)
    • generally produces a bowel movement in 12 to 72 hours
  • Warnings

  • Do not use

    • if you are presently taking mineral oil, unless told to do so by a doctor
  • Ask a doctor before use if you have

    • stomach pain
    • nausea
    • vomiting
    • noticed a sudden change in bowel movements that continues over a period of 2 weeks
  • STOP USE

    Stop use and ask a doctor if

    • you have rectal bleeding or fail to have a bowel movement after use of a laxative.
      These could be signs of a serious condition.
    • you need to use a stool softener laxative for more than 1 week
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions: Take only by mouth. Doses may be taken as a single daily dose or in divided doses.

    adults and children
    12 years and over     		take 1-3
    capsules daily
    children 2 to under
    12 years of age     		take 1
    capsule daily
    children under 2 yearsask a doctor
  • Other Information

    • each tablet contains: sodium 5 mg
      VERY LOW SODIUM
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

    Keep tightly closed.

  • Inactive ingredients

    D&C Red No. 33, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, PEG 400, propylene glycol, sorbitol, titanium dioxide

  • SPL UNCLASSIFIED SECTION

    ©2009 Purdue Products L.P.

    Dist. by: Purdue Products L.P.
    Stamford, CT 06901-3431

    302112-0B

    Additional bar code label applied by:
    Physicians Total Care, Inc.
    Tulsa, Oklahoma      74146

  • PRINCIPAL DISPLAY PANEL

    Colace

    100mg

    NDC 54868-2337-2

    30 capsules

    Colace Docusate Sodium 100mg

  • INGREDIENTS AND APPEARANCE
    COLACE 
    docusate sodium capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-2337(NDC:67618-101)
    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
    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 glycol 400 (UNII: B697894SGQ)  
    propylene glycol (UNII: 6DC9Q167V3)  
    sorbitol (UNII: 506T60A25R)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorRED (Two-toned- opaque light beige and clear red) Scoreno score
    ShapeOVALSize1mm
    FlavorImprint Code RPC;053
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54868-2337-21 in 1 CARTON
    130 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33411/08/2011
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Physicians Total Care, Inc.194123980relabel
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