Label: COLACE CLEAR- 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 28, 2015

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  • Drug Facts

    Colace Clear 50 mg

    Active ingredient
    (in each soft gel)

    Docusate sodium 50 mg

  • INDICATIONS & USAGE

  • Purpose

    Stool softener

  • Uses

    • relieves occasional constipation (irregularity)
    • generally produces 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 habits that lasts over 2 weeks
  • 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 overtake 1-6 soft gels daily
    children 2 to under 12 years of agetake 1-3 soft gels daily
    children under 2 yearsask a doctor
  • QUESTIONS

    Other information

    • each soft gel contains: sodium 3 mg VERY LOW SODIUM
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F).
      Keep tightly closed.
  • HOW SUPPLIED

  • Inactive ingredients

    gelatin,glycerin, PEG 400, propylene glycol, sorbitol

    Soft gels are imprinted with edible dye-free ink.

    ©2014, Purdue Products L.P.
    Dist. by: Purdue Products L.P.
    Stamford, CT 06901-3431
    Made in the USA
    303458-0A

  • PRINCIPAL DISPLAY PANEL

    Colace Clear™ 50 mg Carton
    NDC: 67818-100-28

    Colace Clear 50mg
  • INGREDIENTS AND APPEARANCE
    COLACE CLEAR 
    docusate sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67618-109
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
    Inactive Ingredients
    Ingredient NameStrength
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorBROWN (Clear to light brown) Score2 pieces
    ShapeOVALSize11mm
    FlavorImprint Code CLR;50
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67618-109-281 in 1 CARTON
    128 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33412/16/2014
    Labeler - Purdue Products LP (141916531)
    Registrant - Purdue Pharma LP (932323652)
    Establishment
    NameAddressID/FEIBusiness Operations
    Catalent Pharma Solutions, LLC051762268MANUFACTURE(67618-109)
    Establishment
    NameAddressID/FEIBusiness Operations
    PL Developments800014821PACK(67618-109)
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