Label: COLACE- docusate sodium capsule 

  • Label RSS
  • NDC Code(s): 67618-100-30, 67618-100-60, 67618-101-10, 67618-101-30, view more
    67618-101-52, 67618-101-60
  • Packager: Purdue Products LP
  • 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 11/12

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

  • DESCRIPTION

    Drug Facts

    Colace 50 mg

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  • ACTIVE INGREDIENT

    Active ingredient (in each capsule):

    Docusate sodium 50 mg

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  • PURPOSE

    Purpose

    Stool softener

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  • WHEN USING

    Uses

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

    Warnings

    Do not use

    • if you are presently taking mineral oil, unless told to do so by a doctor
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  • ASK 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
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  • 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
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  • PREGNANCY OR BREAST FEEDING

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

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  • 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.

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  • 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 1-6
    capsules daily
    children 2 to under
    12 years of age
    take 1-3 capsules
    daily
    children under 2 years ask a doctor
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  • HOW SUPPLIED

    Other information

    • each capsule contains: sodium 3 mgVERY LOW SODIUM
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F).

    Keep tightly closed.

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  • INACTIVE INGREDIENT

    Inactive ingredients

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



    ©2012, Purdue Products L.P.
    Dist. by: Purdue Products L.P.
    Stamford, CT 06901-3431
    302525-0C







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  • DESCRIPTION

    Drug Facts

    Colace 100 mg

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  • ACTIVE INGREDIENT

    Active ingredient (in each capsule):

    Docusate sodium 100 mg

    Close
  • PURPOSE

    Purpose

    Stool softener

    Close
  • INDICATIONS & USAGE

    Uses

    • relieves occasional constipation (irregularity)
    • generally produces bowel movement in 12 to 72 hours
    Close
  • WARNINGS AND PRECAUTIONS

    Warnings

    Do not use

    • if you are presently taking mineral oil, unless told to do so by a doctor
    Close
  • ASK DOCTOR/PHARMACIST

    Ask a doctor before use if you have

    • stomach pain
    • nausea
    • vomiting
    • noticed a sudden change in bowel habits that lasts over 2 weeks
    Close
  • DO NOT 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
    Close
  • PREGNANCY OR BREAST FEEDING

    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.



    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 capsules
    daily
    children under 2 years ask a doctor
    Close
  • STORAGE AND HANDLING

    Other information

    • each capsule 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.

    Close
  • INACTIVE INGREDIENT

    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

    ©2012, Purdue Products L.P.
    Dist. by: Purdue Products L.P.
    Stamford, CT 06901-3431
    302528-0C




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  • PRINCIPAL DISPLAY PANEL

    Colace 50 mg 30 Capsules Carton

    Colace 50 mg 30 Capsules Carton
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  • PRINCIPAL DISPLAY PANEL

    Colace 100 mg 30 Capsules Carton

    Colace Carton
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  • INGREDIENTS AND APPEARANCE
    COLACE 
    docusate sodium capsule
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:67618-100
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Docusate sodium (docusate) Docusate sodium 50 mg
    Inactive Ingredients
    Ingredient Name Strength
    D&C RED NO. 33  
    FD&C RED NO. 40  
    GELATIN  
    GLYCERIN  
    POLYETHYLENE GLYCOL 400  
    PROPYLENE GLYCOL  
    SORBITOL  
    Product Characteristics
    Color RED Score no score
    Shape OVAL Size 1mm
    Flavor Imprint Code RPC;052
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:67618-100-30 1 in 1 CARTON
    1 30 in 1 BOTTLE, PLASTIC
    2 NDC:67618-100-60 1 in 1 CARTON
    2 60 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part334 01/30/1997
    COLACE 
    docusate sodium capsule
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:67618-101
    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
    D&C RED NO. 33  
    FD&C RED NO. 40  
    GELATIN  
    GLYCERIN  
    POLYETHYLENE GLYCOL 400  
    PROPYLENE GLYCOL  
    SORBITOL  
    Product Characteristics
    Color RED Score no score
    Shape OVAL Size 1mm
    Flavor Imprint Code RPC;053
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:67618-101-10 1 in 1 CARTON
    1 10 in 1 BLISTER PACK
    2 NDC:67618-101-30 1 in 1 CARTON
    2 30 in 1 BOTTLE, PLASTIC
    3 NDC:67618-101-60 1 in 1 CARTON
    3 60 in 1 BOTTLE, PLASTIC
    4 NDC:67618-101-52 250 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part334 01/30/1997
    Labeler - Purdue Products LP (141916531)
    Registrant - Purdue Pharma LP (932323652)
    Establishment
    Name Address ID/FEI Business Operations
    Catalent Pharma Solutions, LLC 051762268 MANUFACTURE(67618-101, 67618-100)
    Establishment
    Name Address ID/FEI Business Operations
    PL Developments 800014821 PACK(67618-100, 67618-101)
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