Label: COLACE- docusate sodium capsule

  • 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 5, 2022

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  • DESCRIPTION

    Drug Facts

    Colace 100 mg

  • ACTIVE INGREDIENT

    Active ingredient (in each capsule):

    Docusate sodium 100 mg

  • PURPOSE

    Purpose

    Stool softener

  • INDICATIONS & USAGE

    Uses

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

    Warnings

    Do not use

    • if you are presently taking mineral oil, unless told to do so by a doctor
  • 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
  • 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
  • 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 overtake 1-3 capsules daily
    children 2 to under 12 years of agetake 1 capsules daily
    children under 2 yearsask a doctor
  • 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.

  • INACTIVE INGREDIENT

    Inactive ingredients

    D&C Red No. 33, FD&C Blue #1, FD&C Red No. 40,

    FD&C Yellow No. 6, gelatin, glycerin, PEG

    400, propylene glycol, sorbitol, titanium

    dioxide

    Repackaged and Distributed By:

    Remedy Repack, Inc.

    625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

  • KEEP OUT OF REACH OF CHILDREN

  • DOSAGE & ADMINISTRATION

  • WARNINGS

  • PRINCIPAL DISPLAY PANEL

    DRUG: Colace

    GENERIC: Docusate sodium

    DOSAGE: CAPSULE

    ADMINSTRATION: ORAL

    NDC: 70518-3319-0

    COLOR: red

    SHAPE: OVAL

    SCORE: No score

    SIZE: 12 mm

    IMPRINT: RPC;053

    PACKAGING: 30 in 1 BLISTER PACK

    ACTIVE INGREDIENT(S):

    • Docusate sodium 100mg in 1

    INACTIVE INGREDIENT(S):

    • D&C RED NO. 33
    • FD&C RED NO. 40
    • GELATIN
    • GLYCERIN
    • POLYETHYLENE GLYCOL 400
    • PROPYLENE GLYCOL
    • SORBITOL
    • FD&C BLUE NO. 1
    • FD&C YELLOW NO. 6
    • TITANIUM DIOXIDE

    Remedy_Label

  • INGREDIENTS AND APPEARANCE
    COLACE 
    docusate sodium capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-3319(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)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL (UNII: 506T60A25R)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorred, whiteScoreno score
    ShapeOVALSize12mm
    FlavorImprint Code RPC;053
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70518-3319-030 in 1 BLISTER PACK; Type 0: Not a Combination Product12/29/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33412/29/2021
    Labeler - REMEDYREPACK INC. (829572556)
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