Label: COLACE- docusate sodium capsule

  • NDC Code(s): 67618-101-01, 67618-101-10, 67618-101-30, 67618-101-52, view more
    67618-101-60
  • Packager: Avrio Health L.P.
  • 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 December 13, 2021

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

  • 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

    Avrio Health L.P.

    304996-0A

  • KEEP OUT OF REACH OF CHILDREN

  • DOSAGE & ADMINISTRATION

  • WARNINGS

  • PRINCIPAL DISPLAY PANEL

    Colace 100 mg 60 Capsules Carton

    Colace 100 mg 60 Capsules Carton
  • INGREDIENTS AND APPEARANCE
    COLACE 
    docusate sodium capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)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:67618-101-102 in 1 CARTON01/30/1997
    15 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:67618-101-301 in 1 CARTON01/30/1997
    230 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:67618-101-601 in 1 CARTON01/30/1997
    360 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    4NDC:67618-101-011 in 1 CARTON01/17/2022
    4100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    5NDC:67618-101-52250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/30/1997
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33401/30/1997
    Labeler - Avrio Health L.P. (141916531)
    Registrant - Purdue Pharma LP (932323652)
    Establishment
    NameAddressID/FEIBusiness Operations
    Patheon Softgels Inc.002193829MANUFACTURE(67618-101)
    Establishment
    NameAddressID/FEIBusiness Operations
    P&L Development, LLC079765031PACK(67618-101)