Label: COLACE- docusate sodium capsule

  • NDC Code(s): 67618-101-01, 67618-101-10, 67618-101-30, 67618-101-51, view more
    67618-101-52, 67618-101-60
  • Packager: Atlantis Consumer Healthcare, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 2, 2026

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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 todo 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 over2 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 than1 week
  • PREGNANCY OR BREAST FEEDING

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

    Keep out of reach of children. In caseof overdose, get medical help or contact a Poison Control Center rightaway.



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

    adults and children 12 yearsand overtake 1-3 capsules daily
    children 2 to under 12 yearsof agetake 1 capsules daily
    children under 2 yearsask a doctor
  • STORAGE AND HANDLING

    Otherinformation

    • 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

    VALUE SIZE

    #1 DOCTOR
    RECOMMENDED
    Stool Softener Brand

    Colace®
    Docusate Sodium, 100mg

    REGULAR
    STRENGTH

    Stool Softener
    √ Gentle & Effective
    √ Relieves Constipation
    √ Cramp & Stimulant-free

    100 Capsules

    Retain this carton for
    important information.
    For added savings, visit:
    colacecapsules.com

    Dist. by: Atlantis Consumer Healthcare Inc.
    Bridgewater, NJ 08807 USA
    Questions? 1-833-288-2684
    ©2025 Atlantis Consumer Healthcare Inc.
    Colace is a registered trademark of Atlantis
    Consumer Healthcare Inc.

    A1025

    R54020

    Lot No.:
    Exp. Date:

    100 Carton

    Do not use if imprinted seal under cap is missing
    or damaged. See carton for additional information.

    A0925

    R54019

    Lot No.:

    Exp. Date:

    100 ct label

    #1 DOCTOR
    RECOMMENDED
    Stool Softener Brand

    Colace®
    Docusate Sodium, 100mg

    REGULAR
    STRENGTH

    Stool Softener
    √ Gentle, Effective Relief
    √ Cramp & Stimulant-free

    150 Capsules

    Do not use if imprinted seal under cap is missing or damaged.

    Colace is a
    registered trademark
    of Atlantis Consumer
    Healthcare Inc.

    A0125

    Dist. by: Atlantis Consumer Healthcare Inc., Bridgewater, NJ 08807 USA
    Questions? 1-833-288-2684 2025 Atlantis Consumer Healthcare Inc.
    PLD-B487B
    LB010259

    Lot No.:

    Exp. Date:

    150 count
  • 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
    6NDC:67618-101-51150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/28/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00701/30/1997
    Labeler - Atlantis Consumer Healthcare, Inc. (118983925)
    Registrant - Atlantis Consumer Healthcare, Inc. (118983925)
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