Label: COLACE- docusate sodium capsule, liquid filled

  • NDC Code(s): 67618-111-28, 67618-111-42, 67618-111-60
  • Packager: Atlantis Consumer Healthcare, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 10, 2024

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  • ACTIVE INGREDIENT

    Drug Facts

  • PURPOSE

    Active ingredientPurpose
    (in each soft gel) 
    Docusate sodium 50 mg...........Stool softener
  • INDICATIONS & USAGE

    Uses

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

  • DO NOT USE

    Warnings

    Do not use

    • if you are presently taking mineral oil, unless told to do so by a doctor
  • 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
  • STOP USE

    Stop use and ask a doctor if

    • you have rectal bleeding or fail to have a bowel movementafter 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

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • DOSAGE FORMS & STRENGTHS

    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
  • HOW SUPPLIED

    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.

  • INACTIVE INGREDIENT

    Inactive ingredients
    gelatin, glycerin, PEG 400, propylene glycol, sorbitol

    Soft gels are imprinted with edible dye-free ink.

    Dist. by: Atlantis Consumer Healthcare Inc.
    Bridgewater, NJ 08807

    Questions? 1-833-288-2684

    ©2023 Atlantis Consumer Healthcare Inc.
    Colace is a registered trademark of Atlantis Consumer Healthcare Inc.

  • DOSAGE & ADMINISTRATION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    #1 DOCTOR
    RECOMMENDED
    Stool Softener Brand

    Colace
    Docusate Sodium, 50mg
    CLEAR

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

    28 Clear Soft Gels

    304999-0B

    Front Panel
    #1 DOCTOR
    RECOMMENDED
    Stool Softener Brand

    Colace®
    Docusate Sodium, 50mg

    CLEAR

    Stool Softener

    √ Gentle, Effective
       Constipation Relief
    √ Stimulant-Free & Dye-Free 

    42 Clear Soft Gels

    Side Panel

    Colace®
    Docusate Sodium, 50mg

    √ Dye & Preservative-Free
    √ Stimulant-Free
    √ No Artificial Sweeteners
    √ Non-GMO

    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
    ©2023 Atlantis Consumer Healthcare Inc.
    Colace is a registered trademark of Atlantis
    Consumer Healthcare Inc.

    Lot No.:

    Exp. Date:

    A0923

    42 count carton

    Front Panel
    #1 DOCTOR
    RECOMMENDED
    Stool Softener Brand

    Colace®
    Docusate Sodium, 50mg

    CLEAR

    Stool Softener

    √ Gentle, Effective
       Constipation Relief
    √ Stimulant-Free & Dye-Free 

    60 Clear Soft Gels

    Side Panel

    Colace®
    Docusate Sodium, 50mg

    √ Dye & Preservative-Free
    √ Stimulant-Free
    √ No Artificial Sweeteners
    √ Non-GMO

    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
    ©2023 Atlantis Consumer Healthcare Inc.
    Colace is a registered trademark of Atlantis
    Consumer Healthcare Inc.

    Lot No.:

    Exp. Date:

    A1123

    60 count carton
  • INGREDIENTS AND APPEARANCE
    COLACE 
    docusate sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67618-111
    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, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorBROWN (clear to light brown) Scoreno score
    ShapeOVALSize11mm
    FlavorImprint Code CLR;50
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67618-111-281 in 1 CARTON01/07/1900
    128 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:67618-111-421 in 1 CARTON02/01/2024
    242 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:67618-111-601 in 1 CARTON04/01/2024
    360 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00701/07/1900
    Labeler - Atlantis Consumer Healthcare, Inc. (118983925)
    Registrant - Atlantis Consumer Healthcare, Inc. (118983925)
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