Label: COLACE EXTRA STRENGTH STOOL SOFTNER- docusate sodium capsule, liquid filled

  • NDC Code(s): 67618-201-60
  • Packager: Atlantis Consumer Healthcare Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 4, 2024

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  • Drug Facts

  • Active ingredient (in each softgel)

    Docusate Sodium 250 mg

  • Purpose

    Stool softener

  • Uses

    • relieves occasional constipation (irregularity)
      • generally produces a bowel movement within 12 to 72 hours.
  • Warnings

    Do not useif you are presently taking mineral oil, unless told to do so by a 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 and ask a doctor if

    • you have rectal bleeding or fail to have a bowel movement after use of a laxative.
      These can be signs of a serious condition
    • you need to use a stool softner laxative for more than 1 week

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

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    adults and children 12 years of age and older

    take 1 softgel daily or as directed by a doctor.

    children under 12 years of age

    ask a doctor
  • Other information

    • each softgel contains:sodium 15mg
    • store at 20-25°C (68-77°F).
    • Keep carton for full product information
  • Inactive ingredients

    gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol. Softgels are imprinted with edible, dye-free ink.

  • Questions? 

    1-833-288-2684

  • Principal Display Panel

    EXTRA STRENGTH

    #1 DOCTOR RECOMMENDED

    Stool Softner Brand

    COLACE

    Docusate Sodium, 250mg

    EXTRA STRENGTH

    Stool Softner

    √Gentle & Effective

    √Relieves Constipation

    √Cramp & Stimulant-Free

    √Dye & Preservative-Free √

    60 Clear Soft Gels

    Retain this carton for important information.

    Dis. By: Atlantis Consumer Healthcare Inc.

    Bridgewater, NJ 08807 USA

    Questions? 1-833-288-2684

    ©2024 Atlantis Consumer Healthcare Inc.

    Colace is a registered trademark of Atlantis Consumer Healthcare Inc.

    A0824

    Colace Extra strength 250mg 60 softgels
  • INGREDIENTS AND APPEARANCE
    COLACE EXTRA STRENGTH   STOOL SOFTNER
    docusate sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67618-201
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM250 mg
    Inactive Ingredients
    Ingredient NameStrength
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize12mm
    FlavorImprint Code C250
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67618-201-6060 in 1 BOTTLE; Type 0: Not a Combination Product08/05/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00708/05/2024
    Labeler - Atlantis Consumer Healthcare Inc. (118983925)
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