Label: COLACE- docusate sodium - sennosides tablet, film coated

  • NDC Code(s): 67618-110-10, 67618-110-30, 67618-110-60
  • Packager: Atlantis Consumer Healthcare, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 18, 2023

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  • ACTIVE INGREDIENT

    Drug Facts

    Active ingredientPurpose
    Docusate sodium 50 mg Stool softener
    Sennosides 8.6 mg Stimulant laxative
  • PURPOSE

  • INDICATIONS & USAGE

    Uses

    • relieves occasional constipation (irregularity)
    • generally produces bowel movement in 6 to 12 hours
  • WARNINGS

  • DO NOT USE

    Warnings

    Do not use

    • laxative products for longer than 1 week unless told to do so by a doctor
    • 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 movement after use of a laxative. These could be signs of a serious condition.

  • 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 & ADMINISTRATION

    Directions

    • Take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses.
    adults and children 12 years and overtake 2-4 tablets daily
    children 6 to under 12 years of agetake 1-2 tablets daily
    children 2 to under 6 years of agetake up to 1 tablet daily
    children under 2ask a doctor
  • HOW SUPPLIED

    Other information

    • each tablet contains: calcium 7 mg, sodium 4 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

    croscarmellose sodium, dicalcium phosphate, FD&C Blue #1 Lake, FD&C Red #40 Lake, FD&C Yellow #6 Lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, polyethylene glycol, sodium benzoate, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide, triacetin.

    Dist. by: Atlantis Consumer Healthcare inc.
    Bridgewater, NJ 08801 USA
    Questions? 1-833-286-2684
    ©2023 Atlantis Consumer Healthcare inc.
    Colace is a registered trademark of Atlantis
    Consumer Healthcare Inc.

    A1023

    R52504

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    #1
    DOCTOR
    RECOMMENDED
    Stool Softener Brand

    Colace®

    Docusate Sodium, 50 mg   
    Sennosides 8.6 mg

    2-IN-1

    Stool Softener +
    Stimulant Laxative
    √ Gentle, Effective, & Dependable
    √ Constipation Relief in 6 `12 hours

    10 Tablets

    10 count carton

    Colace® 2-IN-1 Tablets
    Docusate Sodium
    Sennosides
    Dist. by: Atlantis Consumer
    Healthcare Inc.

    LOT XXXXXX
    EXP YYYY-MM

    10 count blister

    #1
    DOCTOR
    RECOMMENDED
    Stool Softener Brand

    Colace®

    Docusate Sodium, 50 mg   
    Sennosides 8.6 mg

    2-IN-1

    Stool Softener +
    Stimulant Laxative
    √ Gentle, Effective, & Dependable
    √ Constipation Relief in 6 `12 hours

    30 Tablets

    Retain this carton for
    Important information 

    Dist. by: Atlantis Consumer Healthcare inc.
    Bridgewater, NJ 08801 USA
    Questions? 1-833-286-2684
    ©2023 Atlantis Consumer Healthcare inc.
    Colace is a registered trademark of Atlantis
    Consumer Healthcare Inc.

     
    A1023

    R52506

    30 count carton

    Colace®

    Docusate Sodium
    Sennosides

    2-IN-1

    Stool Softener +
    Stimulant Laxative
    30 Tablets

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

    Dist. by: Atlantis Consumer Healthcare inc.
    Bridgewater, NJ 08801 USA
    Questions? 1-833-286-2684
    ©2023 Atlantis Consumer Healthcare inc.
    Colace is a registered trademark of Atlantis
    Consumer Healthcare Inc.

    A1023

    R52507

    30 count lable

    #1
    DOCTOR
    RECOMMENDED
    Stool Softener Brand

    Colace®

    Docusate Sodium, 50 mg   
    Sennosides 8.6 mg

    2-IN-1

    Stool Softener +
    Stimulant Laxative
    √ Gentle, Effective, & Dependable
    √ Constipation Relief in 6 `12 hours

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

    Dist. by: Atlantis Consumer Healthcare inc.
    Bridgewater, NJ 08801 USA
    Questions? 1-833-286-2684
    ©2023 Atlantis Consumer Healthcare inc.
    Colace is a registered trademark of Atlantis
    Consumer Healthcare Inc.

    A1023

    R52508
    60 Tablets

    A1023

    R52507

    60 count carton

    Colace®

    Docusate Sodium
    Sennosides

    2-IN-1

    Stool Softener +
    Stimulant Laxative
    60 Tablets

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

    Dist. by: Atlantis Consumer Healthcare inc.
    Bridgewater, NJ 08801 USA
    Questions? 1-833-286-2684
    ©2023 Atlantis Consumer Healthcare inc.
    Colace is a registered trademark of Atlantis
    Consumer Healthcare Inc.

    LOT:

    EXP:

    A1023

    R52509

    60 count lable
  • INGREDIENTS AND APPEARANCE
    COLACE 
    docusate sodium - sennosides tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67618-110
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
    SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorRED (burgundy) Scoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code P;054
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67618-110-102 in 1 CARTON02/08/1957
    15 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:67618-110-301 in 1 CARTON02/08/1957
    230 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:67618-110-601 in 1 CARTON02/08/1957
    360 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00702/08/1957
    Labeler - Atlantis Consumer Healthcare, Inc. (118983925)
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