Label: DULCOLAX SOFT CHEWS MIXED BERRY- magnesium hydroxide tablet, chewable

  • NDC Code(s): 41167-0265-3, 41167-0265-6, 41167-0265-8
  • Packager: Chattem, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 3, 2023

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  • SPL UNCLASSIFIED SECTION

    Dulcolax® Soft Chews Saline Laxative – Mixed Berry

    Drug Facts

  • Active ingredient (in each chew)

  • Purpose

    Magnesium hydroxide 1200 mg................................................................................................Saline laxative

  • Use

    ● for relief of occasional constipation (irregularity)

    ● this product generally produces bowel movement in ½ to 6 hours

  • Warnings

    Ask a doctor before use if you have

    ● kidney disease  ● a magnesium-restricted diet

    ● stomach pain, nausea or vomiting ● noticed a sudden change in bowel habits that lasts over 2 weeks

    Ask a doctor or pharmacist before use if you are

    taking a prescription drug. This product may interact with certain prescription drugs.

    Stop use and ask a doctor if

    ● you have rectal bleeding or fail to have a bowel movement after using this product. These could be signs of a serious condition. ● you need to use a laxative for more than 1 week

    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

    ● drink a full glass (8 oz) of liquid with each dose

    ● dose may be taken as a single daily dose or in divided doses

    ● do not exceed the maximum recommended daily dose in a 24 hour period

    adults and children 12 years of age and over2 to 4 chews
    children 6 to under 12 years of age 1 to 2 chews
    children under 6 years of age ask a doctor
  • Other information

    ● each chew contains: magnesium 500 mg, sodium 2 mg

    ● store at room temperature 20°-25°C (68°-77°F)

  • Inactive ingredients

    corn syrup, FD&C red no. 40, glycerin, hydrogenated coconut oil, lecithin (soy), natural flavor, sucrose, water

  • Questions?

    Call 1-866-844-2798 or visit www.Dulcolax.com

  • PRINCIPAL DISPLAY PANEL

    Dulcolax
    Saline Laxative
    Soft
    Chews
    Mixed Berry
    30 Soft chews

    PRINCIPAL DISPLAY PANEL Dulcolax Saline Laxative Soft Chews Mixed Berry 30 Soft chews

  • INGREDIENTS AND APPEARANCE
    DULCOLAX SOFT CHEWS MIXED BERRY 
    magnesium hydroxide tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0265
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE1200 mg
    Inactive Ingredients
    Ingredient NameStrength
    CORN SYRUP (UNII: 9G5L16BK6N)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeRECTANGLESize25mm
    FlavorBERRY (Mixed Berry) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0265-330 in 1 BAG; Type 0: Not a Combination Product02/23/2020
    2NDC:41167-0265-660 in 1 BAG; Type 0: Not a Combination Product02/23/2020
    3NDC:41167-0265-815 in 1 BAG; Type 0: Not a Combination Product01/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)02/23/2020
    Labeler - Chattem, Inc. (003336013)
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