Label: DULCOLAX SOFT CHEWS BLACK CHERRY- magnesium hydroxide tablet, chewable

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated February 16, 2022

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  • SPL UNCLASSIFIED SECTION

    Dulcolax Soft Chews Saline Laxative Black Cherry

    Drug Facts

  • Active ingredient (in each chew)

    Magnesium hydroxide USP 1200 mg

  • Purpose

    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 overtake 2 to 4 chews
    children 6 to under 12 years of agetake 1 to 2 chews
    children 4 to under 6 years of agetake 1 chew (single dose or in divided doses)
    children under 4 years of ageask 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
    Black Cherry
    60 Soft chews

    Dulcolax Saline Laxative Soft Chews Black Cherry 60 Soft chews

  • INGREDIENTS AND APPEARANCE
    DULCOLAX SOFT CHEWS BLACK CHERRY 
    magnesium hydroxide tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0260
    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
    ColorredScoreno score
    ShapeRECTANGLESize35mm
    FlavorCHERRY (Black cherry) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0260-060 in 1 BAG; Type 0: Not a Combination Product03/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33403/01/2022
    Labeler - Chattem, Inc. (003336013)
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