Label: DULCOLAX CHEWY BITES ASSORTED FRUITS- 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 June 7, 2022

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Dulcolax Chewy Fruit Bites Saline Laxative

    Drug Facts

  • Active ingredient (in each chew)

  • Purpose

    Magnesium hydroxide USP 600 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 and over4 chews (Up to 8 chews)
    children 6 to under 12 years2 chews (Up to 4 chews)
    children under 6 yearsask a doctor
  • Other information

    ● each chew contains: magnesium 250 mg, sodium 1 mg

    ● contains FD&C yellow no. 5 (tartrazine) as a color additive

    ● contains FD&C yellow no. 6

    ● store at 20°-25°C (68°-77°F)

  • Inactive ingredients

    ammonium hydroxide, carnauba wax, corn syrup, ethanol, ethyl acetate, FD&C blue no. 1, FD&C red no. 40, FD&C red no. 40 aluminum lake, FD&C yellow no. 5, FD&C yellow no. 5 aluminum lake, FD&C yellow no. 6, gum arabic, hydrogenated coconut oil, isopropanol, lecithin (soy), natural and artificial flavors, n-butanol, phosphoric acid, propylene glycol, shellac, sodium benzoate, sorbitol, sucrose, titanium dioxide, water, white beeswax

  • Questions?

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

  • PRINCIPAL DISPLAY PANEL

    Dulcolax
    Chewy fruit bites
    30 Chewable bites
    Assorted fruit

    PRINCIPAL DISPLAY PANEL
Dulcolax
Chewy fruit bites
30 Chewable bites
Assorted fruit

    PRINCIPAL DISPLAY PANEL
Dulcolax
Chewy fruit bites
30 Chewable bites
Assorted fruit

    PRINCIPAL DISPLAY PANEL
Dulcolax
Chewy fruit bites
30 Chewable bites
Assorted fruit

  • INGREDIENTS AND APPEARANCE
    DULCOLAX CHEWY BITES ASSORTED FRUITS 
    magnesium hydroxide tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0256
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE600 mg
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIA (UNII: 5138Q19F1X)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    ALCOHOL (UNII: 3K9958V90M)  
    ETHYL ACETATE (UNII: 76845O8NMZ)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    ACACIA (UNII: 5C5403N26O)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C YELLOW NO. 5 ALUMINUM LAKE (UNII: JQ6BLH9FR7)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCROSE (UNII: C151H8M554)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    Colororange, yellow, pinkScoreno score
    ShapeROUND (Ellipsoid) Size13mm
    FlavorFRUIT (Lemon, Orange, Strawberry) Imprint Code D
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0256-030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/06/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33406/06/2022
    Labeler - Chattem, Inc. (003336013)