Label: MINTOX MAXIMUM STRENGTH- aluminum hydroxide, magnesium hydroxide, dimethicone suspension

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 30, 2024

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  • Active ingredients (in each 5 mL teaspoonful)

    Aluminum hydroxide 400 mg (equivalent to dried gel, USP)

    Magnesium hydroxide 400 mg

    Simethicone 40mg

  • Purposes

    Antacid

    Antigas

  • Uses

    relieves

    • heartburn
    • sour stomach
    • acid indigestion
    • the symptoms referred to as gas
  • Warnings

    Ask a doctor before use if you have

    • kidney disease

    • a magnesium-restricted diet

    taking a prescription drug. Ask a doctor or pharmacist before use if you are

    Antacids may interact with certain prescription drugs.

    symptoms last more than 2 weeks Stop use and ask a doctor if

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

    Keep out of reach of children.

  • Directions

    • shake well before use

    • do not take more than 8 teaspoonfuls in 24 hours or use the maximum dosage for more than 2 weeks

    • adults and children 12 years and older: take 2 to 4 teaspoonfuls two times a day, or as directed by a doctor

    • children under 12 years: ask a doctor

  • Other information

    • magnesium 165 mg, sodium 1 mg each 5 mL teaspoonful contains:

    • store at room temperature

    • protect from freezing

     • keep tightly closed

    • TAMPER-EVIDENT: Do not use if breakaway band on bottle cap is missing or broken.

  • Inactive ingredients

    benzyl alcohol, butylparaben, caramel color, carboxymethylcellulose sodium, D and C yellow no.10,  flavor, glycerin, hypromellose, microcrystalline cellulose, propylparaben, purified water, saccharin sodium, sorbitol solution

  • MINTOX MAXIMUM STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION

    image description

  • INGREDIENTS AND APPEARANCE
    MINTOX MAXIMUM STRENGTH  
    aluminum hydroxide, magnesium hydroxide, dimethicone suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-5725(NDC:0904-5725)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE400 mg  in 5 mL
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE400 mg  in 5 mL
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE40 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorLEMON (lemon) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17856-5725-115 mL in 1 CUP; Type 0: Not a Combination Product01/28/2021
    2NDC:17856-5725-330 mL in 1 CUP; Type 0: Not a Combination Product01/28/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02/01/2011
    Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)
    Establishment
    NameAddressID/FEIBusiness Operations
    UNIT DOSE SOLUTIONS360804194REPACK(17856-5725)
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