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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 September 1, 2021

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  • Active ingredients (in each 5 mL teaspoonful)

    Aluminum hydroxide 200 mg (equivalent to dried gel, USP)

    Magnesium hydroxide 200 mg

    Simethicone 20mg

  • Purposes

    Antacid

    Antigas

  • Uses

    relieves

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

    Ask a doctor before use if you have

    • kidney disease

    • a magnesium-restricted diet


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

    Antacids may interact with certain prescription drugs.

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

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

    Keep out of reach of children.

  • Directions

    • shake well before use
    • adults and children 12 years of age and older: take 2 to 4 teaspoonfuls between meals, at bedtime, or as directed by a doctor
    • do not take more than 16 teaspoonfuls in 24 hours or use the maximum dosage for more than 2 weeks
    • children under 12 years: ask a doctor

  • Other information

    • each 5 mL teaspoonful contains: magnesium 85 mg, sodium 3 mg
    • store at room temperature and avoid freezing
    • keep tightly closed
  • Inactive ingredients

    benzyl alcohol, butylparaben, carboxymethylcellulose sodium, flavor, hypromellose, microcrystalline cellulose, propylparaben, purified water, saccharin sodium, sorbitol solution

  • HOW SUPPLIED

    Product: 50090-1538

    NDC: 50090-1538-0 355 mL in a BOTTLE

  • aluminum hydroxide, magnesium hydroxide, dimethicone

    Label Image
  • INGREDIENTS AND APPEARANCE
    MINTOX 
    aluminum hydroxide, magnesium hydroxide, dimethicone suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-1538(NDC:0904-5721)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE200 mg  in 5 mL
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE200 mg  in 5 mL
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE20 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50090-1538-0355 mL in 1 BOTTLE; Type 0: Not a Combination Product12/16/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33102/01/2011
    Labeler - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-1538)
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