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

  • NDC Code(s): 0904-5725-14
  • Packager: MAJOR Pharmaceuticals Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 2, 2023

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

  • 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

    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 using
    • adults and children 12 years and older: take 2 to 4 teaspoonfuls two times a day or as directed by a physician
    • do not take more than 8 teaspoonfuls in 24 hours or use the maximum dosage for more than 2 weeks.
    • children under 12 years: consult a physician

  • Other information

    • each 5 mL teaspoonful contains: magnesium 165 mg, sodium 5 mg
    • keep tightly closed
    • store at room temperature and avoid freezing
  • 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

  • package Label

    NDC 0904-5725-14

    MAJOR

    Mintox

    Maximum Strength

    antacid/antigas

    Alumina, Magnesia and Simethicone Oral Suspension USP

    Fast Relief of:

    HEARTBURN

    ACID INDIGESTION

    PRESSURE AND BLOATING

    Lemon Creme

    *compare to the active ingredients of Maalox Advanced Maximum Strength

    12 FL OZ (355 mL)

    AJ

  • INGREDIENTS AND APPEARANCE
    MINTOX MAXIMUM STRENGTH 
    aluminum hydroxide, magnesium hydroxide, dimethicone suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)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
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    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:0904-5725-14355 mL in 1 BOTTLE; Type 0: Not a Combination Product11/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00102/01/2011
    Labeler - MAJOR Pharmaceuticals Inc. (191427277)
    Registrant - GCP Laboratories (965480861)
    Establishment
    NameAddressID/FEIBusiness Operations
    GCP Laboratories965480861manufacture(0904-5725)