Label: INON ACE- magnesium aluminosilicates, magnesium hydroxide, simethicone tablet

  • NDC Code(s): 49873-402-01
  • Packager: Sato Pharmaceutical Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 10, 2023

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  • ACTIVE INGREDIENT

    Active ingredients (in each tablet)
    Magnesium Aluminosilicates 200 mg
    Magnesium Hydroxide 60 mg
    Simethicone 20 mg

  • PURPOSE

    Purposes
    Magnesium Aluminosilicates    Antacid
    Magnesium Hydroxide    Antacid
    Simethicone    Antigas

  • INDICATIONS & USAGE

    Uses relieves these symptoms

    ■heartburn ■acid indigestion ■sour stomach

    ■upset stomach and gas associated with these symptoms


  • WARNINGS

    Enter section text here

    Ask a doctor or pharmacist before use if you are

    ■taking a prescription drug. Antacids may interact with certain prescription drugs


    When using this product

    ■Do not take more than 9 tablets in 24-hours period or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a physician.

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

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    Directions
    ■Adults and children 12 years of age and over: Take 3 tablets with water 3 times daily between meals and at bedtime, or as directed by a doctor.
    ■Children under 12 years: Ask a doctor.

  • OTHER SAFETY INFORMATION

    Other information  
    ■Each tablet contains: sodium 8 mg, magnesium 35 mg
    ■Do not purchase if printed seal with “sato” is broken or missing from top or bottom of carton.

  • INACTIVE INGREDIENT

    Inactive ingredients  caramel, colloidal silicon dioxide, croscarmellose sodium, flavor, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, synthetic iron oxide

  • PRINCIPAL DISPLAY PANEL

    carton

  • INGREDIENTS AND APPEARANCE
    INON ACE 
    magnesium aluminosilicates, magnesium hydroxide, simethicone tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49873-402
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE60 mg
    SILODRATE (UNII: 9T3UU8T0QK) (SILODRATE - UNII:9T3UU8T0QK) SILODRATE200 mg
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE20 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARAMEL (UNII: T9D99G2B1R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Product Characteristics
    Colorbrown (pale brown) Scoreno score
    ShapeROUNDSize9mm
    FlavorPEPPERMINT, GINGER (ginger extract) , CINNAMON (cinnamon oil) , ANISE (fennel) Imprint Code SATO;6
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49873-402-011 in 1 CARTON11/01/1995
    175 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00111/01/1995
    Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sato Pharmaceutical Co., Ltd.715699133manufacture(49873-402) , label(49873-402) , pack(49873-402)
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