Label: INON ACE- silodrate and magnesium hydroxide solution 

  • Label RSS
  • NDC Code(s): 49873-403-01
  • Packager: Sato Pharmaceutical Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 03/13

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  • ACTIVE INGREDIENT

    Active ingredients (in each bottle)
    Magnesium Aluminosilicate 900 mg
    Magnesium Hydroxide 250 mg

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  • PURPOSE

    Purpose
    Magnesium Aluminosilicate     Antacid
    Magnesium Hydroxide     Antacid

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  • INDICATIONS & USAGE

    Uses relieves these symptoms:
    ■ heartburn    ■ sour stomach    ■ acid indigestion

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  • WARNINGS

    Warnings

    Do not use this product if you are taking a prescription antibiotic drug containing any
    form of tetracycline.

    Ask a doctor or pharmacist before use if you are presently taking a prescription drug.
    Antacids may interact with certain prescription drugs.

    When using this product
    ■ Do not take more than 2 bottles (adults and children 12 years and over) in a 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.
    ■ May have laxative effect.

    Keep out of reach of children.

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  • DOSAGE & ADMINISTRATION

    Directions
    ■ Adults and children 12 years and over: Take 1 bottle (30mL) at a time 2 times daily,    
        between meals, or as directed by a doctor.
    ■ Children under 12 years: Ask a doctor.
    ■ Shake well before use.

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  • OTHER SAFETY INFORMATION

    Other information
    ■ Each bottle contains: sodium 15 mg, magnesium 165 mg

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  • INACTIVE INGREDIENT

    Inactive ingredients  alcohol, butylparaben, citric acid, flavors (cinnamon oil, fluid
    extract of ginger root, spearmint oil), hydroxypropylstarch, PEG-60 hydrogenated castor
    oil, propylparaben, sodium benzoate, sodium citrate, sorbitol, water.

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  • PDP
  • Carton
  • INGREDIENTS AND APPEARANCE
    INON ACE 
    magnesium aluminosilicate, magnesium hydroxide solution
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49873-403
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SILODRATE (SILODRATE) SILODRATE 900 mg  in 30 mL
    MAGNESIUM HYDROXIDE (MAGNESIUM CATION) MAGNESIUM HYDROXIDE 250 mg  in 30 mL
    Inactive Ingredients
    Ingredient Name Strength
    ALCOHOL  
    BUTYLPARABEN  
    CITRIC ACID MONOHYDRATE  
    HYDROXYPROPYL CORN STARCH (5% SUBSTITUTION BY WEIGHT)  
    POLYOXYL 60 HYDROGENATED CASTOR OIL  
    PROPYLPARABEN  
    SODIUM BENZOATE  
    SODIUM CITRATE  
    SORBITOL  
    WATER  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor CINNAMON (CINNAMON OIL) , MINT (MENTHA OIL) , GINGER (GINGER, LIQUID EXTRACT) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49873-403-01 2 in 1 CARTON
    1 30 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part331 05/20/2000
    Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
    Establishment
    Name Address ID/FEI Business Operations
    Sato Pharmaceutical Co., Ltd. 715699133 manufacture(49873-403), label(49873-403), pack(49873-403)
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