Label: MAGNESIUM HYDROXIDE/ALUMINUM HYDROXICE/SIMETHICONE- magnesium hydroxide,aluminum hydroxice,simethicone suspension

  • Category: HUMAN OTC DRUG LABEL

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 March 25, 2022

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  • Active Ingredient

    Each 30 mL Contains: Purpose

     
    Aluminum hydroxide (equiv. to dried gel, USP) 2400 mg Antacid
     
    Magnesium hydroxide USP 2400 mg Antacid
     
    Simethicone Max 240 mg Antigas

    Delivers 30 mL

    Shake Well

    See Insert

    Sugar Free - Dye Free - Alcohol Free
    each 30 mL contains: calcium 40 mg, sodium 25 mg, and magnesium 1000 mg
  • Purpose

    Antacid / Antigas

  • Indications and Usage

    Uses

    - acid indigestion

    - heartburn

    - sour stomach

    - upset stomach due to these symptoms

    - pressure and bloating commonly referred to as gas

  • Ask Doctor

    Ask a doctor before use if you have

    - kidney disease

    - a magnesium-restricted diet

    Stop use and ask a doctor if

    - you have symptoms that last for more than 2 weeks.

  • Ask Doctor/Pharmacist

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

  • Dosage and Administration

    Directions

    - do not exceed the maximum recommended daily dose in a 24 hour period

    - shake well before use

    - do not use the maximum daily dose for more than 2 weeks

    Age (yr)

    Dose (mL)

    adults and children 12 years and over

    30 mL, not more than 60 mL in 24 hrs.

    children under 12 years

    ask a doctor

  • Warnings

    For Institutional Use Only

  • Keep Out of Reach of Children

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

  • Pregnancy or Breast Feeding

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

  • Inactive Ingredients

    Inactive ingredients citric acid, glycerin, microcrystalline cellulose, methyl cellulose, purified water, saccharin sodium, sodium citrate, spearmint oil, xanthan gum

  • Storage and Handling

    - store at 20-25°C (68-77°F)

    - protect from excessive moisture

    - see bottom of cup for lot number and expiration date

    Distributed By:

    MAJOR® PHARMACEUTICALS

    Livonia, MI 48152

    Refer to package label for Distributor's NDC Number

    Distributed By:

    Cardinal Health

    Dublin, OH 43017

    L57472900222

    Product Insert
  • Principal Display Panel

    Magnesium Hydroxide 2400 mg

    Aluminum Hyroxide 2400 mg

    Simethicone Max 240 mg

    5 cups

    bag label
  • INGREDIENTS AND APPEARANCE
    MAGNESIUM HYDROXIDE/ALUMINUM HYDROXICE/SIMETHICONE 
    magnesium hydroxide,aluminum hydroxice,simethicone suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-3557(NDC:0904-6839)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE2400 mg  in 30 mL
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE240 mg  in 30 mL
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (HYDROXIDE ION - UNII:9159UV381P, MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE2400 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    METHYLCELLULOSE (15 MPA.S) (UNII: NPU9M2E6L8)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorwhite (Suspension) Score    
    ShapeSize
    FlavorSPEARMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55154-3557-55 in 1 BAG12/27/2019
    130 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33112/27/2019
    Labeler - Cardinal Health 107, LLC (118546603)