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

  • NDC Code(s): 0904-6838-73, 0904-6839-73
  • Packager: Major Pharmaceuticals
  • 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 November 17, 2019

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

  • Magnesium hydroxide, Aluminum hydroxide, Simethicone 1200/1200/120 mg per 30 mL Major Pharmaceutical OTC Monograph

    701031 1200/1200/120 Mg/30 mLNDC 0904-6838-73

    Each 30 mL Contains:

    Magnesium Hydroxide1200 mg

    Aluminum Hydroxide 1200 mg

    Simethicone 120 mg

    Delivers 30 mL

    Shake Well

    See Insert

    For Instituional Use Only

    MAJOR PHARMACEUTICALS

    Livonia, MI 64152

    Sugar Free - Dye Free - Alcohol Free

    MgOH, AlOH, Simethicone 1200/1200/120 mg/30 mL

    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 120 mL in 24 hours

    children under 12 years

    ask a doctor

    MgOH, AlOH, Simethicone 1200/1200/120 mg/30 mL

    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)

    MgOH, AlOH, Simethicone 1200/1200/120 mg/30 mL

    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 presecription drug. Antacids may interact with certain prescription drugs.

    ___________________________________________________________________

    Stop use and ask a doctor if

    - you have symptoms that last more than 2 weeks

    ___________________________________________________________________

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

    MgOH, AlOH, Simethicone 1200/1200/120 mg/30 mL

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

    MgOH, AlOH, Simethicone 1200/1200/120 mg/30 mL

    Uses

    - acid indigestion

    - heartburn

    - sour stomach

    - upset stomach due to these symptoms

    - pressure and bloating commonly referred to as gas

    MgOH, AlOH, Simethicone 1200/1200/120 mg/30 mL

    Active ingredient (in each 30 mL cup)

    Magnesium hydroxide USP 1200 mg

    Magnesium hydroxide USP 1200 mg

    Simethicone 120 mg

    MgOH, AlOH, Simethicone 1200/1200/120 mg/30 mL

    Antacid

    Antacid

    Antigas

    MgOH, AlOH, Simethicone 1200/1200/120 mg/30 mL

    Other information

    - each 30 mL contains: calcium 40 mg, sodium 25 mg, and magnesium 500 mg

    - store at 20-25°C (68-77°F)

    - protect from excessive moisture

    - do not use if lid seal is open or damaged

    - sugar free, dye free, alcohol free

    - see bottom of cup for lot number and expiration date

    MgOH, AlOH, Simethicone 1200/1200/120 mg/30 mL

    701031 IFU

  • Magnesium hydroxide, Aluminum hydroxide, Simethicone 2400/2400/240 mg/30 mL Major Pharmaceutical OTC Monograph

    701032 LidNDC 0904-6839-73

    Each 30 mL Contains:

    Magnesium Hydroxide 2400 mg

    Aluminum Hydroxide 2400 mg

    Simethicone 240 mg

    Max

    Delivers 30 mL

    Shake Well

    See Insert

    For Instituional Use Only

    MAJOR PHARMACEUTICALS

    Livonia, MI 64152

    Sugar Free - Dye Free - Alcohol Free

    Magnesium hydroxide, Aluminum hydroxide, Simethicone 2400/2400/240 mg/30 mL

    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

    Magnesium hydroxide, Aluminum hydroxide, Simethicone 2400/2400/240 mg/30 mL

    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)

    Magnesium hydroxide, Aluminum hydroxide, Simethicone 2400/2400/240 mg/30 mL

    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

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

    ___________________________________________________________________

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

    Magnesium hydroxide, Aluminum hydroxide, Simethicone 2400/2400/240 mg/30 mL

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

    Magnesium hydroxide, Aluminum hydroxide, Simethicone 2400/2400/240 mg/30 mL

    Uses

    - acid indigestion

    - heartburn

    - sour stomach

    - upset stomach due to these symptoms

    - pressure and bloating commonly referred to as gas

    Magnesium hydroxide, Aluminum hydroxide, Simethicone 2400/2400/240 mg/30 mL

    Magnesium hydroxide, Aluminum hydroxide, Simethicone 2400/2400/240 mg/30 mL

    Antacid

    Antacid

    Antigas

    Magnesium hydroxide, Aluminum hydroxide, Simethicone 2400/2400/240 mg/30 mL

    Other information

    - each 30 mL contains: calcium 40 mg, sodium 25 mg, and magnesium 1000 mg

    - store at 20-25°C (68-77°F) -

    - protect from excessive moisture

    - do not use if lid seal is open or damaged -

    - sugar free, dye free, alcohol free

    - see bottom of cup for lot number and expiration date

    Magnesium hydroxide, Aluminum hydroxide, Simethicone 2400/2400/240 mg/30 mL

    701032 IFU

  • INGREDIENTS AND APPEARANCE
    MAGNESIUM HYDROXIDE/ALUMINUM HYDROXICE/SIMETHICONE 
    magnesium hydroxide,aluminum hydroxice,simethicone suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6839
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE240 mg  in 30 mL
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE2400 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 CPS) (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:0904-6839-7310 in 1 CASE12/27/2019
    110 in 1 TRAY
    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
    MAGNESIUM HYDROXIDE/ALUMINUM HYDROXICE/SIMETHICONE 
    magnesium hydroxide/aluminum hydroxice/simethicone suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6838
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE120 mg  in 30 mL
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE1200 mg  in 30 mL
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (HYDROXIDE ION - UNII:9159UV381P, MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE1200 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    METHYLCELLULOSE (15 CPS) (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:0904-6838-7310 in 1 CASE12/27/2019
    110 in 1 TRAY
    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 - Major Pharmaceuticals (191427277)
    Registrant - Plastikon Healthcare, LLC (041717941)
    Establishment
    NameAddressID/FEIBusiness Operations
    Plastikon Healthcare, LLC041717941manufacture(0904-6838, 0904-6839)