Label: ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE AND SIMETHICONE SUSPENSION MAXIMUM STRENGTH- aluminum hydroxide, magnesium hydroxide, and simethicone suspension
ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE AND SIMETHICONE SUSPENSION- aluminum hydroxide, magnesium hydroxide, and simethicone suspension

  • NDC Code(s): 0904-7325-62, 0904-7325-73, 0904-7326-62, 0904-7326-73
  • Packager: MAJOR® PHARMACEUTICALS
  • 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 August 1, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • PURPOSE

    Drug Facts

  • ACTIVE INGREDIENT

    1,200-1,200-120 mg/30 mL

    Active ingredients (in each 30 mL)                                               Purpose 

    Aluminum hydroxide 1,200 mg (equivalent to dried gel, USP)..............Antacid
    Magnesium hydroxide 1,200 mg......................................................Antacid
    Simethicone 120 mg......................................................................Antigas

    2,400-2,400-240 mg/30 mL

    Active ingredient (in each 30 mL)                                               Purpose
    Aluminum hydroxide 2,400 mg (equivalent to dried gel, USP)..............Antacid
    Magnesium hydroxide 2,400 mg......................................................Antacid
    Simethicone 240 mg......................................................................Antigas

  • Usesrelieves • 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 aretaking another medication. This product may interact with certain medications.

    Stop use and ask a doctor ifsymptoms 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 use

    1,200-1,200-120 mg/30 mL

     agedose
    Adults and children 12 years and older30mL, not more than 120 mL in 24 hrs 
    Children under 6 years of ageDo not use unless directed by a doctor

    2,400-2,400-240 mg/30 mL

     agedose
    Adults and children 12 years and older30mL, not more than 60 mL in 24 hrs
    Children under 6 years of ageDo not use unless directed by a doctor

  • Other information

    1,200-1,200-120 mg/30 mL

    • each 30 mL containsmagnesium 510 mg and sodium 18 mg
    • protect from freezing
    • store at 20° to 25°C (68° to 77°F).
    • do not use if lid seal is open or damaged
    • retain this insert for full product information

    2,400-2,400-240 mg/30 mL

    • each 30 mL containsmagnesium 990 mg, sodium 30 mg
    • store at 20° to 25°C (68° to 77°F). 
    • protect from freezing
    • do not use if lid seal is open or damaged
    • retain this insert for full product information
  • INACTIVE INGREDIENT

    Inactive ingredientsbenzyl alcohol, butylparaben, carboxy-methycellulose sodium, flavor, hypromellose, microcrystalline cellulose, propylparaben, purified water, saccharin sodium, sorbitol solution

  • QUESTIONS

    Questions or comments?(855) 879-4368

    Distributed by:
    MAJOR® PHARMACEUTICALS
    Indianapolis, IN 46268

    (800) 616-2471

    Rev. 06/23

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    MAJOR®

    NDC 0904-7325-62

    Each 30 mL Contains:

    Magnesium hydroxide 1,200 mg

    Aluminum hydroxide 1,200 mg 

    Simethicone 120 mg

    SHAKE WELL

    Delivers 30 mL • See insert

    For Institutional Use Only 

    MAJOR® PHARMACEUTICALS

    Indianapolis, IN 46268

    aapdp

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    MAJOR®

    NDC 0904-7326-62

    Each 30 mL Contains:

    Magnesium hydroxide 2,400 mg

    Aluminum hydroxide 2,400 mg 

    Simethicone 240 mg

    SHAKE WELL

    Delivers 30 mL • See insert

    For Institutional Use Only 

    MAJOR® PHARMACEUTICALS

    Indianapolis, IN 46268

    aampdp

  • INGREDIENTS AND APPEARANCE
    ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE AND SIMETHICONE SUSPENSION MAXIMUM STRENGTH 
    aluminum hydroxide, magnesium hydroxide, and simethicone suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-7326
    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) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE2400 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    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)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-7326-7310 in 1 CASE08/01/2023
    110 in 1 TRAY
    1NDC:0904-7326-6230 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 finalpart33108/01/2023
    ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE AND SIMETHICONE SUSPENSION 
    aluminum hydroxide, magnesium hydroxide, and simethicone suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-7325
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE1200 mg  in 30 mL
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE1200 mg  in 30 mL
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE120 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-7325-7310 in 1 CASE08/01/2023
    110 in 1 TRAY
    1NDC:0904-7325-6230 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 finalpart33107/05/2023
    Labeler - MAJOR® PHARMACEUTICALS (191427277)