Label: ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONE suspension

  • NDC Code(s): 0904-7557-62, 0904-7557-73
  • Packager: Major Pharmaceuticals
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 7, 2025

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

  • Drug Facts

    Active ingredients                                                                                 Purpose
    (in each 5 mL = 1 teaspoonful)

    Aluminum hydroxide (equiv. to dried gel, USP) 200 mg .......................... Antacid
    Magnesium hydroxide 200 mg .............................................................. Antacid
    Simethicone 20 mg ............................................................................... Antigas

  • PURPOSE

  • Uses for the relief of:

    • acid indigestion
    • heartburn
    • sour stomach
    • upset stomach due to these symptoms
    • pressure and bloating commonly referred to as gas
  • Warnings

    Do not take more than 16 teaspoonfuls in a 24-hour period or use the maximum dosage for more than 2 weeks except under the advice and supervision of a physician.

    Ask a doctor before use if you have

    • kidney disease
    • a magnesium-restricted diet


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


    Stop use and ask a doctor if symptoms last more than 2 weeks.

    Keep out of reach of children.

  • Directions

    • shake well before using
    • do not take more than 16 teaspoonfuls in 24 hours or use the maximum dosage for more than 2 weeks
    adults and children 12 years and oldertake 2 to 4 teaspoonfuls four times a day or as directed by a physician
    children under 12 yearsconsult a physician
  • Other information

    • each 5 mL contains: magnesium 83 mg, sodium 1.34 mg
    • store at controlled room temperature 20° - 25°C (68° - 77°F) {See USP Controlled Room Temperature].
    • protect from freezing
    • White colored, peppermint flavored liquid supplied in the following oral dosage form:

    NDC 0904-7557-62:  30 mL unit dose cup, in a tray of ten cups.

  • Inactive ingredients butylparaben, hydroxypropyl methylcellulose, flavoring, propylene glycol, propylparaben, purified water, saccharin sodium, and sorbitol solution.

  • Questions or comments?  Call 1-800-845-8210

  • SPL UNCLASSIFIED SECTION

    R02/25

    Distributed by:
    MAJOR® PHARMACEUTICALS
    Indianapolis, IN 46268

  • PRINCIPAL DISPLAY PANEL - 30 mL Unit-Dose Cup Lidding Label

    MAJOR®
    NDC 0904-7557-62

    Each 30 mL Contains:

    Magnesium Hydroxide     1200 mg
    Aluminum Hydroxide        1200 mg
    Simethicone                       120 mg

    SHAKE WELL

    Delivers 30 mL • See insert

    For Institutional Use Only

    MAJOR® PHARMACEUTICALS
    Indianapolis, IN 46268

     

      30 mL lidding label

     

  • INGREDIENTS AND APPEARANCE
    ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONE 
    aluminum hydroxide, magnesium hydroxide, and simethicone suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-7557
    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
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL (UNII: 506T60A25R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    WATER (UNII: 059QF0KO0R)  
    HYDROXYPROPYL METHYLCELLULOSE (UNII: 3NXW29V3WO)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorPEPPERMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-7557-7310 in 1 CASE07/07/2025
    110 in 1 TRAY
    1NDC:0904-7557-6230 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 DrugM00107/07/2025
    Labeler - Major Pharmaceuticals (191427277)