Label: ALUMINA, MAGNESIA, AND SIMETHICONE ORAL SUSPENSION REGULAR STRENGTH suspension

  • NDC Code(s): 66689-060-01, 66689-060-99
  • Packager: VistaPharm, Inc.
  • 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 September 14, 2020

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  • Drug Facts

    Active ingredients                                                             

    (in each 30 mL dose)

    Aluminum hydroxide 1200 mg

    (equivalent to dried gel, USP)

    Magnesium hydroxide 1200 mg

    Simethicone 120 mg

  • Purposes

    Aluminum hydroxide............................................Antacid 

    (equivalent to dried gel, USP)

    Magnesium hydroxide..........................................Antacid

    Simethicone.........................................................Antigas

  • Uses

    relieves:

    • 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 are taking a prescription drug. Antacid may interact with certain prescription drugs.

    When using this product

    • do not take more than 120 mL (4 doses) in a 24-hour period 
    • do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor

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

    Keep out of reach of children.

  • Directions

    • shake well before use
    • adults and children 12 years and older: 30 mL (1 dose) up to 4 times a day or as directed by a doctor 
    • children under 12 years of age: ask a doctor
  • Other information

    • each 30 mL contains: magnesium 510 mg, sodium 18 mg
    • store at 20-25°C (68-77°F)
    • protect from freezing
    • keep tightly closed
    • tamper-evident: do not use if foil on cup is missing or torn
  • Inactive ingredients

    benzyl alcohol, butylparaben, flavor (contains alcohol), hydroxyethyl cellulose, propylparaben, purified water, saccharin sodium, sorbitol solution

  • Questions or comments?

    Call 1-888-655-1505

  • How Supplied

    Alumina, Magnesia, and Simethicone Oral Suspension is a white suspension supplied as follows:

    NDC 66689-060-01: 30 mL unit-dose cup
    NDC 66689-060-99: Case contains 100 unit-dose cups of 30 mL (NDC 66689-060-01), packaged in 10 trays of 10 unit-dose cups each.

    Distributed by:
    VistaPharm Inc.
    Largo, FL 33771, USA

    VP2184
    05/20

  • Principal Display Panel

    REGULAR STRENGTH

    Alumina, Magnesia, and

    Simethicone Oral Suspension

    each 30 mL contains:

    Aluminum Hydroxide Gel…………1200 mg

    Magnesium hydroxide…………….1200 mg

    Simethicone………………………..120 mg

    Alcohol 0.15%

    Delivers 30 mL

    Store at 20°-25°C (68°-77°F). Shake Well

    Distributed by: VistaPharm

    Largo, FL 33771, USA  

    VP2187

    Rev.06/20

    NDC 66689-060-01

    Lidding Label
  • INGREDIENTS AND APPEARANCE
    ALUMINA, MAGNESIA, AND SIMETHICONE ORAL SUSPENSION REGULAR STRENGTH 
    alumina, magnesia, and simethicone oral suspension regular strength suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66689-060
    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) 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)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    May containALCOHOL (UNII: 3K9958V90M)  
    Product Characteristics
    ColorWHITE (white suspension) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66689-060-99100 in 1 CASE09/15/2020
    1NDC:66689-060-0130 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 FINALpart33109/15/2020
    Labeler - VistaPharm, Inc. (116743084)
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