Label: ANTACID- aluminum hydroxide, magnesium hydroxide, simethicone liquid

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated August 5, 2024

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  • ACTIVE INGREDIENTS (in each 10 mL )

    Aluminum hydroxide (equiv. to dried gel, USP) 400 mg
    Magnesium hydroxide 400 mg
    Simethicone 40 mg

  • PURPOSE

    Antacid
    Antacid
    Antigas

  • USE(S)

    relieves:

    •
    acid indigestion
    •
    heartburn
    •
    sour stomach
    •
    upset stomach and gas associated with these symptoms 
  • WARNINGS

    Do not take more than 80 mL in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor.

  • 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 DOCTOR

    if symptoms last more than two weeks

  • KEEP OUT OF REACH OF CHILDREN

    .

  • DIRECTIONS

    •
    shake well before use
    •
    mL = milliliter
    •
    adults and children 12 years and older: take 10 mL to 20 mL four times a day, or as directed by a doctor
    •
    children under 12 years: consult a doctor
  • OTHER INFORMATION

    •
    each 10 mL contains: magnesium 170 mg, sodium 5 mg
    •
    store at controlled room temperature 20ºC-25ºC (68º-77ºF)
    •
    do not freeze
  • INACTIVE INGREDIENTS

    ethyl alcohol, flavor, glycerin, hydroxyethyl cellulose, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, simethicone emulsion, sorbitol

  • PRINCIPAL DISPLAY PANEL

    Rugby

    NDC 68788-8506-3

    Regular Strength
    Antacid Liquid
    Aluminum hydroxide, 400 mg
    Magnesium hydroxide, 400 mg
    Simethicone, 40 mg

        

    Antacid and Antigas
    Original Flavor

     

    Relief of:

    Heartburn

    Acid Indigestion

    Sour Stomach

    Pressure & Bloating

     
    12 FL OZ (355 mL)
    Alcohol content 0.2% v/v

    Regular Strength Antacid Liquid
  • INGREDIENTS AND APPEARANCE
    ANTACID 
    aluminum hydroxide, magnesium hydroxide, simethicone liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-8506(NDC:0536-1293)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE400 mg  in 10 mL
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE400 mg  in 10 mL
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE40 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68788-8506-3355 mL in 1 BOTTLE; Type 0: Not a Combination Product08/15/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drugpart33106/02/2021
    Labeler - Preferred Pharmaceuticals Inc. (791119022)
    Registrant - Preferred Pharmaceuticals Inc. (791119022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Preferred Pharmaceuticals Inc.791119022RELABEL(68788-8506)
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