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

  • NDC Code(s): 72476-516-05
  • Packager: Retail Business Services, LLC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 11, 2024

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  • ACTIVE INGREDIENT (in each 10 mL )

    Aluminum hydroxide (equiv. to dried gel, USP) 800 mg
    Magnesium hydroxide 800 mg
    Simethicone 80 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 60 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
    • adults and children 12 years and older: take 10 - 20 mL two times a day, or as directed by a doctor
    • children under 12 years: consult a doctor
    • mL = milliliter
  • OTHER INFORMATION

    • each 10 mL contains: magnesium 340 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

    CAREONE
    NDC 72476-516-05

    Compare to the active ingredients in Mylanta® Maximum Strength

    MAXIMUM STRENGTH

    ANTACID LIQUID

    Aluminum Hydroxide 800mg

    Magnesium Hydroxide 800mg

    Simethicone 80mg

    Original Flavor

    Relieves: 

    Acid Indigestion, Pressure & Bloating (Gas)

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

    79

  • INGREDIENTS AND APPEARANCE
    ANTACID 
    aluminum hydroxide, magnesium hydroxide, simethicone liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72476-516
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE800 mg  in 10 mL
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE800 mg  in 10 mL
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE80 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorMINT (Lemon Mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72476-516-05355 mL in 1 BOTTLE; Type 0: Not a Combination Product05/27/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00105/27/2021
    Labeler - Retail Business Services, LLC. (967989935)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guardian Drug Company119210276MANUFACTURE(72476-516)
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