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
  • 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 May 27, 2021

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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 FINALpart33105/27/2021
    Labeler - Retail Business Services, LLC. (967989935)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guardian Drug Company119210276MANUFACTURE(72476-516)
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