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

  • 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 December 12, 2018

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

  • Active ingredients (in each 10 mL)

    Aluminum hydroxide (equiv. to dried gel, USP) 800 mg

    Magnesium hydroxide 800 mg

    Simethicone 80 mg

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  • Purposes

    Antacid

    Antigas

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  • Uses

    relieves

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

    presently taking a prescription drug. Antacids may interact with certain prescription drugs.

    When using this product

    do not exceed 60 mL in a 24-hour period, or use the maximum dosage for more than 2 weeks

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

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  • Directions

    shake well before use
    measure with dosing cup provided
    adults and children 12 years and over: 10 mL – 20 mL between meals, at bedtime or as directed by a doctor
    do not take more than 60 mL in any 24 hour period
    do not use the maximum dosage for more than 2 weeks
    children under 12 years: ask a doctor
    mL = milliliter
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  • Other information

    each 10 mL contains: magnesium 350 mg, potassium 20 mg and sodium 3 mg
    does not meet USP requirements for preservative effectiveness
    store at 20-25 °C (68-77 °F), do not freeze
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  • Inactive ingredients

    butylparaben, flavor, hypromellose, microcrystalline cellulose and carboxymethylcellulose sodium, potassium citrate, propylparaben, purified water, simethicone emulsion, sorbitol, sorbitol solution

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  • Questions or comments?

    1-800-719-9260

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  • Principal Display Panel

    Compare to the active ingredients in Mylanta® Maximum Strength

    MAXIMUM STRENGTH

    Antacid Liquid

    ALUMINUM HYDROXIDE / MAGNESIUM HYDROXIDE / SIMETHICONE

    Antacid / Anti-Gas

    Fast-Acting

    Soothing relief of:

    Heartburn

    Acid indigestion

    Sour stomach

    Original Flavor

    12 FL OZ (355 mL)

    Antacid Liquid image
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  • INGREDIENTS AND APPEARANCE
    ANTACID 
    aluminum hydroxide, magnesium hydroxide, simethicone suspension
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-340
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE 800 mg  in 10 mL
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE 800 mg  in 10 mL
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 80 mg  in 10 mL
    Inactive Ingredients
    Ingredient Name Strength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Color WHITE (opaque) Score     
    Shape Size
    Flavor LEMON Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:69842-340-40 355 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/12/2016
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part331 06/12/2016
    Labeler - CVS Pharmacy (062312574)
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