Label: MAALOX ANTACID - aluminum hydroxide, magnesium hydroxide and dimethicone liquid 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/12

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

  • Active ingredient (in each 5 mL teaspoon)

    Aluminum hydroxide (equiv. to dried gel, USP) 200 mg

    Magnesium hydroxide 200 mg

    Simethicone 20 mg

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  • Purpose

    Antacid

    Antigas

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  • Uses

    for the relief of

    • acid indigestion
    • heartburn
    • sour stomach
    • upset stomach associated with 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

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

    When using this product

    do not exceed 16 teaspoonsful (80 mL) in a 24-hour period or use the maximum dosage for more than 2 weeks unless directed by a doctor

    Keep out of reach of children.

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  • Directions

    • shake well before using
    • adults and children 12 years and older: take 2-4 tsp (10-20 mL) up to 4 times a day or as directed by a doctor
    • children under 12: ask a doctor
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  • Other information

    • each teaspoon contains: calcium 25 mg and magnesium 85 mg
    • store at 20°-25°C (68°-77°F)
    • does not meet USP requirements for preservative effectiveness
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  • Inactive ingredients

    butylparaben, carboxymethylcellulose sodium, flavor, hypromellose, microcrystalline cellulose, propylparaben, purified water, saccharin sodium, simethicone emulsion, sorbitol

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  • Questions or comments?

    1-800-719-9260

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  • Principal Display Panel

    Regular Strength

    Liquid Antacid

    Antacid & Anti-Gas

    Fast Relief of:

    Heartburn

    Acid Indigestion

    Sour Stomach & Upset Stomach

    Mint Flavor

    Maalox Antacid     12 fl oz (355 mL)

    NDC 54868-2093-0

    image of package label

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  • INGREDIENTS AND APPEARANCE
    MAALOX ANTACID 
    aluminum hydroxide, magnesium hydroxide, simethicone liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:54868-2093(NDC:0113-0851)
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ALUMINUM HYDROXIDE (ALUMINUM HYDROXIDE) ALUMINUM HYDROXIDE 200 mg  in 5 mL
    MAGNESIUM HYDROXIDE (MAGNESIUM HYDROXIDE) MAGNESIUM HYDROXIDE 200 mg  in 5 mL
    DIMETHICONE (DIMETHICONE) DIMETHICONE 20 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    SILICON DIOXIDE  
    BUTYLPARABEN  
    CARBOXYMETHYLCELLULOSE SODIUM  
    HYPROMELLOSES  
    CELLULOSE, MICROCRYSTALLINE  
    PROPYLPARABEN  
    WATER  
    SACCHARIN SODIUM  
    SORBITOL  
    Product Characteristics
    Color WHITE (opaque) Score     
    Shape Size
    Flavor MINT Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54868-2093-0 355 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part332 12/12/2006
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    Name Address ID/FEI Business Operations
    Physicians Total Care, Inc. 194123980 relabel
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