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

  • 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 January 4, 2012

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  • Active ingredient (in each 5 mL teaspoon)

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

    Magnesium hydroxide 200 mg

    Simethicone 20 mg

  • Purpose

    Antacid

    Antigas

  • Uses

    for the relief of

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

  • 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
  • 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
  • Inactive ingredients

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

  • Questions or comments?

    1-800-719-9260

  • 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

  • INGREDIENTS AND APPEARANCE
    MAALOX ANTACID 
    aluminum hydroxide, magnesium hydroxide, simethicone liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-2093(NDC:0113-0851)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE200 mg  in 5 mL
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM HYDROXIDE - UNII:NBZ3QY004S) MAGNESIUM HYDROXIDE200 mg  in 5 mL
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE20 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorWHITE (opaque) Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54868-2093-0355 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33212/12/2006
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Physicians Total Care, Inc.194123980relabel
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