MAALOX ANTACID (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [PHYSICIANS TOTAL CARE, INC.]

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MAALOX ANTACID (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [PHYSICIANS TOTAL CARE, INC.]
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NDC 54868-2093-0
Set ID e2a14762-3860-44c3-a3ea-5dbc45f4b1d5
Category HUMAN OTC DRUG LABEL
Packager Physicians Total Care, Inc.
Generic Name
Product Class
Product Number
Application Number PART332
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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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