EXCHANGE SELECT ANTACID REGULAR STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) SUSPENSION [ARMY & AIR FORCE EXCHANGE SERVICE]

EXCHANGE SELECT ANTACID REGULAR STRENGTH (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) SUSPENSION [ARMY & AIR FORCE EXCHANGE SERVICE]
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NDC 55301-357-40
Set ID 6b272dd2-34f2-4d32-92b5-3967be18f579
Category HUMAN OTC DRUG LABEL
Packager Army & Air Force Exchange Service
Generic Name
Product Class
Product Number
Application Number PART331
  • Active ingredient (in each 10 mL)

    Aluminum hydroxide (equiv. to dried gel, USP) 400 mg

    Magnesium hydroxide 400 mg

    Simethicone 40 mg

  • Purposes

    Antacid

    Antigas

  • Uses

    relieves

    heartburn
    acid indigestion
    sour stomach
    upset stomach due to 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

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

    When using this product

    do not exceed 120 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.

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

  • 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 120 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
  • Other information

    each 10 mL contains: magnesium 175 mg
    does not meet USP requirements for preservative effectiveness
    store at 20-25°C (68-77°F), do not freeze
  • Inactive ingredients

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

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    REGULAR STRENGTH

    antacid

    ANTACID ● ANTI-GAS

    Works on Contact!

    Tough on Heartburn

    CLASSIC ORIGINAL FLAVOR

    ALCOHOL 0.2%

    12 FL OZ (355 mL)

    quality value

    antacid image
  • INGREDIENTS AND APPEARANCE
    EXCHANGE SELECT ANTACID  REGULAR STRENGTH
    aluminum hydroxide, magnesium hydroxide, simethicone suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55301-357
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE400 mg  in 10 mL
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE400 mg  in 10 mL
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE40 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorWHITE (opaque) Score    
    ShapeSize
    FlavorMINT, LEMONImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55301-357-40355 mL in 1 BOTTLE; Type 0: Not a Combination Product01/08/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33101/08/2013
    Labeler - Army & Air Force Exchange Service (001695568)

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