GOOD SENSE ANTACID (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) SUSPENSION [A-S MEDICATION SOLUTIONS]

GOOD SENSE ANTACID (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) SUSPENSION [A-S MEDICATION SOLUTIONS]
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NDC 50090-3401-0
Set ID 60518af3-965f-4d00-853a-9551fc3c398c
Category HUMAN OTC DRUG LABEL
Packager A-S Medication Solutions
Generic Name
Product Class
Product Number
Application Number PART332
  • Active ingredients (in each 10 mL)

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

    Magnesium hydroxide 400 mg

    Simethicone 40 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

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

    When using this product

    do not take more than 80 mL in a 24-hour period, or use the maximum dosage for more than 2 weeks, except under the advice and supervision of a physician

    Keep out of reach of children.

  • Directions

    shake well before using
    only use the dose cup provided
    adults and children 12 years and older: take 10 mL to 20 mL four times a day or as directed by a physician
    do not take more than 80 mL in 24 hours or use the maximum dosage for more than 2 weeks
    children under 12 years: consult a physician
  • Other information

    each 10 mL contains: magnesium 175 mg
    does not meet USP requirements for preservative effectiveness
    store at 20-25ºC (68-77ºF)
    protect from freezing
  • Inactive ingredients

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

  • Questions or comments?

    1-800-719-9260

  • Aluminum hydroxide, Magnesium hydroxide, Simethicone

    Label Image
  • INGREDIENTS AND APPEARANCE
    GOOD SENSE ANTACID 
    aluminum hydroxide, magnesium hydroxide, simethicone suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-3401(NDC:0113-0851)
    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)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    Product Characteristics
    ColorWHITE (opaque) Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50090-3401-0355 mL in 1 BOTTLE; Type 0: Not a Combination Product03/14/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33202/04/2003
    Labeler - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-3401)

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