Label: GOOD SENSE ANTACID- aluminum hydroxide, magnesium hydroxide, simethicone suspension

  • 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 October 9, 2018

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  • 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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