Label: EQUALINE ANTACID- aluminum hydroxide, magnesium hydroxide and dimethicone liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/15

If you are a consumer or patient please visit this version.

  • Active ingredient (in each 5 mL = 1 teaspoonful)

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

    Magnesium hydroxide 400 mg

    Simethicone 40 mg

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  • Purpose

    Antacid

    Antigas

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  • Uses

    for the relief of

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

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  • Directions

    shake well before using
    adults and children 12 years and older: take 2 to 4 teaspoonsful two times a day or as directed by a physician
    do not take more than 8 teaspoonsful in 24 hours or use the maximum dosage for more than 2 weeks
    children under 12 years: consult a physician
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  • Other information

    each teaspoonful contains: magnesium 175 mg and sodium 2 mg
    does not meet USP requirements for preservative effectiveness
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  • Inactive ingredients

    butylparaben, flavor, glycerin, hydroxyethyl cellulose, propylene glycol, propylparaben, purified water, saccharin sodium, simethicone emulsion, sorbitol, sorbitol solution

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  • Questions or comments?

    1-877-932-7948

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  • Principal Display Panel

    compare to Maalox® Advanced active ingredients

    maximum strength

    antacid

    advanced

    (antacid & antigas)

    fast relief of:

    heartburn & acid indigestion

    pressure & bloating

    cherry flavored

    liquid

    ALCOHOL 0.1%

    12 FL OZ (355mL)

    Equaline Antacid Advanced Image 1
    Equaline Antacid Advanced Image 2
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  • INGREDIENTS AND APPEARANCE
    EQUALINE ANTACID 
    aluminum hydroxide, magnesium hydroxide, simethicone liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:41163-588
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE 400 mg  in 5 mL
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE 400 mg  in 5 mL
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 40 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    Color WHITE (opaque) Score     
    Shape Size
    Flavor CHERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41163-588-40 355 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part332 09/11/2012
    Labeler - Supervalu Inc (006961411)
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