Label: ANTACID ANTIGAS MAXIMUM STRENGTH- aluminum hydroxide, magnesium hydroxide, dimethicone 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 February 4, 2016

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  • Active ingredients

    Aluminum hydroxide(equivalent to Dried Gel, USP) 400 mg
    Magnesium hydroxide 400 mg
    Simethicone 40 mg

  • Purpose

    Antacid
    Antigas

  • Uses

    relieves: • heartburn • sour stomach • acid indigestion
    • upset stomach due to these symptoms • symptoms of 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

  • Stop use and ask a doctor

    if symptoms last for more
    than 2 weeks

  • If pregnant or breast-feeding

    ask a health professional before use.

  • Keep this and all drugs out of the reach of children.

    In case of accidental overdose, seek professional assistance
    or contact a Poison Control Center immediately.

  • Other information

    store at room temperature tightly closed

    do not freeze

    each teaspoon contains:

    potassium 2 mg, magnesium 167 mg

  • Inactive ingredients

    benzyl alcohol,
    flavors, glycerin, hydroxyethyl cellulose,
    potassium citrate, propylene glycol,
    purified water, sorbitol

  • Directions

    • shake well before use
    • do not exceed 12 teaspoons (60 mL) in a 24 hour period or use the maximum dosage for more than 2 weeks
    • adults and children 12 years of age and older: take 2 to 4 teaspoons (10-20 mL) between meals and at bedtime or as directed by a doctor
    • children under 12 years of age: ask a doctor
  • Package Label

     Aluminum hydroxide 400 mg, Magnesium hydroxide 400 mg, Dimethicone 40 mg

    Antacid Antigas Maximum Strength

  • INGREDIENTS AND APPEARANCE
    ANTACID ANTIGAS MAXIMUM STRENGTH 
    aluminum hydroxide, magnesium hydroxide, dimethicone suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-050
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE400 mg  in 5 mL
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE400 mg  in 5 mL
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE40 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorLEMON (Lemon) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-050-12355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33106/03/2009
    Labeler - Chain Drug Consortium, LLC (101668460)
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