Label: ANTACID ANTIGAS- 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 October 26, 2015

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

View All Sections
  • Active Ingredients

    Aluminum hydroxide (equivalent to Dried Gel, USP) 200 mg
    Magnesium hydroxide 200 mg
    Simethicone 20 mg

  • 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.

  • Directions

    • shake well before use
    • do not exceed 24 teaspoons (120 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

  • Other Information

    • do not freeze
    • store at room temperature tightly closed
    • each teaspoon contains:
    potassium 2 mg, magnesium 83 mg

  • Inactive Ingredients

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

  • Principal Display Panel

    This product is not manufactured or distributed by johnson and johnson Merck, distributor of Mylanta



    image of label
  • Purposes

    Antacid

    Antacid

    Antigas

  • INGREDIENTS AND APPEARANCE
    ANTACID ANTIGAS 
    aluminum hydroxide, magnesium hydroxide, dimethicone suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-004
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE200 mg  in 5 mL
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE200 mg  in 5 mL
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE20 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorLEMON (Maalox Type Lemon Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-004-12355 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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!