Label: ANTACID ANTIGAS - aluminum hydroxide, magnesium hydroxide and dimethicone suspension

  • NDC Code(s): 49580-0106-6
  • Packager: Aaron Industries, Inc.
  • 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 11/09

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

  • Active Ingredients

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

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  • Uses

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

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  • Ask a doctor before use if you have

    • kidney disease • a magnesium restricted diet

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  • Ask a doctor or pharmacist before use if you are

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

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  • Stop use and ask a doctor if

    symptoms last for more than 2 weeks

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  • If pregnant or breast-feeding

    ask a health professional before use.

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  • 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.

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  • 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

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  • Other Information

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

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  • Inactive Ingredients

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

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  • Principal Display Panel

    * This Product is not manufactured or distributed by Johnson and Johnson Merck, distributor of Mylanta®

    Manufactured By

    Aaron Industries, Inc.

    P.O. Box 801 Lynwood , CA 90262

    image of back label



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  • INGREDIENTS AND APPEARANCE
    ANTACID ANTIGAS 
    mylanta suspension
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49580-0106
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Aluminum Hydroxide (Aluminum Hydroxide) Aluminum Hydroxide 200 mg  in 5 mL
    Magnesium Hydroxide (Magnesium Hydroxide) Magnesium Hydroxide 200 mg  in 5 mL
    Dimethicone (Dimethicone) Dimethicone 20 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    BENZYL ALCOHOL  
    GLYCERIN  
    HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)  
    POTASSIUM CITRATE  
    PROPYLENE GLYCOL  
    WATER  
    SORBITOL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49580-0106-6 177 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part331 04/08/2009
    Labeler - Aaron Industries, Inc. (101896231)
    Registrant - Aaron Industries, Inc. (101896231)
    Establishment
    Name Address ID/FEI Business Operations
    Aaron Industries, Inc. 101896231 manufacture, analysis
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