Label: ANTACID AND GASRELIEF- aluminum hydroxide, magnesium hydroxide, dimethicone suspension

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 7, 2023

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  • Active ingredients (in each 10 mL dose)

    Aluminum hydroxide 400 mg (equivalent to dried gel, USP)
    Magnesium hydroxide 400 mg
    Simethicone 40 mg

  • Purposes

    Antacid

    Antigas

  • Uses

    relieves

    • heartburn
    • sour stomach
    • acid indigestion
    • the symptoms 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 taking a

    prescription drug. Antacids may interact with certain prescription drugs.

    Stop use and ask a doctor if symptoms last more than 2 weeks

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

  • Directions

    • shake well before use
    • adults and children 12 years of age and older: take 10 mL to 20 mL (1 to 2 doses) between meals as needed, at bedtime, or as directed by a doctor
    • do not exceed 120 mL (12 doses) in a 24 hour period or use the maximum dosage for more than 2 weeks
    • children under 12 years of age: ask a doctor
  • Other information

    • each 10 mL dose contains: magnesium 165 mg, sodium 6 mg
    • store at room temperature tightly closed protect from freezing
    • keep tightly closed
  • Inactive ingredients

    benzyl alcohol, butylparaben, flavor (contains alcohol), hydroxyethylcellulose, propylparaben, purified water, saccharin sodium, sorbitol solution

  • Questions or comments?

    1-800-540-3765​

  • package label

    2

  • INGREDIENTS AND APPEARANCE
    ANTACID AND GASRELIEF 
    aluminum hydroxide, magnesium hydroxide, dimethicone suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50804-629
    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
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50804-629-12355 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00107/01/2020
    Labeler - GOODSENSE (076059836)
    Registrant - GCP Laboratories (965480861)
    Establishment
    NameAddressID/FEIBusiness Operations
    GCP Laboratories965480861manufacture(50804-629)
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