Label: REGULAR STRENGTH ANTACID- aluminum hydroxide, magnesium hydroxide, dimethicone liquid

  • NDC Code(s): 46122-433-40
  • Packager: AMERISOURCEBERGEN DRUG CORPORATION
  • 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 40mg

  • Purposes

    Antacid
    Antigas

  • Uses

    relieves

    • heartburn
    • sour stomach
    • acid indigestion
    • the symptoms referred to as gas
  • Warnings

    Do not take more than 120 mL (12 doses) in a 24 hour period or use
    the maximum dosage for more than 2 weeks.

    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.
    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 and older: take 2 to 4 teaspoonfuls between meals, at bedtime, or as directed by a doctor
    • do not take more than 24 teaspoonfuls in 24 hours or use the maximum dosage for more than 2 weeks
    • children under 12 years: ask a doctor
  • Other information

    • each 10 mL dose contains: magnesium 165 mg, sodium 6 mg
    • store at room temperature
    • 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

    1

  • INGREDIENTS AND APPEARANCE
    REGULAR STRENGTH ANTACID 
    aluminum hydroxide, magnesium hydroxide, dimethicone liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-433
    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)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorLEMON (lemon) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46122-433-40355 mL in 1 BOTTLE; Type 0: Not a Combination Product01/31/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00101/01/2000
    Labeler - AMERISOURCEBERGEN DRUG CORPORATION (007914906)
    Registrant - GCP Laboratories (965480861)
    Establishment
    NameAddressID/FEIBusiness Operations
    GCP Laboratories965480861manufacture(46122-433)
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