Label: ANTACID- aluminum hydroxide, magnesium hydroxide, simethicone liquid

  • 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 June 2, 2021

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  • ACTIVE INGREDIENTS (in each 10 mL )

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

  • PURPOSE

    Antacid
    Antacid
    Antigas

  • USE(S)

    relieves:


    • acid indigestion
    • heartburn
    • sour stomach
    • upset stomach and gas associated with these symptoms 
  • WARNINGS

    Do not take more than 80 mL in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor.

  • 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 DOCTOR

    if symptoms last more than two weeks

  • KEEP OUT OF REACH OF CHILDREN

    .

  • DIRECTIONS

    • shake well before use
    • mL = milliliter
    • adults and children 12 years and older: take 10 mL to 20 mL four times a day, or as directed by a doctor
    • children under 12 years: consult a doctor
  • OTHER INFORMATION

    • each 10 mL contains: magnesium 170 mg, sodium 5 mg
    • store at controlled room temperature 20ºC-25ºC (68º-77ºF)
    • do not freeze
  • INACTIVE INGREDIENTS

    ethyl alcohol, flavor, glycerin, hydroxyethyl cellulose, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, simethicone emulsion, sorbitol

  • PRINCIPAL DISPLAY PANEL

    Rugby

    NDC 0536-1293-83

    Regular Strength
    Antacid Liquid
    Aluminum hydroxide, 400 mg
    Magnesium hydroxide, 400 mg
    Simethicone, 40 mg

        

    Antacid and Antigas
    Original Flavor

     

    Relief of:

    Heartburn

    Acid Indigestion

    Sour Stomach

    Pressure & Bloating


     
    12 FL OZ (355 mL)
    Alcohol content 0.2% v/v


    80




  • INGREDIENTS AND APPEARANCE
    ANTACID 
    aluminum hydroxide, magnesium hydroxide, simethicone liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1293
    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) MAGNESIUM HYDROXIDE400 mg  in 10 mL
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE40 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1293-83355 mL in 1 BOTTLE; Type 0: Not a Combination Product06/02/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33106/02/2021
    Labeler - Rugby Laboratories (079246066)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guardian Drug Company119210276MANUFACTURE(0536-1293)
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