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 April 30, 2018

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  • Active ingredients (in each 5 mL = 1 teaspoonful)

    Aluminum hydroxide (Equi. To Dried Gel, USP) 200 mg

    Magnesium hydroxide 200 mg

    Simethicone 20 mg

  • Purpose

    Antacid

    Antigas

  • Uses

    relieves

    •
    heartburn
    •
    acid indigestion
    •
    sour stomach
    •
    associated symptoms of gas and upset stomach
    •
    overindulgence of food and drink
  • 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 for more than 2 weeks

    Keep out of reach of children.

    In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

  • Directions

    •
    shake well before each use
    •
    Adults/children 12 years and older, take 2 - 4 teaspoonsful between meals, at bedtime or as directed by a physician
    •
    do not take more than 12 teaspoonsful in 24
    •
    do not use the maximum dosage for more than 2 weeks
    •
    children under 12 years: consult a physician
  • Other information

    •
    TAMPER EVIDENT: DO NOT USE IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING
    •
    Store at room temperature 15º - 30ºC (59º - 86ºF)
    •
    keep tightly closed
    •
    protect from freezing
    •
    each teaspoon (5 mL) contains: magnesium 83 mg
    •
    each teaspoon (5 mL) contains: sodium 1 mg
    •
    does not meet USP requirements for preservative effectiveness
  • Inactive ingredients

    flavors, hypromellose, parabens, saccharin, sodium hypochlorite, sorbitol, water and xanthan gum

  • Principal Display Panel

    Antacid Front Label ImageAntacid Back Label Image

  • INGREDIENTS AND APPEARANCE
    ANTACID 
    aluminum hydroxide, magnesium hydroxide, simethicone liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53807-126
    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, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE200 mg  in 5 mL
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE20 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    SACCHARIN (UNII: FST467XS7D)  
    SODIUM HYPOCHLORITE (UNII: DY38VHM5OD)  
    SORBITOL (UNII: 506T60A25R)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    LEMON OIL (UNII: I9GRO824LL)  
    Product Characteristics
    ColorWHITE (opaque) Score    
    ShapeSize
    FlavorLEMONImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53807-126-12355 mL in 1 BOTTLE; Type 0: Not a Combination Product03/16/1999
    2NDC:53807-126-283785 mL in 1 BOTTLE; Type 0: Not a Combination Product03/16/1999
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33203/16/1999
    Labeler - Rij Pharmaceutical Corporation (144679156)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rij Pharmaceutical Corporation144679156manufacture(53807-126)
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