Label: ALUMOX- aluminum hydroxide, magnesium hydroxide, simethicone tablet, chewable

  • 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 January 17, 2020

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  • Active ingredients (in each tablet)

    Aluminum hydroxide (equiv. to dried gel, USP) 200 mg

    Magnesium hydroxide 200 mg

    Simethicone 25 mg

  • Purpose

    Antacid

    Antacid

    Antigas

  • KEEP OUT OF REACH OF CHILDREN

  • Uses

    relieves:

    acid indigestion

    heartburn

    sour stomach

    upset stomach & gas associated with these symptoms

  • 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

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

    Do not take

    more than 16 tablets 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.

    keep out of reach of children. In case of overdose get medical help or contact a poison control center immediately.

  • Directions

    • chew 1 to 4 tablets 4 times a day or as directed by a doctor.
  • Other information

    • each tablet contains: magnesium 85 mg
    • do not use if seal under cap is torn or missing
    • store at room temperature
    • keep tightly closed and dry
  • Inactive ingredients

    citric acid anhydrous, corn starch, D&C red 30 lake, D&C yellow 10 lake, dextrose, flavor, glycerin, magnesium stearate, maltodextrin, mannitol, pregelatinized starch, saccharin sodium, sorbitol, sugar

  • PDP

    Alumox

    Antacid+Antigas

    Lemon Flavor

    Aluminum Hydroxide / Antacid

    Magnesium Hydroxide / Antacid

    Simethicone / Antigas

    FOR FAST RELIEF OF:

    Acid indigestion

    Sour stomach

    Heartburn

    Gas

    100 Chewable Tablets

    SN

  • INGREDIENTS AND APPEARANCE
    ALUMOX 
    aluminum hydroxide, magnesium hydroxide, simethicone tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53041-152
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE200 mg
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE200 mg
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MANNITOL (UNII: 3OWL53L36A)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    RAW SUGAR (UNII: 8M707QY5GH)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize15mm
    FlavorLEMONImprint Code G152
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53041-152-16100 in 1 BOTTLE; Type 0: Not a Combination Product06/06/2004
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33106/06/2004
    Labeler - Guardian Drug Company (119210276)
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